Cellceutix Q1 2017 Conference Call Transcript L
Post# of 72440
Posted On: 11/15/2016 11:58:26 PM
Cellceutix Q1 2017 Conference Call Transcript
Leo Ehrlich – Chief Executive Officer
Arthur P. Bertolino – President and Chief Medical Officer
Analysts
Operator
Good morning and welcome to the Cellceutix Corporation First Quarter Fiscal 2017 conference call. Please be advised that today's conference is being recorded following management’s prepared remarks we will be answering questions from investors that were submitted in advance. If anyone has questions after the call you may contact Crescendo Communications at 212-671-1021.
Before we begin I would like to remind listeners that this call will contain forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans other statements regarding future product developments and any other states that's which are not historical facts. These statements involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to different materially from anticipated results and expectations expressed in these forward-looking statements.
Cellceutix has in some cases identified forward-looking statements by using words such as anticipate, believe, hopes, expects, plans, intends, goal, potential, may and similar expressions among other factors that could cause actual results to differ materially from those expressed in forward-looking statements, are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission, which is available at sec.gov on cellceutix.com. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
At this time I'll turn the call over to Leo Ehrlich, Chief Executive Officer at Cellceutix. Please go ahead, Leo.
Leo Ehrlich
Thank you, David and thank you for everyone for attending this conference call. I'd like to provide an overview of the quarter ended September 30 before passing the call to Dr. Arthur Bertolino for more details on our pipeline.
First and foremost, our new fiscal year got off to a great start as we significantly strengthened our team with the addition of Dr. Bertolino as President and Chief Medical Officer, Jane Harness, Vice President of Clinical Sciences and Portfolio Management and LaVonne Lang to the role of Vice President of Regulatory Affairs.
These three individuals are extremely accomplished in their respective fields. They bring about 70 years of drug development experience to Cellceutix earned during their highly relevant positions at major pharmas like Parke-Davis, Pfizer and Novartis. In a brief time here at Cellceutix, they’ve immediately proven to be extremely valuable and efficiently moving our pipeline forward.
Now let me summarize our financial performance. Balance sheet overview. At September 30 2016, the Company had approximately $5.6 million in cash compared to approximately $6.3 million in cash at June 30, 2015. Stockholders’ equity was approximately 2.1 million compared to approximately 3 million at June 30, 2015. The current primary potential source of cash available to the company are equity investments through its equity purchase agreement with Aspire Capital. Company has financed its operation to date through the sale of its common stock. Company has raised approximately $8.2 million for the fiscal year ended June 30, 2016 through its equity purchase agreement with Aspire Capital.
Operating results fiscal 2016 compared to fiscal 2015. For the fiscal year ended June 30, 2016, the company's net loss was approximately $12.9 million or loss of $0.11 a share. For fiscal year ended June 30, 2015, the loss of $13.1 million or a loss per share of $0.11. Stock-based compensation expense was $0.7 million for the year ended June 30, 2016 compared to $0.4 million for the fiscal year ended June 30, 2015. For the fiscal year ended June 30, 2016, the company's cash flows using operating activities were $9.9 million versus $13.1 million for the fiscal year ended June 30, 2015. This is primarily due to a decrease in our operating expenses which includes research and development expenses in 2016.
As for our pipeline, the recent weeks included what I considered to be some of the most important milestones in the history of Cellceutix. I say this because I believe the discoveries and advancements that we have recently made are proving the real potential of our drug candidates and are attracting attention from larger peers.
During the past few months we have engaged in more business development have had more high-level meetings than any time in the company's history. From the minute we acquired Brilacidin in 2014 we have never doubted the efficacy of the compound as an antibiotic. That said we are confident that there is much greater value in the anti-inflammatory and immunomodulatory properties of the compound as the flagship drug in new class of drugs called defensin mimetics.
During September we received initial comments on the first patient enrolled in our Phase 2 trial of Brilacidin for the inflammatory bowel disease, IBD, ulcerative proctitis or ulcerative proctosigmoiditis which detailed a significant decrease in symptoms within one week of Brilacidin activity. Early in the current quarter we followed that up with even better news of clinically meaningful improvements in the first four patients of the first cohort who completed the trial at the lowest dosing level. Yes, the lowest grossing level. Dr. Bertolino will provide some more color on the results. But the key is the fact that Brilacidin concentrations in the patient's plasma at all timeframes were basically undetectable. This is incredibly important in the safety profile that is being built for the FDA. We believe that a highly effective new drug with minimal systemic exposure will have competitive advantages to capture market share in a market for IBD medicine, the vision gain forecast to client to $9.3 billion in 2019.
Given the notoriously hard to treat nature of inflammatory bowel disease and the need for an effective new class of medicine, we think that the latest date on Brilacidin increases the value of the asset many-fold. Should similar results of efficacy and safety continue throughout this trial, we believe it will be a sort after drug by big pharma. The anti-inflammatory properties seen in ulcerative proctitis support our optimism in the Phase 2 trial of Brilacidin-OM for head and neck cancer patients, suffering from oral mucositis.
By definition, oral mucositis is an inflammatory condition. Having data, demonstrating Brilacidin can fight inflammation and doesn't accumulate in the blood is a major benefit for what can be a painful and expensive condition that doesn't have any FDA approved treatments. We greatly look forward to additional data from this trial expected in the first half of 2017. We also advance our lead cancer drug Kevetrin. Since successfully completing the Phase one trial of Kevetrin and advanced solid tumors at Dana-Farber and Partners, top line data and determine that a small Phase 2a trial in ovarian cancer is the best route to build value. For basically every drug there is research that unlocks value. For Kevetrin big pharma wants to see exactly how Kevetrin modulates p53 within the tumor. That is an important goal of the planned Phase 2a study.
Elsewhere, we are very excited about our research in developing an oral formulation of Kevetrin. For those that are unaware to Takeda CEO, Christophe Weber, said only days ago, that there is new multiple myeloma drug, NINLARO is rolling out even faster than expected in the U.S. NINLARO is the world's first orally active protozoan inhibitor to market. Weber believes it will be even bigger than the blockbuster VELCADE and reach $3 billion in annual sales. So we dosed once per week by infusion in the Phase one Kevetrin trial. Kevetrin has an approximate 2 hour half-life. If we can develop an oral Kevetrin dosing possibilities are numerous. Perhaps two times or three times a day and seven days a week. Now you know why we are excited. A drug activating p53 and dosed orally, we think would have blockbuster potential. More research needs to be done to validate the clinical effectiveness of Kevetrin as well as developing an oral formulation. But I’d hope investors now understand why we get excited about the possibility of developing both the world's first safe p53 modulating drug and an oral formulation.
Our third unique drug candidate development has emerged from the shadows, if you will. I say this because for many years Prurisol was referred to as our dark horse or long shot, as some people called it in the early stage. However following two successfully completed clinical trials and with a Phase 2b now underway that attitude has changed and pharmas are starting to recognize the value of our oral drug for treating chronic plaque psoriasis. I don't know if anything exemplifies the value that the market gives to a drug like Prurisol better than Allergan agreeing to buy Vitae Pharmaceuticals for $639 million in September. Allegan paid 159% premium primarily to get control of Vitae’s two clinical drug candidates; one, in oral drug for psoriasis and other autoimmune disorders and the other candidate for eczema. Vitae’s most advanced VTP-43742 is actually slightly behind clinical development of Prurisol for treating psoriasis, as we beat them to the punch by initiating a Phase 2b trial in October, ahead of their planned Phase 2b study.
I believe that a Prurisol can deliver results in the Phase 2b study that showed the drug can safely and effectively treat moderate to severe chronic plaque psoriasis. I would hope the value Prurisol to easily exceed our current market capitalization and attract partners. Over the years we have gone from a company with only a single lead drug candidate in an early clinical study to a company that has effectively has three lead drug candidates at mid-state trials targeting multiple indications with new possibilities cropping up regularly underscored by our robust pipeline. We're having success at targeting multi-billion dollar opportunities with new drugs that can provide relief for millions of people worldwide suffering from hard-to-treat maladies. I believe that is more than ample reason to be excited about all that we have accomplished our future and the litany of catalyst expected in 2017.
With those remarks, I would like to now turn the call over to Dr. Bertolino. Thank you.
Arthur P. Bertolino
Hello, everyone I'm Arthur Bertolino and I'm pleased to provide this investor and shareholder update presentation highlighting our status regarding the various development programs at Cellceutix. Here you see that we have a robust portfolio of first-in-class drug candidates. There are three lead drug candidates some with various special FDA designations. The first is Prurisol, which is our orally delivered psoriasis drug candidate currently in a Phase 2b trial utilizing advantages of the 505(b)(2) development approach.
Second is Kevetrin, our p53 modulating drug candidate with three orphan drug designations starting Phase 2a trial for ovarian cancer. And finally Brilacidin is our drug candidate in a new antibiotic class with unique immunomodulatory properties advancing in clinical trials under fast-track designations. The pipeline is distributed here by clinical asset in therapeutic areas. You see we span dermatology, cancer, infectious disease and gastrointestinal indications with our three candidates Prurisol, Kevetrin and Brilacidin.
The indications indicated in dark black are the ones that are currently being pursued and there are a number of potentially future indications. Some of these overlap between the therapy areas such as oral mucositis between dermatology and cancer. Under inflammatory bowel diseases, we have begun an effort in ulcerative colitis and will hopefully be able to extend that further in dealing with Crohn's disease.
