CTIX Stock Alert 08/10/2014 22:42:00 $CTIX Thanks
Post# of 64141
Posted On: 08/10/2014 11:42:15 PM
CTIX Stock Alert 08/10/2014 22:42:00 $CTIX
Thanks RJFL, I see the 200 mg/kg mouse doses on CTIX web site, and now looking back at the Kumar 2012 AACR poster, that in A549 lung carcinoma studies, 50 mg/kg Kevetrin was indistinguishable from controls, 100 mg/kg was better, 200 mg/kg better, and 2 cycles of 200 mg/kg best at delaying tumor growth.
I'm not really sure how to best scale these doses to humans, but scaling based on BSA seems like a good start. Of course the PK/PD differences between mice and humans matter greatly too. I'm sure the CTIX scientists have their models.
There was a nice point / counterpoint discussion of using BSA to dose cancer drugs (more for individual human dosage, not prediction of HED based on preclinical work):
http://www.nature.com/clpt/journal/v95/n4/abs...1412a.html
http://www.nature.com/clpt/journal/v95/n4/abs...0147a.html
"The historical rationale for using BSA-based dosing was to provide an allometric parameter for scaling dose determined in animals to humans, but that is not a sufficient argument to justify its use. Indeed, scaling has been used to determine the first level of dose of the first-in-human phase I study (usually 1/10 of the Lethal Dose 10)"
So if scaling animal to human BSA is not a good model for estimating efficacy equivalence (but only for starting dose), what is a better model?
I guess just use the animal data to estimate a safe starting point, then use the clinical trial data to determine efficacy and safety data? Maybe there are just too many variables for the simple BSA scaling to be useful, but I'd like to know what is a better general model.
Interesting idea about brilacidin for surgical prophylaxis. I work in the OR during many neurosurgical procedures, and IV antibiotics are usually given by the anesthesiologist / nurse anesthetist at the start of the case. I haven't seen powder form being used much. One of the orthopedic spine surgeons uses lots of antibiotic irrigation before closing, and has low infection rates, so maybe local wound application is a good idea in addition to systemic administration. While brilacidin resistance is less likely than for other antibiotics, I wonder if they will save the "good stuff" for the resistant cases? I would guess people would hold off on brilacidin use (just like they do now for daptomycin) for the vancomycin and methicillin resistant bacteria.
Etrade looking forward to it !!
Haha true that! Bush will def work, more of a Hobby guy myself!
Not sure if this was posted yet
http://seekingalpha.com/instablog/21116141-el...-will-blow
Hi KMBJN - Not sure if the question was directed at me but since I have been in this thread today in response to your question, the 200mg/kg mouse dosage amounts are what Cellceutix shows on their web page when it concern tumor response in lung, breast, colon and head and neck cancers, no dosage amounts are provided for the prostate and retinoblastoma studies. The questions arose from converting the mouse doses to HED by using the Baur BSA formula which is more correctly used for determining starting points for Phase I studies as opposed to direct conversions of dosages for human efficacy. I agree with "trusting Menon's expertise" and it is very evident many factors are involved in conversions. In additions these conversions are typically used for drugs that directly impact tumors by various mechanisms, so are they valid for a drug that restores P53, which in turn impacts tumors? With all the questions this process brought up I go back to the observed effects we have seen thus far, some patients having restaging/tumor arrest and multiple cycles/cohorts for multiple patients, thus a benefit was observed to those patient. That is important, (plus increased P21 expression in lymphocytes).
To end on an upbeat note tonight I wanted to pass along some interesting info regarding brilicidin. Recently Cellceutix said "B" is stable at room temp., I am not sure if that is in liquid or powder form. My daughter is a neurosurgical nurse and they routinely use Vancomyacin both in solution (mixed with saline by the nurse) and interestingly also in powder form within open incisions/surgical sites (mostly in back/neck surgeries I believe but perhaps other types of surgeries too) prophylactically. I wonder if "B" could also be used in this manner? Perhaps one of the posters who has a good history with correspondence with Leo (WildforCTIX) could pose the question if "B" can be used in powder form, just another potential use to consider.
Swish I am not sure Hooks Airports runway is long enough for this bird but Bush will work. Hahaha
Go CTIX
Looking forward to it - Hope there's room for me on there! I'm in Houston too Mata
No worries. You're on the invite list. The Cellceutix party is at my house in So Cal. Actually, the party is scheduled for the boss's house, not the dog house where I've been living for the last year and a 1/2, LOL............
Sticky worthy.
BK as a laymen I interpret your post to mean these conversions are only models and the science involved is still being studied and is not absolute
Thus this is why we have trials in humans....
It does seem we are entering the green zone for lack of a better term in two of the trials and I hope at R&R we could get more trial data on Kevetrin. I am cautiously optimistic on Leo's ability to squeeze a few items from Shapiro, but won't hold my breath
Leo has seemed very confident in the emails to other posters on the board
Here is to hoping for another week of building up the pressure on this volcano.
When we hit $100 and the CTIX members party is planned please send the NoRetreat, BK, Wild 33/33/33 owned Gulfstream IV to Houston to pick me up.
Cheers everyone
Re: equivalent doses between humans and mice, most like to use body surface area equivalence, instead of weight equivalence.
http://www.fasebj.org/content/22/3/659.full
200 mg/kg in mice * 3 = ~600 mg/m^2 dose per BSA (based on the average weight of a mouse of 20 g and body surface area of 0.007 m^2). So yes, on a strict BSA equivalence between mice and humans, 200 mg/kg is around 600 mg/m^2 (in both mice and humans).
From the article critiquing media understanding of converting mouse resveratrol doses to humans, they conclude:
"When animal studies such as those involving resveratrol are completed and media reports distort the dose translation between the study mice and the HED, misinformation regarding the effectiveness of resveratrol against a disease or condition hampers the significance of preclinical data. Understanding the more appropriate method based on BSA conversion for dose translation across species is an important issue for both the scientific community as well as the general public. Currently, BSA-based dose calculation is the most appropriate method and is far superior to the simple conversion based on body weight."
So, it's best to calculate species equivalent doses in mg/m^2 (based on body surface area) instead of mg/kg (weight equivalence), and important to compare apples to oranges.
Of course, this assumes the drug is metabolized similarly between species (similar pharmacokinetic profile) and has similar effects between species (similar pharmacodynamic profile), including the toxic effects (toxicokinetics).
There does appear to be a correlation between mouse LD10 and human MTD (http://www.ncbi.nlm.nih.gov/pubmed/8568013)
That all being said, I trust Menon's instincts on what he thinks are the relevant human doses of Kevetrin - around 100-200 kg/m^2 for efficacy without toxicity.
I would expect there to be a decent dose response curve, with higher doses of K giving better responses, so the higher we can go without dose limiting toxicities (while above the expected therapeutic range), the better.
Where did the # 200 mg/kg or ~600 mg/m^2 in mice come from again? Which cancer, which poster, etc...? Were the effective dose ranges consistent across different cancer types, different combinations of treatment, and different species?
Here's more oldest to newest. Take particular note to August 12th's PR. It's one of the last PR's where Menon comments on K.
