B-OM Due Diligence
Lastest Update
4/16/2018 - Innovation Pharmaceuticals Data from Phase 2 Brilacidin Oral Mucositis (OM) Trial in Head and Neck Cancer Show Notable Reductions in Median Duration of Severe OM and in Number of Unplanned Visits/Hospital Admissions Due to OM
· Median Duration of Severe Oral Mucositis (SOM) Reduced to Less Than One Day
· No Unplanned Office Visits, Emergency Department Visits, and/or Hospital Admissions Due to OM in Brilacidin-OM Arm vs. Four in Placebo Arm
· Data Align with Previously Reported 80.3% Risk Reduction in Incidence of Severe OM in Per Protocol Population Receiving Aggressive Chemotherapy Regimen Compared to Placebo
http://www.ipharminc.com/press-release/2018/4...nned-visit
4/9/2018 - Innovation Pharmaceuticals Phase 2 Oral Mucositis Trial Additional Data Show Brilacidin-OM Demonstrated A Significant Reduction in the Incidence of Severe Oral Mucositis in Patients with Head and Neck Cancer (HNC) Receiving Aggressive Chemotherapy Regimen
“For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the aggressive chemotherapy regimen reduced the incidence of SOM by 65.0% ([incidence control- incidence active]/incidence control) as compared with placebo (Brilacidin: 25.0%; placebo: 71.4%; p=0.0480). For the Per Protocol (PP) population, Brilacidin-OM in the aggressive chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249).”
http://www.ipharminc.com/press-release/2018/4...-mucositis
3/15/2018 - Innovation Pharmaceuticals Views Brilacidin-OM as Clearly Differentiated Compared to Limited Competition for Preventing Severe Oral Mucositis
“The Company is currently focused on completing the Clinical Study Report for its Phase 2 clinical trial (see NCT02324335) evaluating Brilacidin’s ability to safely prevent and attenuate SOM in HNC patients receiving chemoradiation and compiling a Briefing Package for discussion with the FDA.”
http://www.ipharminc.com/press-release/2018/3...-mucositis
1/29/2018 - Innovation Pharmaceuticals Brilacidin Franchise Anchored in Three Clinical Indications — Oral Mucositis, Inflammatory Bowel Disease and Serious Skin Infections; Expands into Dermatologic Diseases
"A leading international drug manufacturer has been engaged with to bulk produce commercial-quality Brilacidin, aimed at lowering patient drug cost and anticipating future drug needs in preparation for expedient market introduction. This critical step also proactively facilitates future patient and insurance reimbursement adoption through favorable cost savings;"
http://www.ipharminc.com/press-release/2018/1...c-diseases
1/3/2018 - Innovation Pharmaceuticals Brilacidin Meets Key Secondary Endpoint in Phase 2 Trial, Delays Onset of Severe Oral Mucositis (SOM)
"Onset of Severe Oral Mucositis: Based on Kaplan-Meier curves, Brilacidin-OM oral rinse showed a clear separation from placebo in delaying the onset of SOM—particularly the period from approximately 28-42 days, after the initiation of treatment, during which the incidence of SOM rose strikingly in the placebo group while not in the group being treated with Brilacidin."
http://www.ipharminc.com/press-release/2018/1...ositis-som
Kaplan-Meier Curves
12/18/2017 - Innovation Pharmaceuticals Brilacidin Oral Mucositis Program Moving Forward Based Upon Positive Anchoring Phase 2 Results and Increased Brilacidin Franchise Value
"Towards commercial planning, the Company has begun exploring potential unit dose drug product packaging in the form of a sachet. Sachets, which people are very familiar with and use on an almost daily basis (e.g., sugar packets, artificial sweeteners) increasingly are being developed as a novel means of patient-friendly, drug delivery. Manufacturing plans for drug substance appropriate for late phase testing and eventual market introduction are also underway."
http://www.ipharminc.com/press-release/2017/1...hise-value
12/12/2017 - Innovation Pharmaceuticals Granted European Patent for Brilacidin in the Prevention of Oral Mucositis
"The European patent supplements other Brilacidin-OM patents that have been granted in the United States, Asia (Japan, Taiwan, China), Oceania (Australia) and South Africa. All currently issued patents have an expiration date of 2032. Additional Brilacidin-OM patent applications are pending in other key markets including Russia and South Korea."
http://www.ipharminc.com/press-release/2017/1...-mucositis
12/11/2017 - Innovation Pharmaceuticals Reports Positive Topline Results from Phase 2 Placebo-Controlled Trial of Brilacidin for the Prevention of Oral Mucositis in Head and Neck Cancer Patients
Summary of Topline Results from the Placebo-Controlled Phase 2 Trial
· Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy.
· Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.
· Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%.
· Trial results support continued and expedited development of Brilacidin-OM.
http://www.ipharminc.com/press-release/2017/1...r-patients
11/16/2017 - Innovation Pharmaceuticals Offers Perspectives on Brilacidin as a Potential Preventative Treatment for Oral Mucositis in Head and Neck Cancer Patients
"Formal collaboration with pharmaceutical companies that have expressed an interest in partnering Brilacidin-OM may well assist further with expediting the drug candidate’s development timetable. Some of these partnering conversations have matured to the point of potentially structuring mutually beneficial licensing agreements, pending the final Phase 2 study results."
http://www.ipharminc.com/press-release/2017/1...r-patients
10/26/2017 - Innovation Pharmaceuticals Aims to Develop First Drug for Approval in Prevention of Oral Mucositis in Head and Neck Cancer Patients as Phase 2 Clinical Trial of Brilacidin Completes
"The Company has begun the process of closing trial study sites and is now aggregating patient data for top-line analysis, to be reported this quarter."
http://www.ipharminc.com/press-release/2017/1...wbej1vz0x1
10/18/2017 - Innovation Pharmaceuticals to Complete Phase 2 Trial of Brilacidin for Oral Mucositis in Cancer Patients
"After the final patient post-treatment follow-up is conducted next week, the Company will focus on the process of concluding the study, including closing clinical sites and aggregating and analyzing data."
http://www.ipharminc.com/press-release/2017/1...r-patients
10/2/2017 - Final Patient Completes Treatment in Innovation Pharmaceuticals Phase 2 Trial of Brilacidin for Preventing Oral Mucositis in Cancer Patients
"... today announces that the last patient has completed study treatment in the Company’s Phase 2 clinical trial of Brilacidin for the prevention and treatment of severe Oral Mucositis (OM) in patients undergoing chemoradiation for Head and Neck Cancer."
http://www.ipharminc.com/press-release/2017/1...-mucositis
8/7/2017 - Innovation Pharmaceuticals Completes Patient Enrollment in Phase 2 Study of Brilacidin for the Prevention of Severe Oral Mucositis
"... today announces that it has completed patient enrollment for its ongoing Phase 2 clinical study of Brilacidin for the prevention of Severe Oral Mucositis (OM). A total of 61 patients have been enrolled, with topline results anticipated in 4Q2017."
http://www.ipharminc.com/press-release/2017/8...-mucositis
3/27/2017 - Cellceutix Reports Very Encouraging Interim Analysis of Phase 2 Drug Candidate Brilacidin for Severe Oral Mucositis (OM) in Head and Neck Cancer Patients; High Potential for Preventative Treatment
"Study showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent)"
Primary Efficacy Results: Incidence of Severe OM (WHO Grade ≥ 3)
• Active Arm (Brilacidin): 2 of 9 patients (22.2 percent)
• Control Arm (Placebo): 7 of 10 patients (70 percent)
Secondary Efficacy Results: Duration of Severe OM (WHO Grade ≥ 3)
• Active Arm (Brilacidin): Mean 10.5 days (Range 3 to 18 days; 2 patients)
• Control Arm (Placebo): Mean 14 days (Range 3 to 39 days; 7 patients)
http://www.ipharminc.com/press-release/2017/3...-treatment
Fast Track
11/25/2015 - FDA Grants Fast Track Designation to Cellceutix’s Brilacidin-OM for Oral Mucositis
"The FDA established the Fast Track Designation process to facilitate the development, and expedite the review of, drugs that have the potential to treat serious and life threatening conditions and fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to the FDA and could qualify for other programs to expedite development, including priority review and accelerated approval."
http://www.ipharminc.com/press-release/2016/1...-mucositis
Study Design
CTIX-BRI-205 is a Phase 2 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Brilacidin as an oral rinse in preventing and controlling OM in patients receiving chemoradiation therapy for Head and Neck Cancer. The study is anticipated to enroll approximately 60 patients in the United States, 30 each to Brilacidin treatment or to placebo (water). Brilacidin (45 mg/15 ml oral rinse—“swish and spit”) is administered 3 times daily across 7 weeks (49 days). Pharmacokinetics of Brilacidin are to be evaluated if there is measurable systemic exposure (from drug concentrations in plasma).