This next slide shows our pipeline, various stages of development and special FDA designations. You can see that we're a mid-Phase company and clinical development to cross this different number of indications that I've already mentioned. And if you look below at the FDA area, we leverage various designations from FDA to expedite development including orphan drug designation, rare disease, QIDP and fast-track designations. These all improve the likelihood of drug approval and gaining added market exclusivity.
Here you see our anticipated upcoming clinical milestones. This basically spans the next year and a half and is really distributed among our different programs with milestones that actually can act as significant catalysts for further growth of our company. You'll see the first two indications here are psoriasis and ulcerative proctitis. We've delivered already on these milestones with the beginning of our Phase 2b trial for psoriasis in the early part of fourth quarter and also on the first interim analysis in our Phase 2a ulcerative proctitis trial. These provide really good encouragement for the continuation of our delivering on our pipelines. We anticipate starting the ovarian cancer Phase 2a trial which is going to be focused on establishing the mechanism of action of our drug Kevetrin later this quarter or at the latest probably early first quarter of 2017.
Then for the first half of 2017, you'll see we'll have periodic deliverables including an interim analysis of our psoriasis Phase 2b study. We're going to have an interim analysis of our oral mucositis study and we're going to complete the Phase 2a trial for ulcerative proctitis. Later in the year in the second half, we expect to be able to complete our Phase 2b trial for psoriasis. Complete our ovarian cancer proof-of-concept and complete the Phase 2 trial for oral mucositis. We have plans for an ABSSSI study in Phase 3 which timetable is really dependent on reaching special protocol assessment agreement with FDA.
Let me move right into our first program Prurisol for psoriasis. Again what we have here is a first-in-class oral psoriasis drug candidate Prurisol. Psoriasis is fairly common in the U.S. it affects up to about 8 or 9 million people and about 3 million of those people have moderate to severe psoriasis. Because this shows it's obvious there's a large psychosocial component to this where people feel that they suffer discrimination and humiliation and they really want to do something when they're afflicted with this problem.
On this next slide you'll see the mechanism of action that we are beginning to understand regarding our drug candidate Prurisol. That drug candidate is shown in a chemical format on the right portion of the slide and the area that is being circled here to the left is the glycolic acid component which when through an ester linkage to the remaining part of the molecule is abacavir glycolate. This abacavir glycolate works through immune modulation and PRINS reduction. PRINS is a psoriasis associated non-protein coding RNA that gets induced by stress.
The various attributes of Prurisol are that it is a new chemical entity with strong intellectual property and patent protection via a composition of matter patent good through the early 2030s and a unique advantage of being able to use the reference drug abacavir or ZIAGEN is the trademark name for it, as a reference drug to accelerate our development program. This utilizes advantages of a 505(b)(2) type approach where the long-term safety of the drug can be referenced to abacavir because abacavir is a major metabolite of Prurisol.
We are fortunate that we have achieved favorable efficacy results in our first Phase 2 trial in mild to moderate chronic plaque psoriasis and we have the advantage of oral dosing small molecule that's well bioavailable and has excellent in vivo and in vitro activity. Our preclinical program has already demonstrated efficacy in a xenograft model. And one point that is very important to understand is that when our abacavir glycolate Prurisol is metabolized, it's metabolized by breakage of the ester linkage to form glycolic acid and abacavir, that's why abacavir can be used as the reference drug for long-term safety because it is formed by the metabolic action of esterases on Prurisol. It's very important to realize that the abacavir has no benefit for psoriasis. So even though it is a drug that is on the market for antiviral indications at this point it is not something that could be beneficial for the treatment of psoriasis.
On the next slide you see our proof-of-concept trial that was completed earlier this year. It was done in mild to moderate plaque psoriasis with the primary efficacy endpoint being the percentage of subjects who have at least a two point improvement on an investigator global assessment rating after 12 weeks of treatment. This involves an IGA rating of clear, which is zero, almost clear, which is one, mild which is 2, moderate which is 3, 4 is severe and 5 is very severe. This was a randomized double-blind placebo-controlled parallel group study. Had four treatment groups divided equally for randomization the patients were treated either with 50 milligrams, 100 milligrams or 200 milligrams of Prurisol or placebo over 12 weeks. The trial was conducted at nine sites with a 115 subjects distributed among the four arms and we looked at efficacy safety and pharmacokinetics.
Here you see the results in the 200 milligram group, our highest dosing treatment group. We note that over time the IGA begins to change as soon as two weeks and there are progressive decreases in the IGA scores to lower values over the 12 weeks of treatment. There's a time-based transition in the original moderate and mild population of psoriatics to less psoriasis activity with emergence of almost clear and clear groups. This is displayed in the graph below. At week 12 42.8% of the intent-to-treat population achieved clear or almost clear and as far as our primary endpoint in the per-protocol population at approximately 35% of all patients in this 200 milligram per day treatment group met that primary endpoint. When we actually looked and focused just on the moderate psoriatics, the IGA 3 group, the primary endpoint was met in 46% of patients.
Let me draw your attention to this line graph on the left. This is really why we feel we have compelling data that suggests psoriasis will respond well with his drug candidate. If you look at time zero and focus on the green line which is the IGA three group moderate psoriatics, you'll see they represent 67.9% of the starting population. The rest of the population are represented at time zero by the purple line showing about the other third of patients had mild psoriasis, that's IGA 2. As time goes on and you see the emergence of the yellow line and a red line, the yellow line is IGA 1, which is almost clear and the red line is IGA 0 which is clear, meaning they have no active psoriasis.
So what happens in this population as a function of time, they start off with two-thirds moderate and one-third mild psoriasis. By two weeks you see the moderate group decreases and the mild group increases that's because people who have moderate psoriasis are improving and becoming mild psoriatics at that point. As time goes further on between four and six weeks you see the emergence of the almost clear population. Those people are people who are significantly improved from the original mild and moderate group and they continue to improve in numbers out to 12 weeks, representing about 32% at that point. Between eight and 12 weeks you see the emergence of the clear group and that group totals out about 10% or 11% percent by week 12.
Of note also is that by six weeks, the bulk of this response has already happened, so there is a relatively early response in terms of the treatment course which is always something that is well received by patients. There was one serious adverse event in the 50 milligram dose group and not in the higher dose groups. So that was not a dose relationship to that and the PK results showed a dose-dependent increase in drug exposure and maximum plasma concentration. These data are compelling for an early Phase 2a study and lead us to believe that we will continue to see very favorable results as we go on to our next study.
The primary efficacy endpoint in this trial was met with very impressive results in the 200 milligram group showing the highest magnitude of effect. We saw this progressive decrease in IGA scores to lower values as early as two weeks and continuing to improve out to 12 weeks in the 200 milligram group. And there was sufficient clinical improvement to warrant more detailed examination of responses to treatment at the 200 milligram level and higher doses. Prurisol was generally well tolerated and as you can see two-thirds of the subjects in the 200 milligram group having a moderate psoriatic IGA of three had favorable responses and serves as a bridge to investigate Prurisol in a moderate to severe psoriasis population, as opposed to the mild to moderate population, that was examined in this first study.
We've actually just begun Phase 2b trial evaluating higher dose regimens of 300 milligrams and 400 milligrams in moderate to severe psoriasis using the proportion of subjects achieving a PASI75 score at Week 12 as the primary endpoint. This is one of the main endpoints used for Phase 3 registration studies.
Here you see the design of our Phase 2b clinical trial in moderate-to-severe plaque psoriasis. We are currently enrolling patients its randomized double-blind parallel-group and placebo control. There are Prurisol 300 milligram group of patients, placebo group and Prurisol 400 milligram group of patients distributed in a 3:3:1 randomization. The number of subjects anticipated for this trial is a 189. The treatment duration will be 12 weeks with an interim read out in the second quarter of 2017 and we anticipate approximately 30 sites to enroll patients for this study. You can see the study design schematic here on the right on the slide and it's very similar to what you've seen in the previous study design.
There's a significant market opportunity and very favorable competitive landscape for Prurisol treatment and psoriasis. Otezla, the Celgene product is emerging as a blockbuster drug. It's the main potential oral competitor, but actually only demonstrates moderate efficacy by week 16. If you focus on the line graph on the left hand side of this slide, the blue line shows the PASI75 readings, that is three-quarters improvement in psoriasis as a function of time, its PASI75. And you'll see that the deliverable in terms of percentage of patients with treatment maxes out at about 28%. Celgene with these results is currently earning revenue of up to $1 billion this year and targeting $2 billion dollars in 2017. Because of this favorable competitive landscape, there have been a number of recent psoriasis deals. One is Allergan and Vitae. Vitae had this product which is under development and actually a little bit earlier in development than our psoriasis drug candidate. And because it modulates Interleukin 17 and there are biologic drugs which have made it to market and shown effectiveness based on modulating IL-17 that deal was recently completed for $640 million.
Similarly, Dr Reddy's Lab did a deal XenoPort which is a fumaric acid type drug for $0.5 billion and there was also a similar deal in terms of magnitude between BI and AbbVie in that case for an anti-IL-23 monoclonal antibody. So industry has realized there is a space out there where there is a need and this is focused on psoriasis specifically in the oral delivery of drugs to complement the biologic results on and there is a significant market opportunity.
Let me move on to Kevetrin for cancer. This is our first-in-class p53-modulating oncology compound. Where we stand at this point is that we have multiple FDA orphan drug designations and are starting a Phase 2a trial for platinum-resistant ovarian cancer. As you can see this drug candidate induces apoptosis, hits multiple molecular targets and signaling pathways, is non-genotoxic in its induction of apoptosis and does not affect normal cell viability at concentrations that kill tumor cells. It's been well-tolerated with minimal adverse effects in our completed Phase 1 clinical trial.