March 8, 2013
“While our Phase 1 clinical trial is ongoing, we are planning for future trials that are aimed directly at the latest initiatives of the Food and Drug Administration to expedite development of ‘breakthrough’ technologies to commercialization,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “The data from the studies affirm that Kevetrin may be useful in a new tumor type, in addition to the other indications that we are studying. Kevetrin has delivered robust results against all indications tested to date. Cellceutix’s strategy is to have multiple trials ongoing against multiple cancer types concurrently. We are conducting testing against several more cancers to delineate the quickest path to market to build corporate and shareholder value.” - See more at: http://cellceutix.com/cellceutix-plans-for-fu...08d6M.dpuf
March 29, 2013
“We are proud to have been selected to present our research on Kevetrin to the scientific community at ASCO, especially considering the large number applicants this year,” commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “We are particularly pleased to have been selected for presenting during the high-profile General Poster Session, which allots us additional time for our abstract and extra time for a question and answer session. We receive many inquiries about Kevetrin and its progression in clinical trials and this year’s ASCO meeting provides a fantastic platform for us to share the research with our peers.” - See more at: http://cellceutix.com/cellceutix-selected-for...tjgiE.dpuf
May 28, 2013
“We will be presenting the most recent data available from the clinical trials of Kevetrin hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “We are acutely aware that the oncology community and shareholders have a strong interest regarding schedule, maximum tolerated dose and potential efficacy of Kevetrin, given its uniqueness and potential. The laboratory informed us that additional samples were required for analysis of Kevetrin’s affect on biomarker p21, an early-stage indicator of efficacy. Those samples have been supplied by the hospital with more to be delivered as the trial progresses. We are hopeful that data will be available in time for ASCO.” - See more at: http://cellceutix.com/cellceutix-to-present-p...uThfZ.dpuf
June 3, 2013
“The trial, which is currently in the fourth cohort, is progressing with data to date on par with our laboratory studies,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Through three completed cohorts, we have seen no signs of dose limiting toxicity. Dana-Farber’s extensive tumor mapping technologies will help us pinpoint which patients will benefit the most from Kevetrin as we move towards defining the Maximum Tolerated Dose. We are very pleased with the results so far and believe that as dose escalation continues, the potential therapeutic benefits will rise significantly.
Dr. Menon continued, “Some very exciting times are approaching as we expect to reach Maximum Tolerated Dose between the sixth and ninth cohorts. We also look forward to data on the p21 biomarker, which was not available for the ASCO meeting as the laboratory moves the samples into queue, in the coming weeks. As can clearly be seen in the poster, at this time ten patients have been treated with Kevetrin at low doses. Five patients have received more than one cycle of Kevetrin, including one patient who has already completed seven dosing cycles. This lends to our enthusiasm about the potential of Kevetrin and our sanguine outlook for the second half of the year.”
- See more at: http://cellceutix.com/cellceutix-presents-pos...9K26l.dpuf
June 14, 2013
“We are taking a different approach to realize some of the benefits of conducting the clinical trials of both Prurisol and Kevetrin in Europe,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “It is a similar strategy that companies like Clovis Oncology employ to follow European protocol to target a broader, yet more specific, patient population. Through a promising pipeline and efficient development model, Clovis has built an impressive valuation. In our current trials at Dana-Farber, the protocol requires that we only treat Stage IV cancer patients, which presents its own set of unique challenges that can slow research. The good news is we are likely more than half way there in terms of the trial, and we are still increasing dosage. We are very pleased with the results to date especially considering the lower doses to date. With reference to the planned University of Bologna trial, by utilizing protocol where a ‘measurable stage’ of the disease is not required for the patient, i.e., we are not limiting the trial to Stage IV patients, this should allow the trial to go much faster, and hopefully get that perfect “poster”. - See more at: http://cellceutix.com/cellceutix-updates-keve...0AC3P.dpuf
June 26, 2013
“This is another significant development in our advancement of Kevetrin. We are thrilled by the collaboration and MD Anderson’s interest in researching Kevetrin as a potential new drug for Multiple Myeloma and Lymphoma,” said Leo Ehrlich, Chief Executive Officer at Cellceutix. “Currently moving through clinical trials for solid tumors at Harvard’s Dana-Farber Cancer Center, Kevetrin being evaluated for blood cancers at MD Anderson puts our novel drug in the hands of innovative and experienced scientists at two of the most prestigious cancer research centers in the world, bar none. MD Anderson has defined a robust course of study that will provide invaluable insight to the anti-tumor activity of Kevetrin that will be used to plan for additional clinical trials as we continue to execute our strategy to aim Kevetrin at a broad spectrum of cancer lines.” - See more at: http://cellceutix.com/cellceutix-signs-materi...S9omq.dpuf
August 12, 2013
In other news, Cellceutix’s clinical trial of its anti-cancer drug Kevetrin™ is progressing and is presently in the dose escalation phase as maximum tolerated dose (MTD) has not yet been reached. The testing for p21, a biomarker study at the Harvard Cancer Center lab has not yet begun. Dr. Krishna Menon, Cellceutix’s Chief Scientific Officer commented, “We understand that there were internal priorities at the lab and because these are very sophisticated and complex tests, the process can be detailed and somewhat time consuming. We are hopeful that these important biomarker studies will soon be processed and when they are, we will share those results.” - See more at: http://cellceutix.com/cellceutix-clinical-stu...AYZjF.dpuf
A great post worth reading closely again, thanks to JB3729 for pulling it together:
Leo (CEO) on Dr. Menon (CSO) - "This Company was always built around the capabilities of Dr. Menon in developing and sourcing compounds. Dr. Menon is the bedrock of Cellceutix. Over the past three years I’ve attended many industry meetings with Dr. Menon. We’ve met with leading scientists and pharma industry executives. The feedback to me was always about the depth of knowledge and brilliance of Dr. Menon. I have never met anyone like Dr. Menon and he will continue to be the key to Cellceutix achieving its goals.”
Additionally, when a drug shows this sort of activity across a wide sampling of tumor lines in animals, it greatly increases the odds of efficacy in humans. It is for these reasons that Dr. Menon, our Chief Scientific Officer, is so excited about Kevetrin. Dr. Menon, the inventor of Kevetrin, is considered an expert in reviewing animal data and is often consulted by small and large pharma corporations and universities. Never before has he seen a drug as robust as Kevetrin against cancers. He believes that Kevetrin is outperforming other drugs he had worked on at similar points in development, which eventually became multi-billion dollar blockbusters.
I have a great deal of admiration for Dr. Menon and went back and reviewed and copied his PR statements from the Cellceutix website. If interested, Dr. Menon's escalating excitement can be captured by reading from the bottom up -
February 25, 2013 “We are excited by the advancement of the clinical trials of Kevetrin as we move toward finding the MTD (maximum tolerated dose),” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “While we are still early in the trials, we are eager to receive information on the p21 biomarker as it could represent a major breakthrough in cancer research. There has been no shortage of commentary and discussions in the scientific community recently about the latest initiatives of the U.S. Food and Drug Administration to further expedite novel drugs to market for areas of great unmet medical need. Obviously, we will be exploring this option for Kevetrin, however an application for this type of rapid movement through the regulatory process can only be made after the completion of the phase 1 clinical study.”
February 4, 2013 Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, commented, “We are still at the early stages of the clinical trial. To date, we have not observed any dose limiting toxicities. Initial pharmacokinetic (PK) data from the clinical trial has been received and is consistent with the animal data, which is a very optimistic sign moving forward. Additional information on these PK studies will be forthcoming at ASCO. We are now looking forward to receiving data from the p21 biomarker studies which is expected in March 2013.”
January 7, 2013 “Kevetrin has garnered the attention of some of the world’s foremost authorities in oncology,” commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “The University of Bologna has a distinguished history as a European leader in cancer research with a particular expertise in the field of hematological cancers. We could not be more pleased that this institution sees the potential for Kevetrin as a new drug candidate for AML and look we forward to building upon this special relationship with this esteemed institution.”
December 24, 2012 “As we stated in a press release on April 25, 2011 discussing our poster presentation at last year’s annual meeting of the American Association for Cancer Research, Kevetrin was a standout then amongst any other p53 drug in development,” added Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “Nothing has fundamentally changed since that day. In fact, the additional laboratory data that we have collected on Kevetrin, reinforces the novel drug’s ability to re-activate p53 to its role as a potent anti-proliferative and pro-apoptotic protein and holds a great deal of promise as a new therapeutic for treating cancer including some of the most difficult to treat types of the disease. The New York Times may have overlooked Cellceutix and Kevetrin, but the organizations that are contacting us to host and sponsor clinical trials certainly have not.”
December 14, 2012 “We are very encouraged with the way the Kevetrin trials are progressing,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “At this time, we are eagerly awaiting the pharmacokinetics analysis of the first dosing.”
December 3, 2012 “The clinical trials are progressing extremely well and right on schedule,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “As we await the lab reports, it’s very encouraging that we have not seen any of the toxic side effects that are commonly associated with chemotherapy at this point. Many new drugs demonstrate toxicity immediately, so I interpret the information on Kevetrin™ with a great deal of optimism. We are excited for the upcoming weeks when the next cohort, in which dosing levels will be doubled, may provide us even greater insight on what we believe is the most exciting oncologic drug in development today.”