The Brilacidin OM trial uses a World Health Organization (WHO) OM Grading Scale, a common measurement tool in assessing the presence and severity of OM, as defined below.
WHO Scale for OM
• Grade 0 = None
• Grade 1 = Erythema and Mouth Pain Soreness; no Ulceration/Pseudomembrane formation
• Grade 2 = Ulceration/Pseudomembrane formation; solid diet
• Grade 3 = Ulceration/Pseudomembrane formation; liquid diet
• Grade 4 = Ulceration/Pseudomembrane formation; not able to tolerate a solid or liquid diet (except enough liquid for medication)
About Oral Mucositis
Oral Mucositis (OM) is a frequent, painful and debilitating complication of chemoradiation commonly manifesting in the treatment of Head and Neck Cancer. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak or eat (requiring the insertion of a feeding tube) and are more susceptible to bacterial infections, with severe cases leading to hospitalization and increased treatment costs of up to $25,000. Affecting over 500,000 people in the United States, there currently are no approved medications for the prevention of OM in this population, with only limited palliative care options available. Worldwide, the potential market for OM is expected to exceed $1 billion in the next few years.
For more information on the CTIX-BRI-205 Phase 2 study, please visit:
https://clinicaltrials.gov/ct2/show/NCT02324335
OM Market
"Head and Neck Cancer (HNC) patients -- comprising an estimated 65,000 newly diagnosed cases in the U.S. alone in 2017, and an estimated 700,000 worldwide (source: GLOBOCAN) -- are at greatest risk of developing OM (a 90 to 100 percent rate of occurrence). By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM during the course of their chemo/radiotherapy.
Estimates vary as to the market size (in dollars) of an effective OM treatment, for HNC-only patients, across major markets (U.S., Europe and Japan), ranging between $500 million and $1.5 billion on an annual basis (sources: GlobalData; Redington Inc., pdf). One company in the OM space projects the worldwide OM market opportunity to be as high as $2.6 billion annually."
http://www.ipharminc.com/new-blog/2017/10/17/...-mucositis
Potential Competitors
A Billion Dollar Market Just Waiting for a New Oral Mucositis Drug: Five Companies That Want It
http://www.baystreet.ca/stockstowatch/2658/A-...at-Want-It
Some of the players operating for the oral mucositis are
- Izun Pharmaceutical Ltd (US)
- Shoreline Pharmaceuticals Inc. (USA)
- Himalaya (India)
- AMAG Pharmaceuticals Inc. (USA)
- Kinnear Pharmaceuticals (US)
- Celleutix Corporation(USA)
- Soligenix Inc. (US)
- Oragenics (US)
https://investorshub.advfn.com/boards/read_ms...=135072984
Amgen Kepivance (IV)
"In addition to a lower incidence of severe oral mucositis, patients receiving palifermin had almost one week less severe mucositis compared to those receiving placebo (10.4 days vs 3.7 days). Furthermore, palifermin-treated patients reported 60 percent less soreness of the mouth and throat, required lower doses of painkillers and less total parenteral nutrition use (11 percent versus 40 percent with placebo)."
http://www.amgen.com/media/news-releases/2003...-patients/
"The cost for Kepivance intravenous powder for injection 6.25 mg is around $14,401 for a supply of 6 powder for injection, depending on the pharmacy you visit."
https://www.drugs.com/price-guide/kepivance
Soligenix SGX942 (IV)
"n the 1.5 mg/kg treatment group, the median duration of severe oral mucositis was decreased by 50%, from 18 days to 9 days (p=0.099), meeting the prospectively defined statistical threshold of p<0.1 in the study protocol. Further, patients receiving the most aggressive CRT in this dose group had even more striking reductions in their median duration of severe oral mucositis of 67%, from 30 days to 10 days (p=0.040)."