As far as p53 being central among many different types of cancer, you'll notice that p53 especially ovarian cancer and p53 is high on the list on the left. Our current perspectives are that our Phase 1 trial and advanced solid tumors is supportive of our proceeding with ovarian cancer as an indication. We look at p53 pathway modulation to be measured in an upcoming small ovarian cancer trial to absolutely establish the mechanism of action. And we also believe that we need to shift from our current intravenous formulation to an oral formulation because that better aligns with the short half-life of the drug and should allow us to dose multiple times per day and should probably give us enhanced drug exposure and toleration.
Here you see our top line results from our Phase 1 trial in advanced solid tumors and the thing I'd really like to just bring to your attention is that in subjects with ovarian cancer 60% had an increase in a downstream marker of p53 that markers p21 that ranged in response of 3% to 73% increase. There were good tolerations of the patients who took the drug in this study and there was one nonserious Grade 3 infusion related reaction, which was a low blood pressure episode without any other significant hematologic or systemic effects and pharmacokinetics were also favorable.
What we're planning to do with our Phase 2a trial that's upcoming for late-stage ovarian cancer is to dose with Kevetrin three times a week IV over three weeks. We're going to have two dosing groups and just a small number of patients, five in each group for a total of 10 patients in the study and that initial treatment will be followed by standard of care treatment with Doxil every four weeks for the standard four to six cycles. We're going to look at safety and efficacy and we're going to look at pharmacokinetics. But the real important goal here is to established without any doubt the mechanism of action being modulation of the p53 pathway.
Let me move on to the Brilacidin franchise, this is the first-in-class Host Defense Protein mimetic. It has anti-inflammatory as well as antimicrobial drug actions and it works by insertion into the bacterial membranes, giving it antibacterial effects. But it has a number of immunomodulatory capabilities, which make its indication of possibility for different disorders very, very attractive in that regard as well, beyond just being an antimicrobial. It has received an FDA QIDP Fast Track designation for acute bacterial and skin and skin structure infections. But we also have these very exciting anti-inflammatory indications, which I'll describe as we go on.
In that regard, we have programs across GI, dermatology and cancer as well as the infectious disease categories. What you may have heard about recently was our exciting results in our first look in inflammatory bowel disease where we are treating in an open-label fashion ulcerative proctitis and ulcerative proctosigmoiditis which is a subtype of ulcerative colitis under the umbrella of inflammatory bowel disease, I'll explain those results shortly. We also have an ongoing oral mucositis trial, which should give us an interim analysis in the first half of 2017 and we've had a successful ABSSSI study Phase 2b.
Here you see our study that's still ongoing. It’s a Phase 2a trial for ulcerative proctitis and ulcerative proctosigmoiditis. It's open-label sequential dose-escalation and there are three cohorts of six people each. They get a retention enema once-daily for 42 days and at this point we've started to look at the patients in our first cohort, the low-dose in group of 50 milligrams. There are two subsequent cohorts planned of 100 milligrams and 200 milligrams and we're looking both at clinical and endoscopic remission in the course of the study. There is a scale called Modified Mayo Disease Activity Index and when it just looks at the clinical results, it's called the Partial MMDAI. And in looking at the first four patients in our first cohort, two of those four subjects achieved a full response, 100% reduction and the other half had notable improvement.
When we looked at the full MMDAI, which includes the endoscopic review one of three subjects who had the endoscopy both before and after treatment had a full response and two of the other three had notable improvement. When we look at patient quality of life there was improvement over the six-week treatment period safety exhibited generally well-tolerated results and very interestingly the drug concentrations in plasma or all below the lower limit of quantification below a 100 nanograms per milliliter. That means that we can treat locally without getting any significant systemic exposure. It was very limited by what we saw in this first study. That encourages us to believe that when we treat locally such as in the GI track we may have very limited systemic exposure for a number of different indications.
Here you see what's happening in terms of our oral mucositis program there is an ongoing Phase 2 trial in progress and those first looks will be from an interim analysis in the first half of 2017. The reason we're very excited about this particular indication is because of the results preclinical in our acute radiation model and Hamsters. When you look in the upper left hand corner of the slide, you'll notice the high bar in vehicle column shows a high percentage of animal days with significant oral mucositis. In the next dosing group to the right, you'll notice at the low dose of Brilacidin that's reduced. And at the higher doses and circled by the red line here, you'll see that there's a marked reduction in oral mucositis to the point of over 90% reduction with those higher dosing groups.
The animal models as you see below that in general demonstrated from other drugs that are being looked at for oral mucositis translates fairly well into the clinical results. You see in the effect on animal model column for a number of the drugs. The numbers are not so dissimilar from what you end up seeing in the clinic. So when we see a 94% percent reduction with Brilacidin we really are excited to see our upcoming interim Phase 2 results that will be out in the first half of 2017.
I mentioned the study is a Phase 2 study. Its randomized multicenter double-blind placebo-controlled. The total number of subjects is planned for 60; it's a swish and spit on oral type of administration of the drug, daily three times for seven weeks and our primary endpoints are to look at the control and prevention of oral mucositis and patients who have chemo radiation induced oral mucositis in the course of their treatment for Head and Neck Cancer. So we're hoping to really see a delayed onset of severe oral mucositis and if it does occur to see a diminution of its effects.
Here you see the overview of our ABSSSI Phase 2b clinical trial results and I'll just draw your attention to the comparator, which was Daptomycin established treatment for ABSSSI treated daily for seven days resulted in a clinical response of about 93.8% and our lowest dose group of 0.6 milligrams per kilogram Brilacidin achieved a non-inferior result of 92.2%. And as the doses were higher and for longer duration somewhat even further improved clinical responses were achieved. So in general the results were good for safety and efficacy. It was a convenient single dose regimen and comparable just dosing once to the seven-day regiment of a robust comparator Daptomycin for seven days. We have this QIDP designation from FDA which makes us eligible for fast track and priority review. And we're enthusiastic that there's minimal potential for development of resistance, where we stand with this program right now is we're working on a response for a special protocol assessment to get FDA approval. And at that point we would establish what would be necessary for an appropriate Phase 3 program.
So in closing I'd like to thank you for listening to this presentation and for your interest in Cellceutix.
Question-and-Answer Session
Operator
We will now move on to the question-and-answer portion of this presentation. Understand that with consideration for time that we cannot possibly answer all of the questions that we receive. Many were similar in content and those are the ones that we are responding to today.
Unidentified Analyst
Our first question you mentioned discussion with potential partners, which are the three drugs is garnering the most attention and what do you think is the potential timeline to a partnership or what additional clinical results would be required first?
Leo Ehrlich
Okay. Which are the drugs that’s garnering the most attention is relative depending on developments. For example, if the development comes about with Prurisol discussions with potential partners are more prominent at that moment. We are fortunate that all three of our drug candidates have appealed for partnering opportunities. The momentum that we are experiencing with our psoriasis program entering Phase 2b has produced significant current interest in Prurisol. Likewise our recent encouraging reported interim results with Brilacidin and ulcerative proctitis, ulcerative proctosigmoiditis have gained notice because of its potential for use even more broadly in inflammatory bowel disease. As far as our cancer program with Kevetrin, we believe that the position for partnering will be once we have data from our small Phase 2a study that is in preparation aimed to firmly establish the p53 modulation in the tumor as the mechanism of action and as we transition into oral dosing formulation. As far as timelines for potential partners, it's inappropriate for management to discuss that. It is more prudent for us to take into consideration what a potential partner wants and make that happen.
Operator
Thank you. Our next question.
Unidentified Analyst
Brilacidin seems to have very broad potential across a number of indications. Can you comment on why you chose to start with inflammatory bowel disease and ulcerative proctitis? Can you expand on the critical path for these indications and what other indications would you consider pursuing?
Leo Ehrlich
There is currently a significant medical need for effective treatment of inflammatory bowel disease. We look for massive markets with unmet needs, so IBD certainly qualified. The simplest way for us to do a proof-of-concept evaluation was to first explore ulcerative proctitis, ulcerative proctosigmoiditis. We have certainly been encouraged by preliminary results if it holds true that we can achieve significant clinical benefits with localized treatment and no significant systemic drug levels. We also anticipate potential for use in expanding IBD indications and in a number of dermatological diseases.
Operator
Thank you. Our next question.
Unidentified Analyst
Even though it was only four patients, can you comment on the patients who completed the trial from Brilacidin in IBD at the lowest dosing level? How did you measure the improvement and how did that compare against your expectations? What are your expectations at higher dosing levels?
Leo Ehrlich
We discussed this in our press release on the preliminary data. So I encourage people to visit our news section for a more complete response on the data. The measures of improvement utilized the Modified Mayo Disease Activity Index. This included both clinical outcomes and improvement on endoscopic evaluation. It's fair to say that we were confident that we would be a clinical benefit in humans based upon our preclinical research. Going forward we are optimistic that we may see more pronounced effects as we administer higher doses.
Operator
Thank you. Our next question.
Unidentified Analyst
Can you comment on why it has taken so long to advance Kevetrin? And what the timeline is going forward? Are there any specific changes in the upcoming Phase 2a trial that will hasten the face of the study versus the first trial?