November 8, 2012 “These advancements for a small biotech company could not have been possible without the dedication and passion our whole team demonstrated working on Kevetrin,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Kevetrin has shown in laboratory studies to activate p53, ‘the Guardian Angel Gene,’ to reduce tumor volume and slow tumor progression in cancers which other drugs were ineffective in doing so. A completely new class in chemistry, we believe that our novel drug is something that the cancer industry has been in search of for decades. We have extremely high expectations for Kevetrin.”
October 29, 2012 “We are extremely pleased to hear that the first patients will begin therapy with Kevetrin™ in a matter of days,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Not only is this is a substantial milestone for Cellceutix and its shareholders, but we feel it is important to the field of oncology. As a novel compound that directly impacts p53, the “Guardian Angel of the Human Genome,” we look forward to a steady patient enrollment and future outcomes that potentially could change the landscape of cancer therapeutics.
September 24, 2012 “This is a unique clinical trial and institutions such as Dana-Farber and Beth Israel Deaconess are extremely meticulous in their protocol. It is this level of excellence that compelled us to sponsor the trials at these clinical sites,” commented Dr. Krishna Menon, President and Chief Scientific Officer at Cellceutix.
September 10, 2012 “It seems that the potential of Kevetrin is starting to circle the globe. This University has a distinguished reputation in hematological diseases,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Our patent has been published. Only when a compound looks extremely promising do major pharmaceutical companies and universities approach a smaller company like Cellceutix. This gives us a great sense of confirmation as to the potential of Kevetrin and validation in our beliefs about the possible robust number of indications where it could provide a therapeutic benefit.”
(Marketwire – Aug 6, 2012) “To date, everything is completed and we are waiting for the host hospitals to begin dosing patients, which we anticipate will happen shortly, but it is in the hospitals’ hands at this point,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. ”Throughout my career, I have evaluated and seen many new drug candidates go from start to finish through the regulatory pathway and I am extremely optimistic and excited about the potential of Kevetrin™ because of our data collected during extensive studies and the p53 connection as the Mechanism of Action. I’m not aware of any other anti-cancer compound at this stage of development that could have such a dramatic impact in the field of oncology. Dana-Farber is one of the few hospitals in the world that collects data ‘mapping’ the human genome as related to tumor profiling and the information that will be collected from our clinical trials of Kevetrin™ could prove an invaluable asset to those suffering from cancer and to Cellceutix.”
(Marketwire – Jul 16, 2012) “We have conducted multiple meetings with companies to manufacture Prurisol™ and are aligning our strategies to advance the drug candidate into human trials as expeditiously and efficiently as possible,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. ”Our confidence is high for Prurisol™ and we are systematically deciding the best procedures going forward with it to maximize outcomes and shareholder value.”
(Marketwire – Jun 26, 2012) “In many, if not the majority, of instances, approval from the IRB and SRC can take months to receive. For us to be notified the same day as the FDA clearance that the protocol has been approved by the hospital is extremely rare and I believe that shows the commitment to commence the human trials as quickly as possible,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Everything is coming together very nicely and we will now be meeting with the host hospitals regarding the scheduling of patient enrollment and the first doses of Kevetrin™ to be administered.”
(Marketwire -06/04/12) The Cellceutix team is also pleased to report from the Annual ASCO (American Society for Clinical Oncology) Meeting, which is being held in Chicago from June 1st to June 5th, 2012. The leading industry event features clinicians, researchers and pharmaceutical companies in the cancer arena presenting their achievements, new treatments and other innovations.
“From all the materials presented, we cannot find any compound in development focused on p53 at a stage remotely comparable to Kevetrin™. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence. If any mention is given to a new compound targeting p53, we learned that they are very early in development,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “We have been in discussions with leading firms and pioneers in oncology throughout the conference. Appropriately, there is great enthusiasm surrounding vaccines and antibodies in oncology, especially the news about the experimental drugs by Bristol Myers Squibb (‘BMY’), but their limitations always surface in conversation because they have a narrow target of specific cancer lines. Researchers know that harnessing the power of p53, the ‘Guardian Angel of the Human Genome,’ can be a game changer because it is present in either ‘wild,’ ‘mutant’ or ‘null’ form in every type of cancer. Kevetrin™ is the only compound that affects all three forms, meaning that as a cancer therapy, it could have no bounds as to what cancer it treats. A drug of that prowess would represent one of the biggest breakthroughs in modern oncology and illustrates the scope and hope with Kevetrin™; explaining why it is garnering so much attention.”
“Awareness about Kevetrin™ and Cellceutix continues to grow,” commented Dr. Menon. “We are very proud of the recognition we are receiving for our company, our compounds and new cancer treatments that could potentially change the dynamics of chemotherapy as we know it today.”
“The passing of the legislation in the U.S. House of Representatives and the Senate recently, which includes a section on accelerating the review of new drugs for life-threatening diseases, has us even more eager for the commencement of clinical trials for Kevetrin™,” Dr. Menon continued. “Due to its unique Mechanism of Action to re-activate p53 in the destruction of cancer cells, we feel that this new mandate bodes especially well for us in expediting the development of this novel compound.”
(Marketwire – May 21, 2012) Dr. Krishna Menon, Chief Scientific Officer at Cellceutix commented, “I will be attending the American Society of Clinical Oncology (“ASCO”) Meeting in June to continue discussions regarding Kevetrin™. We anticipate that next year we will be presenting data from this year’s planned clinical trials.”
(Marketwire – Apr 16, 2012) Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, added, “For most developmental companies, Prurisol™ would be a lead drug candidate based on its composition, the strong research data that we have collected and the great need for a new drug for psoriasis. Our research of human xenografts in mouse models shows the type of stark differences in treatment with Prurisol™ as compared to standard treatments that are rarely demonstrated by a new drug. While we believe our flagship drug, Kevetrin™, which has attracted so much attention by showing it can re-activate p53 to destroy cancer cells, has greater market potential, Prurisol should not be underestimated as in preclinical studies it too has shown significant qualities that can make it an important drug for Cellceutix. Cellceutix is in a very fortunate position now with two breakthrough drugs in the regulatory process. By advancing Prurisol™ to this stage, we are increasing our leverage in the industry as we continue to strive to make Cellceutix the most exciting pharmaceutical company today.”
(Marketwire – Apr 4, 2012) “Many of the representatives of major pharma companies that have spoken with us previously came to visit with us and get updated on Kevetrin’s status,” said Dr. Menon. “Others seemed surprised to find a small molecule with such multi-faceted effects on cancers of various types. I was enthused to have engaged with so many bright minds from such diverse backgrounds and to have the opportunity to present our new findings on Kevetrin™ at the AACR meeting again.”
(Marketwire – Mar 12, 2012 “Prurisol is an ester of a FDA-approved drug that is used for different indications today,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Because the safety and tolerability of the active ingredient have already been determined by the FDA, we are hopeful that it will meet the requirements to advance immediately to Phase 2/3 clinical trials, saving considerable time and money. As part of our planned meeting with the FDA, we will also discuss Prurisol’s eligibility for ‘Fast Track’ review, a designation that will further expedite our efforts to bring Prurisol to market.”
(Marketwire – Jan 17, 2012) “We believe we have identified the Mechanism of Action of Kevetrin which explains why Kevetrin™ is so effective in a broad spectrum of cancers,” says Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Downregulation of HDAC2 also explains why Kevetrin™ is so effective in drug resistant tumors. Furthermore, since Kevetrin™ acts in a non-genotoxic manner and induces potent antitumor activity, we feel that Kevetrin™ is a clear standout from all other anticancer drugs. In all my years as a cancer researcher, I haven’t seen a drug act like Kevetrin™ which is targeting and reacting with virtually every type of cancer.”