http://www.soligenix.com/news/soligenix-annou...-patients/
Validive (applies to gum)
"The incidence of SOM (primary endpoint) was reduced by 26.3% (40% relative to placebo) in OPC patients treated with Validive (100 μg) (p=0.09)"
http://monopartherapeutics.com/phase_II
"Onxeo Grants Exclusive Worldwide License of Validive® developed for the treatment of oral severe mucositis to Monopar Therapeutics"
https://www.onxeo.com/onxeo-grants-exclusive-...rapeutics/
Izun IZN-6N4 (oral rinse)
"Not only did patients treated with IZN-6N4 have less mouth and throat pain and soreness than controls, but importantly, they were also more able to maintain their weights throughout the course of radiotherapy. The data supports that the best efficacy of IZN-6N4 was related to its initiation of use at the start of chemoradiation."
http://www.businesswire.com/news/home/2017101...ts-Phase-2
Oragenics AG013 (oral rinse)
"Data from the Phase 1B trial published in the journal Cancer showed AG013 was safe, well tolerated, and demonstrated preliminary efficacy with a 35% reduction in the duration of ulcerative OM compared to placebo."
https://www.oragenics.com/news-media/press-re...nfirmatory
OM Presentation
January 2018 Corporate Overview
https://static1.squarespace.com/static/571535...erview.pdf
2017 Drug Discovery and Therapy World Congress
https://static1.squarespace.com/static/571535...ul2017.pdf
25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2015)
https://static1.squarespace.com/static/571535...poster.pdf
OM Blog
12/11/2017 - Brilacidin-OM Called a “Top Contender” in Oral Mucositis Market
http://www.ipharminc.com/new-blog/2017/12/11/...tis-market
10/17/2017 - The Market Opportunity in Oral Mucositis
http://www.ipharminc.com/new-blog/2017/10/17/...-mucositis
8/7/2017 - Brilacidin for the Prevention of Severe Oral Mucositis
http://www.ipharminc.com/new-blog/2017/8/7/br...-mucositis
5/19/2017 - On the Unmet Medical Need in Oral Mucositis: Brilacidin as a Potential First-in-Class Preventative Treatment
http://www.ipharminc.com/new-blog/2017/5/17/o...-treatment
Stephen Sonis, MD
Scientific Advisor, Oral Mucositis
Dr. Sonis is one of the world’s foremost experts in the research and clinical treatment of cancer-related oral mucosal toxicities. He currently holds appointments at the Harvard School of Dental Medicine as Professor of Oral Medicine (part-time), and is a Senior Surgeon at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital. Dr. Sonis also is a Founder and Chief Scientific Officer of Biomodels, LLC, a preclinical contract research organization. Widely respected by his professional peers, he is the author of over 250 original publications, reviews and chapters, 11 books, and 5 patents, serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology. Dr. Sonis is a graduate of Tufts University and Harvard University and completed his post-doctoral education at Oxford University.
http://www.ipharminc.com/senior-management-1/
Cellceutix Corporation Welcomes Dr. Stephen T. Sonis to its Scientific Advisory Board
http://www.ipharminc.com/press-release-2/2016...sory-board
Stephen T. Sonis, DMD, DMSc, on Radiotherapy-Induced Oral Complications
https://vimeo.com/182309692
Lastest Update
4/16/2018 - Innovation Pharmaceuticals Data from Phase 2 Brilacidin Oral Mucositis (OM) Trial in Head and Neck Cancer Show Notable Reductions in Median Duration of Severe OM and in Number of Unplanned Visits/Hospital Admissions Due to OM
· Median Duration of Severe Oral Mucositis (SOM) Reduced to Less Than One Day
· No Unplanned Office Visits, Emergency Department Visits, and/or Hospital Admissions Due to OM in Brilacidin-OM Arm vs. Four in Placebo Arm
· Data Align with Previously Reported 80.3% Risk Reduction in Incidence of Severe OM in Per Protocol Population Receiving Aggressive Chemotherapy Regimen Compared to Placebo
http://www.ipharminc.com/press-release/2018/4...nned-visit
4/9/2018 - Innovation Pharmaceuticals Phase 2 Oral Mucositis Trial Additional Data Show Brilacidin-OM Demonstrated A Significant Reduction in the Incidence of Severe Oral Mucositis in Patients with Head and Neck Cancer (HNC) Receiving Aggressive Chemotherapy Regimen
“For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the aggressive chemotherapy regimen reduced the incidence of SOM by 65.0% ([incidence control- incidence active]/incidence control) as compared with placebo (Brilacidin: 25.0%; placebo: 71.4%; p=0.0480). For the Per Protocol (PP) population, Brilacidin-OM in the aggressive chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249).”