Arthur P. Bertolino
Some clinical trials simply take longer than hoped or expected and simply out of the hands of the sponsor company. Let's not also forget that we enrolled more patience than we expected and underscored by the fact that Kevetrin had such a strong safety profile. We've been extremely fortunate to get the input on Kevetrin from the experts at Dana-Farber and Beth Israel. The fact is that the trial was successfully completed and laid the groundwork for mid-states trials with the initial focus on ovarian cancer. In that regard we are currently preparing to launch a Phase 2a study in ovarian cancer, which we expect will progress exponentially faster now that we are armed with a larger clinical data state on Kevetrin. Significant expected change of protocol for the Phase 2a trial is patients being treated with Kevetrin three times per week for three weeks.
Enrollment will be a lot smaller than the initial trial with only about 10 patients. In addition we are taking the necessary steps the transitions oral dosing. We expect significant progress during the first half of 2017.
Operator
Thank you. Our next question.
Unidentified Analyst
If oral formulation of Kevetrin may not be ready for the anticipated trial, will there be opportunity to have this oral formulation later in the trial or future trials?
Leo Ehrlich
The upcoming Phase 2a ovarian cancer trial is proceeding with intravenous dosing. We are working toward shifting to all those and study later in 2017 after required bridging toxicology studies are completed.
Operator
Thank you. Our next question.
Unidentified Analyst
Any further info on the grants application for Kevetrin in trial with pancreatic cancer at Mayo Clinic?
Leo Ehrlich
Well, we missed the cutoff for obtaining the grant by very narrow margin based on the score received on the grant application. The challenge wasn't is the multi dosing needed for Kevetrin, that is why we are focused on our formulation work on Kevetrin. Oral dosage would be the best solution.
Operator
Thank you. Our next question.
Unidentified Analyst
Assuming the Phase 2b goes well to Prurisol. What would be the next steps? Do you plan to partner or commercialize the drug yourself?
Arthur P. Bertolino
Our next step would be to meet with the FDA for an end of Phase 2 meeting, to enable start of the Phase 3 registration studies. We intend to evaluate the situation at that time, should there be a partnering opportunity on the table. We could realistically conduct this program ourselves or include a partner if favorable.
Operator
Thank you. Our next question.
Unidentified Analyst
You added very senior industry professionals recently the team including Dr. Bertolino. Dr. Bertolino can you comments on what attracted you to the company at this stage? Also what is the current staffing level of the company? Do you have all the relevant people needed or are you looking to expand in any areas?
Arthur P. Bertolino
As for me joining the rationale is simple. It was the quality of the pipeline and the team developing the compounds. Everyone in the biotech space has a goal of developing blockbuster drugs that can help people in need. As I performed my due diligence on Cellceutix, I saw multiple shots on goals and wanted to be part of developing these drug candidates. More broadly our recent team addition better position us to efficiently deliver on these opportunities and I suspect that we will likely need to continue its expansion in a measured way as further milestones are achieved.
Operator
Thank you. Our next question.
Unidentified Analyst
If Prurisol shows excellent results in Phase 2b, would Cellceutix consider going head-to-head in a Phase 3 with Otezla?
Leo Ehrlich
While not required for registration in the U.S., a comparator trial can often be very informative. The final design of the Phase 3 program would be decided after consultation with FDA at an end of Phase 2 meeting.
Unidentified Analyst
Thank you. As a follow-on to that question assuming that Prurisol received FDA approval then what do you expect will be the peak yearly sales volume for Prurisol?
Arthur P. Bertolino
I'll answer that. It is way too early to start speculating about potential peak sales. The only response we can offer on that front is that Otezla is currently approaching $1 billion in sales. We would hope that any true competitor could take a considerable portion of that market which is also an expanding market.
Operator
Thank you. Our next question.
Unidentified Analyst
Do you expect that Prurisol will eventually be used to treat other diseases and conditions besides plaque psoriasis, such as psoriatic arthritis, rheumatoid arthritis, multiple myeloma et cetera?
Leo Ehrlich
We think that there are some potential opportunities that are certainly worth exploring in the future. We have conducted no research to date on any indication outside of psoriasis for Prurisol. It would be a reasonable expectation that Prurisol might demonstrate benefit in the conditions such as psoriatic arthritis. But that needs to be confirmed with some research. For now though we are only concerned with developing Prurisol for dermatological applications.
Operator
Thank you. Our next question.
Unidentified Analyst
Dr. Bertolino, can you explain more about what is known of the science underlying the anti-inflammatory actions of Brilacidin?
Arthur P. Bertolino
Brilacidin is an immunomodulatory and anti-inflammatory agent. It inhibits the production of a number of key molecular targets, TNF-alpha, IL- 1 beta, MCP-1, MMP-9 and IL-6. Recent encouraging results in ulcerative proctitis, ulcerative proctosigmoiditis reassure us that the science is meaningful.
Operator
Thank you. Our next question.
Unidentified Analyst
Dr. Bertolino, you have said that the hypersensitivity reaction with Prurisol does not occur - not a case with Prurisol, as long as one excludes those genetically predisposed to the reaction. Is the data that clear-cut?
Arthur P. Bertolino
In a study of ZIAGEN, abacavir in which the treated population of 2,000 subjects screen negative for the HLA-B*5701 allele, there were no cases of hypersensitivity reaction. This gives us confidence that the screening is very effective to guard against a significant likelihood that this might occur.
Operator
Thank you. Our next question.
Unidentified Analyst
Could you please give an update on your seeking corporate partners for sharing huge development costs, keeping selling equity to fund clinical trials and that way to go forward? What kind of partner are you looking for?
Leo Ehrlich
We maintain ongoing discussions with multiple potential corporate partners and also continue to develop new relationships. To that point we have signed CDA's with some of the world's largest pharmas and biotechs.
Operator
Thank you. Our next question.
Unidentified Analyst
Is Cellceutix simply attending or presenting at the upcoming Biotech Showcase conference?
Leo Ehrlich
We are presenting.
Operator
Thank you. Our next question.
Unidentified Analyst
What is the status of the special protocol assessment with the FDA for Brilacidin and for acute bacterial skin and skin structure infections?
Leo Ehrlich
Well, we're still negotiating with the FDA on this matter. There few points to take note of here. The FDA is predisposed to wanting to see certain things in a clinical study based upon earlier research. We don't believe certain components are necessary for our Phase 3 trial and are negotiating meaning that we are providing evidence to the FDA to support our contention to reach terms of the SPA. Concerning Brilacidin there is interest from companies. We need to keep developing the franchise for a multitude of indications, as we've said repeatedly that we've seen even greater opportunities based upon the anti-inflammatory and immunomodulatory properties of Brilacidin. ABSSSI is a very expensive trial. We have previously budget about $30 million for the trials. A previous question addressed dilution and we don't want to fund the trial at the current share price when we can make a better return on investment on completing our other trials until for example, our stock price recovers.
Operator
Thank you. Our next question.
Unidentified Analyst
The benefit is developing an oral formulation of Kevetrin are obviously with respect to patients and Kevetrin value. Please elaborate on impact with respect to trials. You have to do a Phase 1 trial. Will there be a significant delay in development of Kevetrin. The same questions are applicable for a foam version of Brilacidin or UPUC?
Arthur P. Bertolino
We can continue to advance Kevetrin in an IV form without any hesitation. Depending upon the required bridging toxicology studies we may be able to test initial dosing with the oral Kevetrin formulation in healthy volunteers then rapidly transition into those in patients with cancer. Meaning that it would not take long to have the oral and IV Kevetrin at the same point of development. The developmental pathway for a foam version of Brilacidin is similar. We aim to be efficient in our development plans across our portfolio.
Unidentified Analyst
There were many, many questions on potential partnerships to request for greater details. Cellceutix is conducting some of these discussions under strict confidentiality agreement and is not permitted to publicly disclose the name of possible partners or the nature of the negotiations. For the sake of brevity these questions that don't encroach on the NDAs have been combined into. Can you give us the up-to-the-moment status and some thoughts on discussions?
Leo Ehrlich
Let's look at our compounds, clinical trials and see where we are. Concerning Kevetrin, a successful short trial identifying p53 modulation in the tumor and a successful development of a formulation for frequent dosing is needed. Prurisol, we are now in a Phase 2b trial and big pharma knows about this trial. For Brilacidin, the big news and I will add that I think people aren't fully realizing how important this is, is that to-date that there's been no systemic exposure in the plasma in the UP study, which is extremely important if we see follow-through at higher doses. Extrapolating the localized treatment data to the Phase 2 oral mucositis trial speaks volumes to the potential of the oral rinse version of Brilacidin to treat the painful condition in Head and Neck Cancer patients undergoing chemo radiation therapy. We need to keep collecting data, but certainly opens the possibilities for uses in dermatology. Safety, efficacy, multiple applications these are the tenants of valuable drug development that command attention from big pharma. There is definitely a story here that is being developed and we look forward to sharing it as it unfolds.
Operator
Thank you. Our next question.
Unidentified Analyst
In my opinion stock price of Cellceutix does not reflect the value of the company's pipeline of products. How do you plan on increasing institutional ownership of the stock, investment from big pharma and increasing stock valuation?
Leo Ehrlich
I think that I speak for all of us in saying that we share the sentiment and our stock price does not reflect the value of our pipeline of drug candidates. As CEO I intend to steer clear of commentary beyond that on market valuation. Our job is to continue to produce and we're confident that the market will respond, which will include increased institutional ownership and hopefully investment for big pharma as we share our story at industry and invest in conferences.
Operator
Thank you. Our final question.
Unidentified Analyst
Have you ever thought about updating your company website?