(Marketwire – Jan 3, 2012) “We are very excited about 2012 as the year that we make our mark in the biotechnology world,” stated Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “The bankruptcy of Formatech, the drug formulation manufacturer for Kevetrin™, is a bit of a set-back, but the reality of drug development is that sometimes these things happen and it will only cost us a couple of months in the grand scheme of things. Ultimately, we are in an envious position with Kevetrin™ and are using the time now to move KM-133 quickly forward. Our pre-clinical data gives us confidence that we have developed the absolute best drugs that can trump all competitors for their respective indications and are confident that we will have our compounds for both drug-resistant cancers and psoriasis in human trials in 2012. Many eyes are upon us and they all want to see the stellar pre-clinical data validated with clinical trials. If the compounds produce like we think that they are going to, the value of Cellceutix should increase exponentially for our company and shareholders, making 2012 a banner year.”
(Marketwire – Oct 3, 2011) Cellceutix Chief Scientific Officer Dr. Krishna Menon said, “Each research center has its own drug delivery device that must be tested with a new drug to ensure stability, according to FDA protocol.” Dr. Menon continued, “It has been an extremely gratifying process working with Kevetrin™ and we are close to beginning the process of validating our contentions about the potency of our drug. The drug in studies to date has proven to be a major leap forward in the fight against cancer. We have reviewed our research on Kevetrin™ with the hospital, major pharmaceutical companies and some of the brightest minds in oncology today with very encouraging responses. As professionals, we are expected to remain subdued, but, honestly, it is a bit difficult as Kevetrin™ is showing characteristics that could make it one of the most innovative drugs in cancer research."
(Marketwire – Jun 20, 2011) “Kevetrin™ simply continues to impress,” stated Dr. Krishna Menon, CSO of Cellceutix. “In reality, the nearly 100% tumor growth delay was underestimated as the tumors in one of the Kevetrin treated mice never reached 500mm3. Therefore, it had to be omitted from that set of data; otherwise the figure would have been even higher. Preliminary data from the second cycle of dosing, initiated when tumors had reached 2200mm3, is again showing reduction of tumor growth, reinforcing the idea of no resistance towards Kevetrin™ developing and the sheer potency of our compound. In all my years as a researcher, I have never seen anything like Kevetrin™.”
(Marketwire – May 16, 2011) Dr. Krishna Menon, Chief Scientific Officer of Cellceutix, commented, “Our research to date has shown the potential of Kevetrin™ as a stand-alone therapy. This additional data demonstrates its value as a combination therapy. We believe the radiosensitizer capacity of Kevetrin™ is once again attributable to its interaction with p53. The data that we have collected in our pre-clinical studies on Kevetrin™ gives me great hope that Cellceutix is developing a drug that one day will have a major impact on cancer treatments.”
(Marketwire – February 28, 2011) – Cellceutix Corporation (PINKSHEETS: CTIX) announced today that data from research on Kevetrin™, the Company’s flagship compound against cancers, has demonstrated the potential for a major breakthrough in cancer research by exhibiting an activation of p53.
http://cellceutix.com/cellceutix-makes-breakt...-genome-2/
(Marketwire – October 28, 2010) “This is the last safety study we had to complete prior to IND filing and we are extremely pleased with the results,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “Having now seen the data from all the required studies, I am very excited about the future of this compound in development for cancers that are resistant to standard therapies.”
(Marketwire – September 28, 2010) “We are now completing a similar study in the second tier of animals as required by the FDA,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”At Cellceutix we are very excited about the progression of Kevetrin as we are right on course with our business plan to develop it as a treatment for cancers that are resistant to standard therapies.”
(Marketwire – August 24, 2010) “I have been closely involved in the development of several successful compounds in my 30 years in the industry and am extremely encouraged by the data that Kevetrin has produced,” stated Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”The completion of pre-clinical studies creates a great deal of excitement for our team as we are anxious to see Kevetrin being utilized as a human therapy in the near future.”
(Marketwire – July 7, 2010) Dr. Krishna Menon, Chief Scientific Officer of Cellceutix commenting on the results, stated, “Previous required testing on the respiratory and central nervous systems showed no significant neuropharmacological or biologically relevant effects. This set of cardiovascular testing coincided with those results with no significant effects at low, medium or high dosage levels. While there was a transient increase in heart rate at extreme dosage levels, we do not believe it will be of any significance going forward as even the highest dosages had no toxicological effects on ECG or cardiac rhythm.” Dr. Menon continued, “The completion of animal safety pharmacology studies presents a big milestone for Cellceutix. The remaining toxicology data necessary for preparing our IND should be received by late July.”
(Marketwire – June 21, 2010) “The G2/M portion of a cancer cell’s cycle is critical as it the stage before a cell enters mitosis, the time when the cell divides into 2 identical nuclei. Kevetrin is proving once again to slow or stop the growth of carcinoma cells,” stated Cellceutix Chief Scientific Officer Dr. Krishna Menon. ”The increased apoptosis is very significant because it shows that the cancer cells are being destroyed without damaging any of the healthy cells around it.”
(Marketwire – June 14, 2010) “We are extremely excited about the results from this phase of testing as it coincides with the previous research,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”Having been involved in the research and development of extremely successful compounds in the past, I am very encouraged by the research results that we are achieving with KM-391 and its development potential as a treatment for autism. In our testing, we have simulated specific characteristics of an autistic brain and behavioral symptoms that result from them. KM-391 has been shown to significantly improve both the physical conditions in the brain and behaviors resulting in our animal models. We now have a basis to expect to emerge as a pharma industry leader in autism.”
(Marketwire – June 7, 2010) “The results of these studies are very encouraging for the further development of Kevetrin,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”The respiratory and central nervous system studies showed no biologically significant changes compared to controls. Since these studies are required by the FDA for an IND filing, their completion is a major forward step for us.”
(Marketwire – May 18, 2010) “The animal data on Kevetrin have consistently shown strong activity against drug resistant cancer cell lines,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “We are continuing to make solid progress toward our IND filing, which would be a major milestone for us.”
(Marketwire – April 21, 2010) “These data are another important piece of the Kevetrin story,” said its Chief Scientific Officer, Dr. Krishna Menon. ”The continued and undiminished anti-tumor effect when a second cycle is administered is particularly significant, showing that resistance to Kevetrin is not developing.”
(Marketwire – March 29, 2010) “Research on autism has been difficult because there has been no reliable animal model,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”Fortunately, we were able to tap into some cutting edge research to find a promising model for our study.”
(Marketwire – March 22, 2010) Not attributed to DR. Menon, but, significant - Kevetrin is being developed to treat drug resistant cancers. The Company has recently reported that Kevetrin showed greater tumor shrinkage than standard therapies in animal models of resistant lung cancer, breast and colon cancer cell lines.
(Marketwire – March 15, 2010) “This is a significant event for Cellceutix,” said its Chief Scientific Officer, Dr. Krishna Menon. “The AACR is the premier cancer research organization and its annual meeting attracts scientists and pharma executives throughout the world. We are pleased to be able to present our data at the upcoming meeting.”
Not criticizing you by any means but it. Was just ten eleven twelve that emailed df for a friend in Pennsylvania that found out about wait list. Was confirmed by your cited email and a poster on a. Breast cancer board.
Tomorrow market is open and we can get back to business of share price. Thank goodness
Gov
Check asco it was ten eom gov
That guest should be careful for what they wish for...... We are on borrowed time here in FL, eight years without a direct hit, at some point that will change. While weather is fascinating, no desire to see a Cat 2 or higher up close, I would be long gone before that if I lived right on the coast and in the storm surge zone....
I did not mean to say in absolutes. I was simply trying to point out the significance of multiple cycles. Dr. Jorgensen also stressed this point at Biotech Showcase.
Quote:
There are so many factors at play that it is ridiculous at this point to speak in absolutes.
Actually there is a waiting list for the Kevetrin trial. A poster here called DF and was told about the waiting list. Dr. Menon also said he does not expect a shortage of patients. Of course not everyone qualifies. Karen’s friend is an example.
Quote:
If things were so black and white there would be many more patients lining up for Kevetrin and many more investors as well, which there aren't.
As one guest put it, I paid for a full hurricane and this is all I got?
Big Island didn't fair as well as Oahu. Sadly, the occupants of a car perished trying to reach safety crossing a storm swollen stream.
Quote:
BK I hope you faired well in the recent storms in Hawaii,
Good Luck and GOD Bless......BUT pleeeeeease...enough already...
http://www.youtube.com/watch?v=d8cpkwPAbY0
GIDDDDDDDY UP & GOOOOOOOOOOOOOOOOOOOOOOO CTIX !