http://www.ipharminc.com/press-release/2018/4...-mucositis
3/15/2018 - Innovation Pharmaceuticals Views Brilacidin-OM as Clearly Differentiated Compared to Limited Competition for Preventing Severe Oral Mucositis
“The Company is currently focused on completing the Clinical Study Report for its Phase 2 clinical trial (see NCT02324335) evaluating Brilacidin’s ability to safely prevent and attenuate SOM in HNC patients receiving chemoradiation and compiling a Briefing Package for discussion with the FDA.”
http://www.ipharminc.com/press-release/2018/3...-mucositis
1/29/2018 - Innovation Pharmaceuticals Brilacidin Franchise Anchored in Three Clinical Indications — Oral Mucositis, Inflammatory Bowel Disease and Serious Skin Infections; Expands into Dermatologic Diseases
"A leading international drug manufacturer has been engaged with to bulk produce commercial-quality Brilacidin, aimed at lowering patient drug cost and anticipating future drug needs in preparation for expedient market introduction. This critical step also proactively facilitates future patient and insurance reimbursement adoption through favorable cost savings;"
http://www.ipharminc.com/press-release/2018/1...c-diseases
1/3/2018 - Innovation Pharmaceuticals Brilacidin Meets Key Secondary Endpoint in Phase 2 Trial, Delays Onset of Severe Oral Mucositis (SOM)
"Onset of Severe Oral Mucositis: Based on Kaplan-Meier curves, Brilacidin-OM oral rinse showed a clear separation from placebo in delaying the onset of SOM—particularly the period from approximately 28-42 days, after the initiation of treatment, during which the incidence of SOM rose strikingly in the placebo group while not in the group being treated with Brilacidin."
http://www.ipharminc.com/press-release/2018/1...ositis-som
Kaplan-Meier Curves
12/18/2017 - Innovation Pharmaceuticals Brilacidin Oral Mucositis Program Moving Forward Based Upon Positive Anchoring Phase 2 Results and Increased Brilacidin Franchise Value
"Towards commercial planning, the Company has begun exploring potential unit dose drug product packaging in the form of a sachet. Sachets, which people are very familiar with and use on an almost daily basis (e.g., sugar packets, artificial sweeteners) increasingly are being developed as a novel means of patient-friendly, drug delivery. Manufacturing plans for drug substance appropriate for late phase testing and eventual market introduction are also underway."
http://www.ipharminc.com/press-release/2017/1...hise-value
12/12/2017 - Innovation Pharmaceuticals Granted European Patent for Brilacidin in the Prevention of Oral Mucositis
"The European patent supplements other Brilacidin-OM patents that have been granted in the United States, Asia (Japan, Taiwan, China), Oceania (Australia) and South Africa. All currently issued patents have an expiration date of 2032. Additional Brilacidin-OM patent applications are pending in other key markets including Russia and South Korea."
http://www.ipharminc.com/press-release/2017/1...-mucositis
12/11/2017 - Innovation Pharmaceuticals Reports Positive Topline Results from Phase 2 Placebo-Controlled Trial of Brilacidin for the Prevention of Oral Mucositis in Head and Neck Cancer Patients
Summary of Topline Results from the Placebo-Controlled Phase 2 Trial
· Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy.
· Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.
· Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%.
· Trial results support continued and expedited development of Brilacidin-OM.
http://www.ipharminc.com/press-release/2017/1...r-patients
11/16/2017 - Innovation Pharmaceuticals Offers Perspectives on Brilacidin as a Potential Preventative Treatment for Oral Mucositis in Head and Neck Cancer Patients
"Formal collaboration with pharmaceutical companies that have expressed an interest in partnering Brilacidin-OM may well assist further with expediting the drug candidate’s development timetable. Some of these partnering conversations have matured to the point of potentially structuring mutually beneficial licensing agreements, pending the final Phase 2 study results."