Leo Ehrlich
Well, yes, actually we've been working on releasing in the website which we anticipate launching soon.
Leo Ehrlich – Chief Executive Officer
Arthur P. Bertolino – President and Chief Medical Officer
Analysts
Operator
Good morning and welcome to the Cellceutix Corporation First Quarter Fiscal 2017 conference call. Please be advised that today's conference is being recorded following management’s prepared remarks we will be answering questions from investors that were submitted in advance. If anyone has questions after the call you may contact Crescendo Communications at 212-671-1021.
Before we begin I would like to remind listeners that this call will contain forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans other statements regarding future product developments and any other states that's which are not historical facts. These statements involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to different materially from anticipated results and expectations expressed in these forward-looking statements.
Cellceutix has in some cases identified forward-looking statements by using words such as anticipate, believe, hopes, expects, plans, intends, goal, potential, may and similar expressions among other factors that could cause actual results to differ materially from those expressed in forward-looking statements, are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission, which is available at sec.gov on cellceutix.com. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
At this time I'll turn the call over to Leo Ehrlich, Chief Executive Officer at Cellceutix. Please go ahead, Leo.
Leo Ehrlich
Thank you, David and thank you for everyone for attending this conference call. I'd like to provide an overview of the quarter ended September 30 before passing the call to Dr. Arthur Bertolino for more details on our pipeline.
First and foremost, our new fiscal year got off to a great start as we significantly strengthened our team with the addition of Dr. Bertolino as President and Chief Medical Officer, Jane Harness, Vice President of Clinical Sciences and Portfolio Management and LaVonne Lang to the role of Vice President of Regulatory Affairs.
These three individuals are extremely accomplished in their respective fields. They bring about 70 years of drug development experience to Cellceutix earned during their highly relevant positions at major pharmas like Parke-Davis, Pfizer and Novartis. In a brief time here at Cellceutix, they’ve immediately proven to be extremely valuable and efficiently moving our pipeline forward.
Now let me summarize our financial performance. Balance sheet overview. At September 30 2016, the Company had approximately $5.6 million in cash compared to approximately $6.3 million in cash at June 30, 2015. Stockholders’ equity was approximately 2.1 million compared to approximately 3 million at June 30, 2015. The current primary potential source of cash available to the company are equity investments through its equity purchase agreement with Aspire Capital. Company has financed its operation to date through the sale of its common stock. Company has raised approximately $8.2 million for the fiscal year ended June 30, 2016 through its equity purchase agreement with Aspire Capital.
Operating results fiscal 2016 compared to fiscal 2015. For the fiscal year ended June 30, 2016, the company's net loss was approximately $12.9 million or loss of $0.11 a share. For fiscal year ended June 30, 2015, the loss of $13.1 million or a loss per share of $0.11. Stock-based compensation expense was $0.7 million for the year ended June 30, 2016 compared to $0.4 million for the fiscal year ended June 30, 2015. For the fiscal year ended June 30, 2016, the company's cash flows using operating activities were $9.9 million versus $13.1 million for the fiscal year ended June 30, 2015. This is primarily due to a decrease in our operating expenses which includes research and development expenses in 2016.
As for our pipeline, the recent weeks included what I considered to be some of the most important milestones in the history of Cellceutix. I say this because I believe the discoveries and advancements that we have recently made are proving the real potential of our drug candidates and are attracting attention from larger peers.
During the past few months we have engaged in more business development have had more high-level meetings than any time in the company's history. From the minute we acquired Brilacidin in 2014 we have never doubted the efficacy of the compound as an antibiotic. That said we are confident that there is much greater value in the anti-inflammatory and immunomodulatory properties of the compound as the flagship drug in new class of drugs called defensin mimetics.
During September we received initial comments on the first patient enrolled in our Phase 2 trial of Brilacidin for the inflammatory bowel disease, IBD, ulcerative proctitis or ulcerative proctosigmoiditis which detailed a significant decrease in symptoms within one week of Brilacidin activity. Early in the current quarter we followed that up with even better news of clinically meaningful improvements in the first four patients of the first cohort who completed the trial at the lowest dosing level. Yes, the lowest grossing level. Dr. Bertolino will provide some more color on the results. But the key is the fact that Brilacidin concentrations in the patient's plasma at all timeframes were basically undetectable. This is incredibly important in the safety profile that is being built for the FDA. We believe that a highly effective new drug with minimal systemic exposure will have competitive advantages to capture market share in a market for IBD medicine, the vision gain forecast to client to $9.3 billion in 2019.
Given the notoriously hard to treat nature of inflammatory bowel disease and the need for an effective new class of medicine, we think that the latest date on Brilacidin increases the value of the asset many-fold. Should similar results of efficacy and safety continue throughout this trial, we believe it will be a sort after drug by big pharma. The anti-inflammatory properties seen in ulcerative proctitis support our optimism in the Phase 2 trial of Brilacidin-OM for head and neck cancer patients, suffering from oral mucositis.
By definition, oral mucositis is an inflammatory condition. Having data, demonstrating Brilacidin can fight inflammation and doesn't accumulate in the blood is a major benefit for what can be a painful and expensive condition that doesn't have any FDA approved treatments. We greatly look forward to additional data from this trial expected in the first half of 2017. We also advance our lead cancer drug Kevetrin. Since successfully completing the Phase one trial of Kevetrin and advanced solid tumors at Dana-Farber and Partners, top line data and determine that a small Phase 2a trial in ovarian cancer is the best route to build value. For basically every drug there is research that unlocks value. For Kevetrin big pharma wants to see exactly how Kevetrin modulates p53 within the tumor. That is an important goal of the planned Phase 2a study.
Elsewhere, we are very excited about our research in developing an oral formulation of Kevetrin. For those that are unaware to Takeda CEO, Christophe Weber, said only days ago, that there is new multiple myeloma drug, NINLARO is rolling out even faster than expected in the U.S. NINLARO is the world's first orally active protozoan inhibitor to market. Weber believes it will be even bigger than the blockbuster VELCADE and reach $3 billion in annual sales. So we dosed once per week by infusion in the Phase one Kevetrin trial. Kevetrin has an approximate 2 hour half-life. If we can develop an oral Kevetrin dosing possibilities are numerous. Perhaps two times or three times a day and seven days a week. Now you know why we are excited. A drug activating p53 and dosed orally, we think would have blockbuster potential. More research needs to be done to validate the clinical effectiveness of Kevetrin as well as developing an oral formulation. But I’d hope investors now understand why we get excited about the possibility of developing both the world's first safe p53 modulating drug and an oral formulation.
Our third unique drug candidate development has emerged from the shadows, if you will. I say this because for many years Prurisol was referred to as our dark horse or long shot, as some people called it in the early stage. However following two successfully completed clinical trials and with a Phase 2b now underway that attitude has changed and pharmas are starting to recognize the value of our oral drug for treating chronic plaque psoriasis. I don't know if anything exemplifies the value that the market gives to a drug like Prurisol better than Allergan agreeing to buy Vitae Pharmaceuticals for $639 million in September. Allegan paid 159% premium primarily to get control of Vitae’s two clinical drug candidates; one, in oral drug for psoriasis and other autoimmune disorders and the other candidate for eczema. Vitae’s most advanced VTP-43742 is actually slightly behind clinical development of Prurisol for treating psoriasis, as we beat them to the punch by initiating a Phase 2b trial in October, ahead of their planned Phase 2b study.
I believe that a Prurisol can deliver results in the Phase 2b study that showed the drug can safely and effectively treat moderate to severe chronic plaque psoriasis. I would hope the value Prurisol to easily exceed our current market capitalization and attract partners. Over the years we have gone from a company with only a single lead drug candidate in an early clinical study to a company that has effectively has three lead drug candidates at mid-state trials targeting multiple indications with new possibilities cropping up regularly underscored by our robust pipeline. We're having success at targeting multi-billion dollar opportunities with new drugs that can provide relief for millions of people worldwide suffering from hard-to-treat maladies. I believe that is more than ample reason to be excited about all that we have accomplished our future and the litany of catalyst expected in 2017.
With those remarks, I would like to now turn the call over to Dr. Bertolino. Thank you.
Arthur P. Bertolino
Hello, everyone I'm Arthur Bertolino and I'm pleased to provide this investor and shareholder update presentation highlighting our status regarding the various development programs at Cellceutix. Here you see that we have a robust portfolio of first-in-class drug candidates. There are three lead drug candidates some with various special FDA designations. The first is Prurisol, which is our orally delivered psoriasis drug candidate currently in a Phase 2b trial utilizing advantages of the 505(b)(2) development approach.
Second is Kevetrin, our p53 modulating drug candidate with three orphan drug designations starting Phase 2a trial for ovarian cancer. And finally Brilacidin is our drug candidate in a new antibiotic class with unique immunomodulatory properties advancing in clinical trials under fast-track designations. The pipeline is distributed here by clinical asset in therapeutic areas. You see we span dermatology, cancer, infectious disease and gastrointestinal indications with our three candidates Prurisol, Kevetrin and Brilacidin.
The indications indicated in dark black are the ones that are currently being pursued and there are a number of potentially future indications. Some of these overlap between the therapy areas such as oral mucositis between dermatology and cancer. Under inflammatory bowel diseases, we have begun an effort in ulcerative colitis and will hopefully be able to extend that further in dealing with Crohn's disease.