I am pretty sure the K trial starting dosage was 10mg/m2, not 15mg/kg
Thanks RJFL, I see the 200 mg/kg mouse doses on CTIX web site, and now looking back at the Kumar 2012 AACR poster, that in A549 lung carcinoma studies, 50 mg/kg Kevetrin was indistinguishable from controls, 100 mg/kg was better, 200 mg/kg better, and 2 cycles of 200 mg/kg best at delaying tumor growth.
I'm not really sure how to best scale these doses to humans, but scaling based on BSA seems like a good start. Of course the PK/PD differences between mice and humans matter greatly too. I'm sure the CTIX scientists have their models.
There was a nice point / counterpoint discussion of using BSA to dose cancer drugs (more for individual human dosage, not prediction of HED based on preclinical work):
http://www.nature.com/clpt/journal/v95/n4/abs...1412a.html
http://www.nature.com/clpt/journal/v95/n4/abs...0147a.html
"The historical rationale for using BSA-based dosing was to provide an allometric parameter for scaling dose determined in animals to humans, but that is not a sufficient argument to justify its use. Indeed, scaling has been used to determine the first level of dose of the first-in-human phase I study (usually 1/10 of the Lethal Dose 10)"
So if scaling animal to human BSA is not a good model for estimating efficacy equivalence (but only for starting dose), what is a better model?
I guess just use the animal data to estimate a safe starting point, then use the clinical trial data to determine efficacy and safety data? Maybe there are just too many variables for the simple BSA scaling to be useful, but I'd like to know what is a better general model.
Interesting idea about brilacidin for surgical prophylaxis. I work in the OR during many neurosurgical procedures, and IV antibiotics are usually given by the anesthesiologist / nurse anesthetist at the start of the case. I haven't seen powder form being used much. One of the orthopedic spine surgeons uses lots of antibiotic irrigation before closing, and has low infection rates, so maybe local wound application is a good idea in addition to systemic administration. While brilacidin resistance is less likely than for other antibiotics, I wonder if they will save the "good stuff" for the resistant cases? I would guess people would hold off on brilacidin use (just like they do now for daptomycin) for the vancomycin and methicillin resistant bacteria.
Etrade looking forward to it !!
Haha true that! Bush will def work, more of a Hobby guy myself!
Not sure if this was posted yet
http://seekingalpha.com/instablog/21116141-el...-will-blow
Hi KMBJN - Not sure if the question was directed at me but since I have been in this thread today in response to your question, the 200mg/kg mouse dosage amounts are what Cellceutix shows on their web page when it concern tumor response in lung, breast, colon and head and neck cancers, no dosage amounts are provided for the prostate and retinoblastoma studies. The questions arose from converting the mouse doses to HED by using the Baur BSA formula which is more correctly used for determining starting points for Phase I studies as opposed to direct conversions of dosages for human efficacy. I agree with "trusting Menon's expertise" and it is very evident many factors are involved in conversions. In additions these conversions are typically used for drugs that directly impact tumors by various mechanisms, so are they valid for a drug that restores P53, which in turn impacts tumors? With all the questions this process brought up I go back to the observed effects we have seen thus far, some patients having restaging/tumor arrest and multiple cycles/cohorts for multiple patients, thus a benefit was observed to those patient. That is important, (plus increased P21 expression in lymphocytes).
To end on an upbeat note tonight I wanted to pass along some interesting info regarding brilicidin. Recently Cellceutix said "B" is stable at room temp., I am not sure if that is in liquid or powder form. My daughter is a neurosurgical nurse and they routinely use Vancomyacin both in solution (mixed with saline by the nurse) and interestingly also in powder form within open incisions/surgical sites (mostly in back/neck surgeries I believe but perhaps other types of surgeries too) prophylactically. I wonder if "B" could also be used in this manner? Perhaps one of the posters who has a good history with correspondence with Leo (WildforCTIX) could pose the question if "B" can be used in powder form, just another potential use to consider.
Swish I am not sure Hooks Airports runway is long enough for this bird but Bush will work. Hahaha
Go CTIX
Looking forward to it - Hope there's room for me on there! I'm in Houston too Mata
No worries. You're on the invite list. The Cellceutix party is at my house in So Cal. Actually, the party is scheduled for the boss's house, not the dog house where I've been living for the last year and a 1/2, LOL............
Sticky worthy.
BK as a laymen I interpret your post to mean these conversions are only models and the science involved is still being studied and is not absolute
Thus this is why we have trials in humans....
It does seem we are entering the green zone for lack of a better term in two of the trials and I hope at R&R we could get more trial data on Kevetrin. I am cautiously optimistic on Leo's ability to squeeze a few items from Shapiro, but won't hold my breath
Leo has seemed very confident in the emails to other posters on the board
Here is to hoping for another week of building up the pressure on this volcano.
When we hit $100 and the CTIX members party is planned please send the NoRetreat, BK, Wild 33/33/33 owned Gulfstream IV to Houston to pick me up.
Cheers everyone
Re: equivalent doses between humans and mice, most like to use body surface area equivalence, instead of weight equivalence.
http://www.fasebj.org/content/22/3/659.full
200 mg/kg in mice * 3 = ~600 mg/m^2 dose per BSA (based on the average weight of a mouse of 20 g and body surface area of 0.007 m^2). So yes, on a strict BSA equivalence between mice and humans, 200 mg/kg is around 600 mg/m^2 (in both mice and humans).
From the article critiquing media understanding of converting mouse resveratrol doses to humans, they conclude:
"When animal studies such as those involving resveratrol are completed and media reports distort the dose translation between the study mice and the HED, misinformation regarding the effectiveness of resveratrol against a disease or condition hampers the significance of preclinical data. Understanding the more appropriate method based on BSA conversion for dose translation across species is an important issue for both the scientific community as well as the general public. Currently, BSA-based dose calculation is the most appropriate method and is far superior to the simple conversion based on body weight."
So, it's best to calculate species equivalent doses in mg/m^2 (based on body surface area) instead of mg/kg (weight equivalence), and important to compare apples to oranges.
Of course, this assumes the drug is metabolized similarly between species (similar pharmacokinetic profile) and has similar effects between species (similar pharmacodynamic profile), including the toxic effects (toxicokinetics).
There does appear to be a correlation between mouse LD10 and human MTD (http://www.ncbi.nlm.nih.gov/pubmed/8568013)
That all being said, I trust Menon's instincts on what he thinks are the relevant human doses of Kevetrin - around 100-200 kg/m^2 for efficacy without toxicity.
I would expect there to be a decent dose response curve, with higher doses of K giving better responses, so the higher we can go without dose limiting toxicities (while above the expected therapeutic range), the better.
Where did the # 200 mg/kg or ~600 mg/m^2 in mice come from again? Which cancer, which poster, etc...? Were the effective dose ranges consistent across different cancer types, different combinations of treatment, and different species?
Here's more oldest to newest. Take particular note to August 12th's PR. It's one of the last PR's where Menon comments on K.
March 8, 2013
“While our Phase 1 clinical trial is ongoing, we are planning for future trials that are aimed directly at the latest initiatives of the Food and Drug Administration to expedite development of ‘breakthrough’ technologies to commercialization,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “The data from the studies affirm that Kevetrin may be useful in a new tumor type, in addition to the other indications that we are studying. Kevetrin has delivered robust results against all indications tested to date. Cellceutix’s strategy is to have multiple trials ongoing against multiple cancer types concurrently. We are conducting testing against several more cancers to delineate the quickest path to market to build corporate and shareholder value.” - See more at: http://cellceutix.com/cellceutix-plans-for-fu...08d6M.dpuf
March 29, 2013
“We are proud to have been selected to present our research on Kevetrin to the scientific community at ASCO, especially considering the large number applicants this year,” commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “We are particularly pleased to have been selected for presenting during the high-profile General Poster Session, which allots us additional time for our abstract and extra time for a question and answer session. We receive many inquiries about Kevetrin and its progression in clinical trials and this year’s ASCO meeting provides a fantastic platform for us to share the research with our peers.” - See more at: http://cellceutix.com/cellceutix-selected-for...tjgiE.dpuf
May 28, 2013
“We will be presenting the most recent data available from the clinical trials of Kevetrin hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “We are acutely aware that the oncology community and shareholders have a strong interest regarding schedule, maximum tolerated dose and potential efficacy of Kevetrin, given its uniqueness and potential. The laboratory informed us that additional samples were required for analysis of Kevetrin’s affect on biomarker p21, an early-stage indicator of efficacy. Those samples have been supplied by the hospital with more to be delivered as the trial progresses. We are hopeful that data will be available in time for ASCO.” - See more at: http://cellceutix.com/cellceutix-to-present-p...uThfZ.dpuf
June 3, 2013
“The trial, which is currently in the fourth cohort, is progressing with data to date on par with our laboratory studies,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Through three completed cohorts, we have seen no signs of dose limiting toxicity. Dana-Farber’s extensive tumor mapping technologies will help us pinpoint which patients will benefit the most from Kevetrin as we move towards defining the Maximum Tolerated Dose. We are very pleased with the results so far and believe that as dose escalation continues, the potential therapeutic benefits will rise significantly.
Dr. Menon continued, “Some very exciting times are approaching as we expect to reach Maximum Tolerated Dose between the sixth and ninth cohorts. We also look forward to data on the p21 biomarker, which was not available for the ASCO meeting as the laboratory moves the samples into queue, in the coming weeks. As can clearly be seen in the poster, at this time ten patients have been treated with Kevetrin at low doses. Five patients have received more than one cycle of Kevetrin, including one patient who has already completed seven dosing cycles. This lends to our enthusiasm about the potential of Kevetrin and our sanguine outlook for the second half of the year.”
- See more at: http://cellceutix.com/cellceutix-presents-pos...9K26l.dpuf
June 14, 2013
“We are taking a different approach to realize some of the benefits of conducting the clinical trials of both Prurisol and Kevetrin in Europe,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “It is a similar strategy that companies like Clovis Oncology employ to follow European protocol to target a broader, yet more specific, patient population. Through a promising pipeline and efficient development model, Clovis has built an impressive valuation. In our current trials at Dana-Farber, the protocol requires that we only treat Stage IV cancer patients, which presents its own set of unique challenges that can slow research. The good news is we are likely more than half way there in terms of the trial, and we are still increasing dosage. We are very pleased with the results to date especially considering the lower doses to date. With reference to the planned University of Bologna trial, by utilizing protocol where a ‘measurable stage’ of the disease is not required for the patient, i.e., we are not limiting the trial to Stage IV patients, this should allow the trial to go much faster, and hopefully get that perfect “poster”. - See more at: http://cellceutix.com/cellceutix-updates-keve...0AC3P.dpuf
June 26, 2013
“This is another significant development in our advancement of Kevetrin. We are thrilled by the collaboration and MD Anderson’s interest in researching Kevetrin as a potential new drug for Multiple Myeloma and Lymphoma,” said Leo Ehrlich, Chief Executive Officer at Cellceutix. “Currently moving through clinical trials for solid tumors at Harvard’s Dana-Farber Cancer Center, Kevetrin being evaluated for blood cancers at MD Anderson puts our novel drug in the hands of innovative and experienced scientists at two of the most prestigious cancer research centers in the world, bar none. MD Anderson has defined a robust course of study that will provide invaluable insight to the anti-tumor activity of Kevetrin that will be used to plan for additional clinical trials as we continue to execute our strategy to aim Kevetrin at a broad spectrum of cancer lines.” - See more at: http://cellceutix.com/cellceutix-signs-materi...S9omq.dpuf
August 12, 2013
In other news, Cellceutix’s clinical trial of its anti-cancer drug Kevetrin™ is progressing and is presently in the dose escalation phase as maximum tolerated dose (MTD) has not yet been reached. The testing for p21, a biomarker study at the Harvard Cancer Center lab has not yet begun. Dr. Krishna Menon, Cellceutix’s Chief Scientific Officer commented, “We understand that there were internal priorities at the lab and because these are very sophisticated and complex tests, the process can be detailed and somewhat time consuming. We are hopeful that these important biomarker studies will soon be processed and when they are, we will share those results.” - See more at: http://cellceutix.com/cellceutix-clinical-stu...AYZjF.dpuf
A great post worth reading closely again, thanks to JB3729 for pulling it together:
Leo (CEO) on Dr. Menon (CSO) - "This Company was always built around the capabilities of Dr. Menon in developing and sourcing compounds. Dr. Menon is the bedrock of Cellceutix. Over the past three years I’ve attended many industry meetings with Dr. Menon. We’ve met with leading scientists and pharma industry executives. The feedback to me was always about the depth of knowledge and brilliance of Dr. Menon. I have never met anyone like Dr. Menon and he will continue to be the key to Cellceutix achieving its goals.”
Additionally, when a drug shows this sort of activity across a wide sampling of tumor lines in animals, it greatly increases the odds of efficacy in humans. It is for these reasons that Dr. Menon, our Chief Scientific Officer, is so excited about Kevetrin. Dr. Menon, the inventor of Kevetrin, is considered an expert in reviewing animal data and is often consulted by small and large pharma corporations and universities. Never before has he seen a drug as robust as Kevetrin against cancers. He believes that Kevetrin is outperforming other drugs he had worked on at similar points in development, which eventually became multi-billion dollar blockbusters.
I have a great deal of admiration for Dr. Menon and went back and reviewed and copied his PR statements from the Cellceutix website. If interested, Dr. Menon's escalating excitement can be captured by reading from the bottom up -
February 25, 2013 “We are excited by the advancement of the clinical trials of Kevetrin as we move toward finding the MTD (maximum tolerated dose),” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “While we are still early in the trials, we are eager to receive information on the p21 biomarker as it could represent a major breakthrough in cancer research. There has been no shortage of commentary and discussions in the scientific community recently about the latest initiatives of the U.S. Food and Drug Administration to further expedite novel drugs to market for areas of great unmet medical need. Obviously, we will be exploring this option for Kevetrin, however an application for this type of rapid movement through the regulatory process can only be made after the completion of the phase 1 clinical study.”
February 4, 2013 Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, commented, “We are still at the early stages of the clinical trial. To date, we have not observed any dose limiting toxicities. Initial pharmacokinetic (PK) data from the clinical trial has been received and is consistent with the animal data, which is a very optimistic sign moving forward. Additional information on these PK studies will be forthcoming at ASCO. We are now looking forward to receiving data from the p21 biomarker studies which is expected in March 2013.”
January 7, 2013 “Kevetrin has garnered the attention of some of the world’s foremost authorities in oncology,” commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “The University of Bologna has a distinguished history as a European leader in cancer research with a particular expertise in the field of hematological cancers. We could not be more pleased that this institution sees the potential for Kevetrin as a new drug candidate for AML and look we forward to building upon this special relationship with this esteemed institution.”
December 24, 2012 “As we stated in a press release on April 25, 2011 discussing our poster presentation at last year’s annual meeting of the American Association for Cancer Research, Kevetrin was a standout then amongst any other p53 drug in development,” added Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “Nothing has fundamentally changed since that day. In fact, the additional laboratory data that we have collected on Kevetrin, reinforces the novel drug’s ability to re-activate p53 to its role as a potent anti-proliferative and pro-apoptotic protein and holds a great deal of promise as a new therapeutic for treating cancer including some of the most difficult to treat types of the disease. The New York Times may have overlooked Cellceutix and Kevetrin, but the organizations that are contacting us to host and sponsor clinical trials certainly have not.”
December 14, 2012 “We are very encouraged with the way the Kevetrin trials are progressing,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “At this time, we are eagerly awaiting the pharmacokinetics analysis of the first dosing.”
December 3, 2012 “The clinical trials are progressing extremely well and right on schedule,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “As we await the lab reports, it’s very encouraging that we have not seen any of the toxic side effects that are commonly associated with chemotherapy at this point. Many new drugs demonstrate toxicity immediately, so I interpret the information on Kevetrin™ with a great deal of optimism. We are excited for the upcoming weeks when the next cohort, in which dosing levels will be doubled, may provide us even greater insight on what we believe is the most exciting oncologic drug in development today.”