This next slide shows our pipeline, various stages of development and special FDA designations. You can see that we're a mid-Phase company and clinical development to cross this different number of indications that I've already mentioned. And if you look below at the FDA area, we leverage various designations from FDA to expedite development including orphan drug designation, rare disease, QIDP and fast-track designations. These all improve the likelihood of drug approval and gaining added market exclusivity.
Here you see our anticipated upcoming clinical milestones. This basically spans the next year and a half and is really distributed among our different programs with milestones that actually can act as significant catalysts for further growth of our company. You'll see the first two indications here are psoriasis and ulcerative proctitis. We've delivered already on these milestones with the beginning of our Phase 2b trial for psoriasis in the early part of fourth quarter and also on the first interim analysis in our Phase 2a ulcerative proctitis trial. These provide really good encouragement for the continuation of our delivering on our pipelines. We anticipate starting the ovarian cancer Phase 2a trial which is going to be focused on establishing the mechanism of action of our drug Kevetrin later this quarter or at the latest probably early first quarter of 2017.
Then for the first half of 2017, you'll see we'll have periodic deliverables including an interim analysis of our psoriasis Phase 2b study. We're going to have an interim analysis of our oral mucositis study and we're going to complete the Phase 2a trial for ulcerative proctitis. Later in the year in the second half, we expect to be able to complete our Phase 2b trial for psoriasis. Complete our ovarian cancer proof-of-concept and complete the Phase 2 trial for oral mucositis. We have plans for an ABSSSI study in Phase 3 which timetable is really dependent on reaching special protocol assessment agreement with FDA.
Let me move right into our first program Prurisol for psoriasis. Again what we have here is a first-in-class oral psoriasis drug candidate Prurisol. Psoriasis is fairly common in the U.S. it affects up to about 8 or 9 million people and about 3 million of those people have moderate to severe psoriasis. Because this shows it's obvious there's a large psychosocial component to this where people feel that they suffer discrimination and humiliation and they really want to do something when they're afflicted with this problem.
On this next slide you'll see the mechanism of action that we are beginning to understand regarding our drug candidate Prurisol. That drug candidate is shown in a chemical format on the right portion of the slide and the area that is being circled here to the left is the glycolic acid component which when through an ester linkage to the remaining part of the molecule is abacavir glycolate. This abacavir glycolate works through immune modulation and PRINS reduction. PRINS is a psoriasis associated non-protein coding RNA that gets induced by stress.
The various attributes of Prurisol are that it is a new chemical entity with strong intellectual property and patent protection via a composition of matter patent good through the early 2030s and a unique advantage of being able to use the reference drug abacavir or ZIAGEN is the trademark name for it, as a reference drug to accelerate our development program. This utilizes advantages of a 505(b)(2) type approach where the long-term safety of the drug can be referenced to abacavir because abacavir is a major metabolite of Prurisol.
We are fortunate that we have achieved favorable efficacy results in our first Phase 2 trial in mild to moderate chronic plaque psoriasis and we have the advantage of oral dosing small molecule that's well bioavailable and has excellent in vivo and in vitro activity. Our preclinical program has already demonstrated efficacy in a xenograft model. And one point that is very important to understand is that when our abacavir glycolate Prurisol is metabolized, it's metabolized by breakage of the ester linkage to form glycolic acid and abacavir, that's why abacavir can be used as the reference drug for long-term safety because it is formed by the metabolic action of esterases on Prurisol. It's very important to realize that the abacavir has no benefit for psoriasis. So even though it is a drug that is on the market for antiviral indications at this point it is not something that could be beneficial for the treatment of psoriasis.
On the next slide you see our proof-of-concept trial that was completed earlier this year. It was done in mild to moderate plaque psoriasis with the primary efficacy endpoint being the percentage of subjects who have at least a two point improvement on an investigator global assessment rating after 12 weeks of treatment. This involves an IGA rating of clear, which is zero, almost clear, which is one, mild which is 2, moderate which is 3, 4 is severe and 5 is very severe. This was a randomized double-blind placebo-controlled parallel group study. Had four treatment groups divided equally for randomization the patients were treated either with 50 milligrams, 100 milligrams or 200 milligrams of Prurisol or placebo over 12 weeks. The trial was conducted at nine sites with a 115 subjects distributed among the four arms and we looked at efficacy safety and pharmacokinetics.
Here you see the results in the 200 milligram group, our highest dosing treatment group. We note that over time the IGA begins to change as soon as two weeks and there are progressive decreases in the IGA scores to lower values over the 12 weeks of treatment. There's a time-based transition in the original moderate and mild population of psoriatics to less psoriasis activity with emergence of almost clear and clear groups. This is displayed in the graph below. At week 12 42.8% of the intent-to-treat population achieved clear or almost clear and as far as our primary endpoint in the per-protocol population at approximately 35% of all patients in this 200 milligram per day treatment group met that primary endpoint. When we actually looked and focused just on the moderate psoriatics, the IGA 3 group, the primary endpoint was met in 46% of patients.
Let me draw your attention to this line graph on the left. This is really why we feel we have compelling data that suggests psoriasis will respond well with his drug candidate. If you look at time zero and focus on the green line which is the IGA three group moderate psoriatics, you'll see they represent 67.9% of the starting population. The rest of the population are represented at time zero by the purple line showing about the other third of patients had mild psoriasis, that's IGA 2. As time goes on and you see the emergence of the yellow line and a red line, the yellow line is IGA 1, which is almost clear and the red line is IGA 0 which is clear, meaning they have no active psoriasis.
So what happens in this population as a function of time, they start off with two-thirds moderate and one-third mild psoriasis. By two weeks you see the moderate group decreases and the mild group increases that's because people who have moderate psoriasis are improving and becoming mild psoriatics at that point. As time goes further on between four and six weeks you see the emergence of the almost clear population. Those people are people who are significantly improved from the original mild and moderate group and they continue to improve in numbers out to 12 weeks, representing about 32% at that point. Between eight and 12 weeks you see the emergence of the clear group and that group totals out about 10% or 11% percent by week 12.
Of note also is that by six weeks, the bulk of this response has already happened, so there is a relatively early response in terms of the treatment course which is always something that is well received by patients. There was one serious adverse event in the 50 milligram dose group and not in the higher dose groups. So that was not a dose relationship to that and the PK results showed a dose-dependent increase in drug exposure and maximum plasma concentration. These data are compelling for an early Phase 2a study and lead us to believe that we will continue to see very favorable results as we go on to our next study.
The primary efficacy endpoint in this trial was met with very impressive results in the 200 milligram group showing the highest magnitude of effect. We saw this progressive decrease in IGA scores to lower values as early as two weeks and continuing to improve out to 12 weeks in the 200 milligram group. And there was sufficient clinical improvement to warrant more detailed examination of responses to treatment at the 200 milligram level and higher doses. Prurisol was generally well tolerated and as you can see two-thirds of the subjects in the 200 milligram group having a moderate psoriatic IGA of three had favorable responses and serves as a bridge to investigate Prurisol in a moderate to severe psoriasis population, as opposed to the mild to moderate population, that was examined in this first study.
We've actually just begun Phase 2b trial evaluating higher dose regimens of 300 milligrams and 400 milligrams in moderate to severe psoriasis using the proportion of subjects achieving a PASI75 score at Week 12 as the primary endpoint. This is one of the main endpoints used for Phase 3 registration studies.
Here you see the design of our Phase 2b clinical trial in moderate-to-severe plaque psoriasis. We are currently enrolling patients its randomized double-blind parallel-group and placebo control. There are Prurisol 300 milligram group of patients, placebo group and Prurisol 400 milligram group of patients distributed in a 3:3:1 randomization. The number of subjects anticipated for this trial is a 189. The treatment duration will be 12 weeks with an interim read out in the second quarter of 2017 and we anticipate approximately 30 sites to enroll patients for this study. You can see the study design schematic here on the right on the slide and it's very similar to what you've seen in the previous study design.
There's a significant market opportunity and very favorable competitive landscape for Prurisol treatment and psoriasis. Otezla, the Celgene product is emerging as a blockbuster drug. It's the main potential oral competitor, but actually only demonstrates moderate efficacy by week 16. If you focus on the line graph on the left hand side of this slide, the blue line shows the PASI75 readings, that is three-quarters improvement in psoriasis as a function of time, its PASI75. And you'll see that the deliverable in terms of percentage of patients with treatment maxes out at about 28%. Celgene with these results is currently earning revenue of up to $1 billion this year and targeting $2 billion dollars in 2017. Because of this favorable competitive landscape, there have been a number of recent psoriasis deals. One is Allergan and Vitae. Vitae had this product which is under development and actually a little bit earlier in development than our psoriasis drug candidate. And because it modulates Interleukin 17 and there are biologic drugs which have made it to market and shown effectiveness based on modulating IL-17 that deal was recently completed for $640 million.
Similarly, Dr Reddy's Lab did a deal XenoPort which is a fumaric acid type drug for $0.5 billion and there was also a similar deal in terms of magnitude between BI and AbbVie in that case for an anti-IL-23 monoclonal antibody. So industry has realized there is a space out there where there is a need and this is focused on psoriasis specifically in the oral delivery of drugs to complement the biologic results on and there is a significant market opportunity.
Let me move on to Kevetrin for cancer. This is our first-in-class p53-modulating oncology compound. Where we stand at this point is that we have multiple FDA orphan drug designations and are starting a Phase 2a trial for platinum-resistant ovarian cancer. As you can see this drug candidate induces apoptosis, hits multiple molecular targets and signaling pathways, is non-genotoxic in its induction of apoptosis and does not affect normal cell viability at concentrations that kill tumor cells. It's been well-tolerated with minimal adverse effects in our completed Phase 1 clinical trial.