November 8, 2012 “These advancements for a small biotech company could not have been possible without the dedication and passion our whole team demonstrated working on Kevetrin,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Kevetrin has shown in laboratory studies to activate p53, ‘the Guardian Angel Gene,’ to reduce tumor volume and slow tumor progression in cancers which other drugs were ineffective in doing so. A completely new class in chemistry, we believe that our novel drug is something that the cancer industry has been in search of for decades. We have extremely high expectations for Kevetrin.”
October 29, 2012 “We are extremely pleased to hear that the first patients will begin therapy with Kevetrin™ in a matter of days,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Not only is this is a substantial milestone for Cellceutix and its shareholders, but we feel it is important to the field of oncology. As a novel compound that directly impacts p53, the “Guardian Angel of the Human Genome,” we look forward to a steady patient enrollment and future outcomes that potentially could change the landscape of cancer therapeutics.
September 24, 2012 “This is a unique clinical trial and institutions such as Dana-Farber and Beth Israel Deaconess are extremely meticulous in their protocol. It is this level of excellence that compelled us to sponsor the trials at these clinical sites,” commented Dr. Krishna Menon, President and Chief Scientific Officer at Cellceutix.
September 10, 2012 “It seems that the potential of Kevetrin is starting to circle the globe. This University has a distinguished reputation in hematological diseases,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Our patent has been published. Only when a compound looks extremely promising do major pharmaceutical companies and universities approach a smaller company like Cellceutix. This gives us a great sense of confirmation as to the potential of Kevetrin and validation in our beliefs about the possible robust number of indications where it could provide a therapeutic benefit.”
(Marketwire – Aug 6, 2012) “To date, everything is completed and we are waiting for the host hospitals to begin dosing patients, which we anticipate will happen shortly, but it is in the hospitals’ hands at this point,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. ”Throughout my career, I have evaluated and seen many new drug candidates go from start to finish through the regulatory pathway and I am extremely optimistic and excited about the potential of Kevetrin™ because of our data collected during extensive studies and the p53 connection as the Mechanism of Action. I’m not aware of any other anti-cancer compound at this stage of development that could have such a dramatic impact in the field of oncology. Dana-Farber is one of the few hospitals in the world that collects data ‘mapping’ the human genome as related to tumor profiling and the information that will be collected from our clinical trials of Kevetrin™ could prove an invaluable asset to those suffering from cancer and to Cellceutix.”
(Marketwire – Jul 16, 2012) “We have conducted multiple meetings with companies to manufacture Prurisol™ and are aligning our strategies to advance the drug candidate into human trials as expeditiously and efficiently as possible,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. ”Our confidence is high for Prurisol™ and we are systematically deciding the best procedures going forward with it to maximize outcomes and shareholder value.”
(Marketwire – Jun 26, 2012) “In many, if not the majority, of instances, approval from the IRB and SRC can take months to receive. For us to be notified the same day as the FDA clearance that the protocol has been approved by the hospital is extremely rare and I believe that shows the commitment to commence the human trials as quickly as possible,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Everything is coming together very nicely and we will now be meeting with the host hospitals regarding the scheduling of patient enrollment and the first doses of Kevetrin™ to be administered.”
(Marketwire -06/04/12) The Cellceutix team is also pleased to report from the Annual ASCO (American Society for Clinical Oncology) Meeting, which is being held in Chicago from June 1st to June 5th, 2012. The leading industry event features clinicians, researchers and pharmaceutical companies in the cancer arena presenting their achievements, new treatments and other innovations.
“From all the materials presented, we cannot find any compound in development focused on p53 at a stage remotely comparable to Kevetrin™. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence. If any mention is given to a new compound targeting p53, we learned that they are very early in development,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “We have been in discussions with leading firms and pioneers in oncology throughout the conference. Appropriately, there is great enthusiasm surrounding vaccines and antibodies in oncology, especially the news about the experimental drugs by Bristol Myers Squibb (‘BMY’), but their limitations always surface in conversation because they have a narrow target of specific cancer lines. Researchers know that harnessing the power of p53, the ‘Guardian Angel of the Human Genome,’ can be a game changer because it is present in either ‘wild,’ ‘mutant’ or ‘null’ form in every type of cancer. Kevetrin™ is the only compound that affects all three forms, meaning that as a cancer therapy, it could have no bounds as to what cancer it treats. A drug of that prowess would represent one of the biggest breakthroughs in modern oncology and illustrates the scope and hope with Kevetrin™; explaining why it is garnering so much attention.”
“Awareness about Kevetrin™ and Cellceutix continues to grow,” commented Dr. Menon. “We are very proud of the recognition we are receiving for our company, our compounds and new cancer treatments that could potentially change the dynamics of chemotherapy as we know it today.”
“The passing of the legislation in the U.S. House of Representatives and the Senate recently, which includes a section on accelerating the review of new drugs for life-threatening diseases, has us even more eager for the commencement of clinical trials for Kevetrin™,” Dr. Menon continued. “Due to its unique Mechanism of Action to re-activate p53 in the destruction of cancer cells, we feel that this new mandate bodes especially well for us in expediting the development of this novel compound.”
(Marketwire – May 21, 2012) Dr. Krishna Menon, Chief Scientific Officer at Cellceutix commented, “I will be attending the American Society of Clinical Oncology (“ASCO”) Meeting in June to continue discussions regarding Kevetrin™. We anticipate that next year we will be presenting data from this year’s planned clinical trials.”
(Marketwire – Apr 16, 2012) Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, added, “For most developmental companies, Prurisol™ would be a lead drug candidate based on its composition, the strong research data that we have collected and the great need for a new drug for psoriasis. Our research of human xenografts in mouse models shows the type of stark differences in treatment with Prurisol™ as compared to standard treatments that are rarely demonstrated by a new drug. While we believe our flagship drug, Kevetrin™, which has attracted so much attention by showing it can re-activate p53 to destroy cancer cells, has greater market potential, Prurisol should not be underestimated as in preclinical studies it too has shown significant qualities that can make it an important drug for Cellceutix. Cellceutix is in a very fortunate position now with two breakthrough drugs in the regulatory process. By advancing Prurisol™ to this stage, we are increasing our leverage in the industry as we continue to strive to make Cellceutix the most exciting pharmaceutical company today.”
(Marketwire – Apr 4, 2012) “Many of the representatives of major pharma companies that have spoken with us previously came to visit with us and get updated on Kevetrin’s status,” said Dr. Menon. “Others seemed surprised to find a small molecule with such multi-faceted effects on cancers of various types. I was enthused to have engaged with so many bright minds from such diverse backgrounds and to have the opportunity to present our new findings on Kevetrin™ at the AACR meeting again.”
(Marketwire – Mar 12, 2012 “Prurisol is an ester of a FDA-approved drug that is used for different indications today,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Because the safety and tolerability of the active ingredient have already been determined by the FDA, we are hopeful that it will meet the requirements to advance immediately to Phase 2/3 clinical trials, saving considerable time and money. As part of our planned meeting with the FDA, we will also discuss Prurisol’s eligibility for ‘Fast Track’ review, a designation that will further expedite our efforts to bring Prurisol to market.”
(Marketwire – Jan 17, 2012) “We believe we have identified the Mechanism of Action of Kevetrin which explains why Kevetrin™ is so effective in a broad spectrum of cancers,” says Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Downregulation of HDAC2 also explains why Kevetrin™ is so effective in drug resistant tumors. Furthermore, since Kevetrin™ acts in a non-genotoxic manner and induces potent antitumor activity, we feel that Kevetrin™ is a clear standout from all other anticancer drugs. In all my years as a cancer researcher, I haven’t seen a drug act like Kevetrin™ which is targeting and reacting with virtually every type of cancer.”
(Marketwire – Jan 3, 2012) “We are very excited about 2012 as the year that we make our mark in the biotechnology world,” stated Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “The bankruptcy of Formatech, the drug formulation manufacturer for Kevetrin™, is a bit of a set-back, but the reality of drug development is that sometimes these things happen and it will only cost us a couple of months in the grand scheme of things. Ultimately, we are in an envious position with Kevetrin™ and are using the time now to move KM-133 quickly forward. Our pre-clinical data gives us confidence that we have developed the absolute best drugs that can trump all competitors for their respective indications and are confident that we will have our compounds for both drug-resistant cancers and psoriasis in human trials in 2012. Many eyes are upon us and they all want to see the stellar pre-clinical data validated with clinical trials. If the compounds produce like we think that they are going to, the value of Cellceutix should increase exponentially for our company and shareholders, making 2012 a banner year.”