As far as p53 being central among many different types of cancer, you'll notice that p53 especially ovarian cancer and p53 is high on the list on the left. Our current perspectives are that our Phase 1 trial and advanced solid tumors is supportive of our proceeding with ovarian cancer as an indication. We look at p53 pathway modulation to be measured in an upcoming small ovarian cancer trial to absolutely establish the mechanism of action. And we also believe that we need to shift from our current intravenous formulation to an oral formulation because that better aligns with the short half-life of the drug and should allow us to dose multiple times per day and should probably give us enhanced drug exposure and toleration.
Here you see our top line results from our Phase 1 trial in advanced solid tumors and the thing I'd really like to just bring to your attention is that in subjects with ovarian cancer 60% had an increase in a downstream marker of p53 that markers p21 that ranged in response of 3% to 73% increase. There were good tolerations of the patients who took the drug in this study and there was one nonserious Grade 3 infusion related reaction, which was a low blood pressure episode without any other significant hematologic or systemic effects and pharmacokinetics were also favorable.
What we're planning to do with our Phase 2a trial that's upcoming for late-stage ovarian cancer is to dose with Kevetrin three times a week IV over three weeks. We're going to have two dosing groups and just a small number of patients, five in each group for a total of 10 patients in the study and that initial treatment will be followed by standard of care treatment with Doxil every four weeks for the standard four to six cycles. We're going to look at safety and efficacy and we're going to look at pharmacokinetics. But the real important goal here is to established without any doubt the mechanism of action being modulation of the p53 pathway.
Let me move on to the Brilacidin franchise, this is the first-in-class Host Defense Protein mimetic. It has anti-inflammatory as well as antimicrobial drug actions and it works by insertion into the bacterial membranes, giving it antibacterial effects. But it has a number of immunomodulatory capabilities, which make its indication of possibility for different disorders very, very attractive in that regard as well, beyond just being an antimicrobial. It has received an FDA QIDP Fast Track designation for acute bacterial and skin and skin structure infections. But we also have these very exciting anti-inflammatory indications, which I'll describe as we go on.
In that regard, we have programs across GI, dermatology and cancer as well as the infectious disease categories. What you may have heard about recently was our exciting results in our first look in inflammatory bowel disease where we are treating in an open-label fashion ulcerative proctitis and ulcerative proctosigmoiditis which is a subtype of ulcerative colitis under the umbrella of inflammatory bowel disease, I'll explain those results shortly. We also have an ongoing oral mucositis trial, which should give us an interim analysis in the first half of 2017 and we've had a successful ABSSSI study Phase 2b.
Here you see our study that's still ongoing. It’s a Phase 2a trial for ulcerative proctitis and ulcerative proctosigmoiditis. It's open-label sequential dose-escalation and there are three cohorts of six people each. They get a retention enema once-daily for 42 days and at this point we've started to look at the patients in our first cohort, the low-dose in group of 50 milligrams. There are two subsequent cohorts planned of 100 milligrams and 200 milligrams and we're looking both at clinical and endoscopic remission in the course of the study. There is a scale called Modified Mayo Disease Activity Index and when it just looks at the clinical results, it's called the Partial MMDAI. And in looking at the first four patients in our first cohort, two of those four subjects achieved a full response, 100% reduction and the other half had notable improvement.
When we looked at the full MMDAI, which includes the endoscopic review one of three subjects who had the endoscopy both before and after treatment had a full response and two of the other three had notable improvement. When we look at patient quality of life there was improvement over the six-week treatment period safety exhibited generally well-tolerated results and very interestingly the drug concentrations in plasma or all below the lower limit of quantification below a 100 nanograms per milliliter. That means that we can treat locally without getting any significant systemic exposure. It was very limited by what we saw in this first study. That encourages us to believe that when we treat locally such as in the GI track we may have very limited systemic exposure for a number of different indications.
Here you see what's happening in terms of our oral mucositis program there is an ongoing Phase 2 trial in progress and those first looks will be from an interim analysis in the first half of 2017. The reason we're very excited about this particular indication is because of the results preclinical in our acute radiation model and Hamsters. When you look in the upper left hand corner of the slide, you'll notice the high bar in vehicle column shows a high percentage of animal days with significant oral mucositis. In the next dosing group to the right, you'll notice at the low dose of Brilacidin that's reduced. And at the higher doses and circled by the red line here, you'll see that there's a marked reduction in oral mucositis to the point of over 90% reduction with those higher dosing groups.
The animal models as you see below that in general demonstrated from other drugs that are being looked at for oral mucositis translates fairly well into the clinical results. You see in the effect on animal model column for a number of the drugs. The numbers are not so dissimilar from what you end up seeing in the clinic. So when we see a 94% percent reduction with Brilacidin we really are excited to see our upcoming interim Phase 2 results that will be out in the first half of 2017.
I mentioned the study is a Phase 2 study. Its randomized multicenter double-blind placebo-controlled. The total number of subjects is planned for 60; it's a swish and spit on oral type of administration of the drug, daily three times for seven weeks and our primary endpoints are to look at the control and prevention of oral mucositis and patients who have chemo radiation induced oral mucositis in the course of their treatment for Head and Neck Cancer. So we're hoping to really see a delayed onset of severe oral mucositis and if it does occur to see a diminution of its effects.
Here you see the overview of our ABSSSI Phase 2b clinical trial results and I'll just draw your attention to the comparator, which was Daptomycin established treatment for ABSSSI treated daily for seven days resulted in a clinical response of about 93.8% and our lowest dose group of 0.6 milligrams per kilogram Brilacidin achieved a non-inferior result of 92.2%. And as the doses were higher and for longer duration somewhat even further improved clinical responses were achieved. So in general the results were good for safety and efficacy. It was a convenient single dose regimen and comparable just dosing once to the seven-day regiment of a robust comparator Daptomycin for seven days. We have this QIDP designation from FDA which makes us eligible for fast track and priority review. And we're enthusiastic that there's minimal potential for development of resistance, where we stand with this program right now is we're working on a response for a special protocol assessment to get FDA approval. And at that point we would establish what would be necessary for an appropriate Phase 3 program.
So in closing I'd like to thank you for listening to this presentation and for your interest in Cellceutix.
Question-and-Answer Session
Operator
We will now move on to the question-and-answer portion of this presentation. Understand that with consideration for time that we cannot possibly answer all of the questions that we receive. Many were similar in content and those are the ones that we are responding to today.
Unidentified Analyst
Our first question you mentioned discussion with potential partners, which are the three drugs is garnering the most attention and what do you think is the potential timeline to a partnership or what additional clinical results would be required first?
Leo Ehrlich
Okay. Which are the drugs that’s garnering the most attention is relative depending on developments. For example, if the development comes about with Prurisol discussions with potential partners are more prominent at that moment. We are fortunate that all three of our drug candidates have appealed for partnering opportunities. The momentum that we are experiencing with our psoriasis program entering Phase 2b has produced significant current interest in Prurisol. Likewise our recent encouraging reported interim results with Brilacidin and ulcerative proctitis, ulcerative proctosigmoiditis have gained notice because of its potential for use even more broadly in inflammatory bowel disease. As far as our cancer program with Kevetrin, we believe that the position for partnering will be once we have data from our small Phase 2a study that is in preparation aimed to firmly establish the p53 modulation in the tumor as the mechanism of action and as we transition into oral dosing formulation. As far as timelines for potential partners, it's inappropriate for management to discuss that. It is more prudent for us to take into consideration what a potential partner wants and make that happen.
Operator
Thank you. Our next question.
Unidentified Analyst
Brilacidin seems to have very broad potential across a number of indications. Can you comment on why you chose to start with inflammatory bowel disease and ulcerative proctitis? Can you expand on the critical path for these indications and what other indications would you consider pursuing?
Leo Ehrlich
There is currently a significant medical need for effective treatment of inflammatory bowel disease. We look for massive markets with unmet needs, so IBD certainly qualified. The simplest way for us to do a proof-of-concept evaluation was to first explore ulcerative proctitis, ulcerative proctosigmoiditis. We have certainly been encouraged by preliminary results if it holds true that we can achieve significant clinical benefits with localized treatment and no significant systemic drug levels. We also anticipate potential for use in expanding IBD indications and in a number of dermatological diseases.
Operator
Thank you. Our next question.
Unidentified Analyst
Even though it was only four patients, can you comment on the patients who completed the trial from Brilacidin in IBD at the lowest dosing level? How did you measure the improvement and how did that compare against your expectations? What are your expectations at higher dosing levels?
Leo Ehrlich
We discussed this in our press release on the preliminary data. So I encourage people to visit our news section for a more complete response on the data. The measures of improvement utilized the Modified Mayo Disease Activity Index. This included both clinical outcomes and improvement on endoscopic evaluation. It's fair to say that we were confident that we would be a clinical benefit in humans based upon our preclinical research. Going forward we are optimistic that we may see more pronounced effects as we administer higher doses.
Operator
Thank you. Our next question.
Unidentified Analyst
Can you comment on why it has taken so long to advance Kevetrin? And what the timeline is going forward? Are there any specific changes in the upcoming Phase 2a trial that will hasten the face of the study versus the first trial?
Arthur P. Bertolino
Some clinical trials simply take longer than hoped or expected and simply out of the hands of the sponsor company. Let's not also forget that we enrolled more patience than we expected and underscored by the fact that Kevetrin had such a strong safety profile. We've been extremely fortunate to get the input on Kevetrin from the experts at Dana-Farber and Beth Israel. The fact is that the trial was successfully completed and laid the groundwork for mid-states trials with the initial focus on ovarian cancer. In that regard we are currently preparing to launch a Phase 2a study in ovarian cancer, which we expect will progress exponentially faster now that we are armed with a larger clinical data state on Kevetrin. Significant expected change of protocol for the Phase 2a trial is patients being treated with Kevetrin three times per week for three weeks.
Enrollment will be a lot smaller than the initial trial with only about 10 patients. In addition we are taking the necessary steps the transitions oral dosing. We expect significant progress during the first half of 2017.
Operator
Thank you. Our next question.
Unidentified Analyst
If oral formulation of Kevetrin may not be ready for the anticipated trial, will there be opportunity to have this oral formulation later in the trial or future trials?
Leo Ehrlich
The upcoming Phase 2a ovarian cancer trial is proceeding with intravenous dosing. We are working toward shifting to all those and study later in 2017 after required bridging toxicology studies are completed.
Operator
Thank you. Our next question.
Unidentified Analyst
Any further info on the grants application for Kevetrin in trial with pancreatic cancer at Mayo Clinic?
Leo Ehrlich
Well, we missed the cutoff for obtaining the grant by very narrow margin based on the score received on the grant application. The challenge wasn't is the multi dosing needed for Kevetrin, that is why we are focused on our formulation work on Kevetrin. Oral dosage would be the best solution.
Operator
Thank you. Our next question.
Unidentified Analyst
Assuming the Phase 2b goes well to Prurisol. What would be the next steps? Do you plan to partner or commercialize the drug yourself?
Arthur P. Bertolino
Our next step would be to meet with the FDA for an end of Phase 2 meeting, to enable start of the Phase 3 registration studies. We intend to evaluate the situation at that time, should there be a partnering opportunity on the table. We could realistically conduct this program ourselves or include a partner if favorable.
Operator
Thank you. Our next question.
Unidentified Analyst
You added very senior industry professionals recently the team including Dr. Bertolino. Dr. Bertolino can you comments on what attracted you to the company at this stage? Also what is the current staffing level of the company? Do you have all the relevant people needed or are you looking to expand in any areas?
Arthur P. Bertolino
As for me joining the rationale is simple. It was the quality of the pipeline and the team developing the compounds. Everyone in the biotech space has a goal of developing blockbuster drugs that can help people in need. As I performed my due diligence on Cellceutix, I saw multiple shots on goals and wanted to be part of developing these drug candidates. More broadly our recent team addition better position us to efficiently deliver on these opportunities and I suspect that we will likely need to continue its expansion in a measured way as further milestones are achieved.
Operator
Thank you. Our next question.
Unidentified Analyst
If Prurisol shows excellent results in Phase 2b, would Cellceutix consider going head-to-head in a Phase 3 with Otezla?
Leo Ehrlich
While not required for registration in the U.S., a comparator trial can often be very informative. The final design of the Phase 3 program would be decided after consultation with FDA at an end of Phase 2 meeting.
Unidentified Analyst
Thank you. As a follow-on to that question assuming that Prurisol received FDA approval then what do you expect will be the peak yearly sales volume for Prurisol?
Arthur P. Bertolino
I'll answer that. It is way too early to start speculating about potential peak sales. The only response we can offer on that front is that Otezla is currently approaching $1 billion in sales. We would hope that any true competitor could take a considerable portion of that market which is also an expanding market.
Operator
Thank you. Our next question.
Unidentified Analyst
Do you expect that Prurisol will eventually be used to treat other diseases and conditions besides plaque psoriasis, such as psoriatic arthritis, rheumatoid arthritis, multiple myeloma et cetera?
Leo Ehrlich
We think that there are some potential opportunities that are certainly worth exploring in the future. We have conducted no research to date on any indication outside of psoriasis for Prurisol. It would be a reasonable expectation that Prurisol might demonstrate benefit in the conditions such as psoriatic arthritis. But that needs to be confirmed with some research. For now though we are only concerned with developing Prurisol for dermatological applications.
Operator
Thank you. Our next question.
Unidentified Analyst
Dr. Bertolino, can you explain more about what is known of the science underlying the anti-inflammatory actions of Brilacidin?
Arthur P. Bertolino
Brilacidin is an immunomodulatory and anti-inflammatory agent. It inhibits the production of a number of key molecular targets, TNF-alpha, IL- 1 beta, MCP-1, MMP-9 and IL-6. Recent encouraging results in ulcerative proctitis, ulcerative proctosigmoiditis reassure us that the science is meaningful.
Operator
Thank you. Our next question.
Unidentified Analyst
Dr. Bertolino, you have said that the hypersensitivity reaction with Prurisol does not occur - not a case with Prurisol, as long as one excludes those genetically predisposed to the reaction. Is the data that clear-cut?
Arthur P. Bertolino
In a study of ZIAGEN, abacavir in which the treated population of 2,000 subjects screen negative for the HLA-B*5701 allele, there were no cases of hypersensitivity reaction. This gives us confidence that the screening is very effective to guard against a significant likelihood that this might occur.
Operator
Thank you. Our next question.
Unidentified Analyst
Could you please give an update on your seeking corporate partners for sharing huge development costs, keeping selling equity to fund clinical trials and that way to go forward? What kind of partner are you looking for?
Leo Ehrlich
We maintain ongoing discussions with multiple potential corporate partners and also continue to develop new relationships. To that point we have signed CDA's with some of the world's largest pharmas and biotechs.
Operator
Thank you. Our next question.
Unidentified Analyst
Is Cellceutix simply attending or presenting at the upcoming Biotech Showcase conference?
Leo Ehrlich
We are presenting.
Operator
Thank you. Our next question.
Unidentified Analyst
What is the status of the special protocol assessment with the FDA for Brilacidin and for acute bacterial skin and skin structure infections?
Leo Ehrlich
Well, we're still negotiating with the FDA on this matter. There few points to take note of here. The FDA is predisposed to wanting to see certain things in a clinical study based upon earlier research. We don't believe certain components are necessary for our Phase 3 trial and are negotiating meaning that we are providing evidence to the FDA to support our contention to reach terms of the SPA. Concerning Brilacidin there is interest from companies. We need to keep developing the franchise for a multitude of indications, as we've said repeatedly that we've seen even greater opportunities based upon the anti-inflammatory and immunomodulatory properties of Brilacidin. ABSSSI is a very expensive trial. We have previously budget about $30 million for the trials. A previous question addressed dilution and we don't want to fund the trial at the current share price when we can make a better return on investment on completing our other trials until for example, our stock price recovers.
Operator
Thank you. Our next question.
Unidentified Analyst
The benefit is developing an oral formulation of Kevetrin are obviously with respect to patients and Kevetrin value. Please elaborate on impact with respect to trials. You have to do a Phase 1 trial. Will there be a significant delay in development of Kevetrin. The same questions are applicable for a foam version of Brilacidin or UPUC?
Arthur P. Bertolino
We can continue to advance Kevetrin in an IV form without any hesitation. Depending upon the required bridging toxicology studies we may be able to test initial dosing with the oral Kevetrin formulation in healthy volunteers then rapidly transition into those in patients with cancer. Meaning that it would not take long to have the oral and IV Kevetrin at the same point of development. The developmental pathway for a foam version of Brilacidin is similar. We aim to be efficient in our development plans across our portfolio.
Unidentified Analyst
There were many, many questions on potential partnerships to request for greater details. Cellceutix is conducting some of these discussions under strict confidentiality agreement and is not permitted to publicly disclose the name of possible partners or the nature of the negotiations. For the sake of brevity these questions that don't encroach on the NDAs have been combined into. Can you give us the up-to-the-moment status and some thoughts on discussions?
Leo Ehrlich
Let's look at our compounds, clinical trials and see where we are. Concerning Kevetrin, a successful short trial identifying p53 modulation in the tumor and a successful development of a formulation for frequent dosing is needed. Prurisol, we are now in a Phase 2b trial and big pharma knows about this trial. For Brilacidin, the big news and I will add that I think people aren't fully realizing how important this is, is that to-date that there's been no systemic exposure in the plasma in the UP study, which is extremely important if we see follow-through at higher doses. Extrapolating the localized treatment data to the Phase 2 oral mucositis trial speaks volumes to the potential of the oral rinse version of Brilacidin to treat the painful condition in Head and Neck Cancer patients undergoing chemo radiation therapy. We need to keep collecting data, but certainly opens the possibilities for uses in dermatology. Safety, efficacy, multiple applications these are the tenants of valuable drug development that command attention from big pharma. There is definitely a story here that is being developed and we look forward to sharing it as it unfolds.
Operator
Thank you. Our next question.
Unidentified Analyst
In my opinion stock price of Cellceutix does not reflect the value of the company's pipeline of products. How do you plan on increasing institutional ownership of the stock, investment from big pharma and increasing stock valuation?
Leo Ehrlich
I think that I speak for all of us in saying that we share the sentiment and our stock price does not reflect the value of our pipeline of drug candidates. As CEO I intend to steer clear of commentary beyond that on market valuation. Our job is to continue to produce and we're confident that the market will respond, which will include increased institutional ownership and hopefully investment for big pharma as we share our story at industry and invest in conferences.
Operator
Thank you. Our final question.
Unidentified Analyst
Have you ever thought about updating your company website?
Leo Ehrlich
Well, yes, actually we've been working on releasing in the website which we anticipate launching soon.
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