(Marketwire – Oct 3, 2011) Cellceutix Chief Scientific Officer Dr. Krishna Menon said, “Each research center has its own drug delivery device that must be tested with a new drug to ensure stability, according to FDA protocol.” Dr. Menon continued, “It has been an extremely gratifying process working with Kevetrin™ and we are close to beginning the process of validating our contentions about the potency of our drug. The drug in studies to date has proven to be a major leap forward in the fight against cancer. We have reviewed our research on Kevetrin™ with the hospital, major pharmaceutical companies and some of the brightest minds in oncology today with very encouraging responses. As professionals, we are expected to remain subdued, but, honestly, it is a bit difficult as Kevetrin™ is showing characteristics that could make it one of the most innovative drugs in cancer research."
(Marketwire – Jun 20, 2011) “Kevetrin™ simply continues to impress,” stated Dr. Krishna Menon, CSO of Cellceutix. “In reality, the nearly 100% tumor growth delay was underestimated as the tumors in one of the Kevetrin treated mice never reached 500mm3. Therefore, it had to be omitted from that set of data; otherwise the figure would have been even higher. Preliminary data from the second cycle of dosing, initiated when tumors had reached 2200mm3, is again showing reduction of tumor growth, reinforcing the idea of no resistance towards Kevetrin™ developing and the sheer potency of our compound. In all my years as a researcher, I have never seen anything like Kevetrin™.”
(Marketwire – May 16, 2011) Dr. Krishna Menon, Chief Scientific Officer of Cellceutix, commented, “Our research to date has shown the potential of Kevetrin™ as a stand-alone therapy. This additional data demonstrates its value as a combination therapy. We believe the radiosensitizer capacity of Kevetrin™ is once again attributable to its interaction with p53. The data that we have collected in our pre-clinical studies on Kevetrin™ gives me great hope that Cellceutix is developing a drug that one day will have a major impact on cancer treatments.”
(Marketwire – February 28, 2011) – Cellceutix Corporation (PINKSHEETS: CTIX) announced today that data from research on Kevetrin™, the Company’s flagship compound against cancers, has demonstrated the potential for a major breakthrough in cancer research by exhibiting an activation of p53.
http://cellceutix.com/cellceutix-makes-breakt...-genome-2/
(Marketwire – October 28, 2010) “This is the last safety study we had to complete prior to IND filing and we are extremely pleased with the results,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “Having now seen the data from all the required studies, I am very excited about the future of this compound in development for cancers that are resistant to standard therapies.”
(Marketwire – September 28, 2010) “We are now completing a similar study in the second tier of animals as required by the FDA,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”At Cellceutix we are very excited about the progression of Kevetrin as we are right on course with our business plan to develop it as a treatment for cancers that are resistant to standard therapies.”
(Marketwire – August 24, 2010) “I have been closely involved in the development of several successful compounds in my 30 years in the industry and am extremely encouraged by the data that Kevetrin has produced,” stated Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”The completion of pre-clinical studies creates a great deal of excitement for our team as we are anxious to see Kevetrin being utilized as a human therapy in the near future.”
(Marketwire – July 7, 2010) Dr. Krishna Menon, Chief Scientific Officer of Cellceutix commenting on the results, stated, “Previous required testing on the respiratory and central nervous systems showed no significant neuropharmacological or biologically relevant effects. This set of cardiovascular testing coincided with those results with no significant effects at low, medium or high dosage levels. While there was a transient increase in heart rate at extreme dosage levels, we do not believe it will be of any significance going forward as even the highest dosages had no toxicological effects on ECG or cardiac rhythm.” Dr. Menon continued, “The completion of animal safety pharmacology studies presents a big milestone for Cellceutix. The remaining toxicology data necessary for preparing our IND should be received by late July.”
(Marketwire – June 21, 2010) “The G2/M portion of a cancer cell’s cycle is critical as it the stage before a cell enters mitosis, the time when the cell divides into 2 identical nuclei. Kevetrin is proving once again to slow or stop the growth of carcinoma cells,” stated Cellceutix Chief Scientific Officer Dr. Krishna Menon. ”The increased apoptosis is very significant because it shows that the cancer cells are being destroyed without damaging any of the healthy cells around it.”
(Marketwire – June 14, 2010) “We are extremely excited about the results from this phase of testing as it coincides with the previous research,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”Having been involved in the research and development of extremely successful compounds in the past, I am very encouraged by the research results that we are achieving with KM-391 and its development potential as a treatment for autism. In our testing, we have simulated specific characteristics of an autistic brain and behavioral symptoms that result from them. KM-391 has been shown to significantly improve both the physical conditions in the brain and behaviors resulting in our animal models. We now have a basis to expect to emerge as a pharma industry leader in autism.”
(Marketwire – June 7, 2010) “The results of these studies are very encouraging for the further development of Kevetrin,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”The respiratory and central nervous system studies showed no biologically significant changes compared to controls. Since these studies are required by the FDA for an IND filing, their completion is a major forward step for us.”
(Marketwire – May 18, 2010) “The animal data on Kevetrin have consistently shown strong activity against drug resistant cancer cell lines,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “We are continuing to make solid progress toward our IND filing, which would be a major milestone for us.”
(Marketwire – April 21, 2010) “These data are another important piece of the Kevetrin story,” said its Chief Scientific Officer, Dr. Krishna Menon. ”The continued and undiminished anti-tumor effect when a second cycle is administered is particularly significant, showing that resistance to Kevetrin is not developing.”
(Marketwire – March 29, 2010) “Research on autism has been difficult because there has been no reliable animal model,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”Fortunately, we were able to tap into some cutting edge research to find a promising model for our study.”
(Marketwire – March 22, 2010) Not attributed to DR. Menon, but, significant - Kevetrin is being developed to treat drug resistant cancers. The Company has recently reported that Kevetrin showed greater tumor shrinkage than standard therapies in animal models of resistant lung cancer, breast and colon cancer cell lines.
(Marketwire – March 15, 2010) “This is a significant event for Cellceutix,” said its Chief Scientific Officer, Dr. Krishna Menon. “The AACR is the premier cancer research organization and its annual meeting attracts scientists and pharma executives throughout the world. We are pleased to be able to present our data at the upcoming meeting.”
Not criticizing you by any means but it. Was just ten eleven twelve that emailed df for a friend in Pennsylvania that found out about wait list. Was confirmed by your cited email and a poster on a. Breast cancer board.
Tomorrow market is open and we can get back to business of share price. Thank goodness
Gov
Check asco it was ten eom gov
That guest should be careful for what they wish for...... We are on borrowed time here in FL, eight years without a direct hit, at some point that will change. While weather is fascinating, no desire to see a Cat 2 or higher up close, I would be long gone before that if I lived right on the coast and in the storm surge zone....
I did not mean to say in absolutes. I was simply trying to point out the significance of multiple cycles. Dr. Jorgensen also stressed this point at Biotech Showcase.
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There are so many factors at play that it is ridiculous at this point to speak in absolutes.
Actually there is a waiting list for the Kevetrin trial. A poster here called DF and was told about the waiting list. Dr. Menon also said he does not expect a shortage of patients. Of course not everyone qualifies. Karen’s friend is an example.
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If things were so black and white there would be many more patients lining up for Kevetrin and many more investors as well, which there aren't.
As one guest put it, I paid for a full hurricane and this is all I got?
Big Island didn't fair as well as Oahu. Sadly, the occupants of a car perished trying to reach safety crossing a storm swollen stream.
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BK I hope you faired well in the recent storms in Hawaii,
Good Luck and GOD Bless......BUT pleeeeeease...enough already...
http://www.youtube.com/watch?v=d8cpkwPAbY0
GIDDDDDDDY UP & GOOOOOOOOOOOOOOOOOOOOOOO CTIX !
I am pretty sure the K trial starting dosage was 10mg/m2, not 15mg/kg
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