http://www.ipharminc.com/press-release/2017/1...r-patients
10/26/2017 - Innovation Pharmaceuticals Aims to Develop First Drug for Approval in Prevention of Oral Mucositis in Head and Neck Cancer Patients as Phase 2 Clinical Trial of Brilacidin Completes
"The Company has begun the process of closing trial study sites and is now aggregating patient data for top-line analysis, to be reported this quarter."
http://www.ipharminc.com/press-release/2017/1...wbej1vz0x1
10/18/2017 - Innovation Pharmaceuticals to Complete Phase 2 Trial of Brilacidin for Oral Mucositis in Cancer Patients
"After the final patient post-treatment follow-up is conducted next week, the Company will focus on the process of concluding the study, including closing clinical sites and aggregating and analyzing data."
http://www.ipharminc.com/press-release/2017/1...r-patients
10/2/2017 - Final Patient Completes Treatment in Innovation Pharmaceuticals Phase 2 Trial of Brilacidin for Preventing Oral Mucositis in Cancer Patients
"... today announces that the last patient has completed study treatment in the Company’s Phase 2 clinical trial of Brilacidin for the prevention and treatment of severe Oral Mucositis (OM) in patients undergoing chemoradiation for Head and Neck Cancer."
http://www.ipharminc.com/press-release/2017/1...-mucositis
8/7/2017 - Innovation Pharmaceuticals Completes Patient Enrollment in Phase 2 Study of Brilacidin for the Prevention of Severe Oral Mucositis
"... today announces that it has completed patient enrollment for its ongoing Phase 2 clinical study of Brilacidin for the prevention of Severe Oral Mucositis (OM). A total of 61 patients have been enrolled, with topline results anticipated in 4Q2017."
http://www.ipharminc.com/press-release/2017/8...-mucositis
3/27/2017 - Cellceutix Reports Very Encouraging Interim Analysis of Phase 2 Drug Candidate Brilacidin for Severe Oral Mucositis (OM) in Head and Neck Cancer Patients; High Potential for Preventative Treatment
"Study showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent)"
Primary Efficacy Results: Incidence of Severe OM (WHO Grade ≥ 3)
• Active Arm (Brilacidin): 2 of 9 patients (22.2 percent)
• Control Arm (Placebo): 7 of 10 patients (70 percent)
Secondary Efficacy Results: Duration of Severe OM (WHO Grade ≥ 3)
• Active Arm (Brilacidin): Mean 10.5 days (Range 3 to 18 days; 2 patients)
• Control Arm (Placebo): Mean 14 days (Range 3 to 39 days; 7 patients)
http://www.ipharminc.com/press-release/2017/3...-treatment
Fast Track
11/25/2015 - FDA Grants Fast Track Designation to Cellceutix’s Brilacidin-OM for Oral Mucositis
"The FDA established the Fast Track Designation process to facilitate the development, and expedite the review of, drugs that have the potential to treat serious and life threatening conditions and fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to the FDA and could qualify for other programs to expedite development, including priority review and accelerated approval."
http://www.ipharminc.com/press-release/2016/1...-mucositis
Study Design
CTIX-BRI-205 is a Phase 2 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Brilacidin as an oral rinse in preventing and controlling OM in patients receiving chemoradiation therapy for Head and Neck Cancer. The study is anticipated to enroll approximately 60 patients in the United States, 30 each to Brilacidin treatment or to placebo (water). Brilacidin (45 mg/15 ml oral rinse—“swish and spit”) is administered 3 times daily across 7 weeks (49 days). Pharmacokinetics of Brilacidin are to be evaluated if there is measurable systemic exposure (from drug concentrations in plasma).
The Brilacidin OM trial uses a World Health Organization (WHO) OM Grading Scale, a common measurement tool in assessing the presence and severity of OM, as defined below.
WHO Scale for OM
• Grade 0 = None
• Grade 1 = Erythema and Mouth Pain Soreness; no Ulceration/Pseudomembrane formation
• Grade 2 = Ulceration/Pseudomembrane formation; solid diet
• Grade 3 = Ulceration/Pseudomembrane formation; liquid diet
• Grade 4 = Ulceration/Pseudomembrane formation; not able to tolerate a solid or liquid diet (except enough liquid for medication)
About Oral Mucositis
Oral Mucositis (OM) is a frequent, painful and debilitating complication of chemoradiation commonly manifesting in the treatment of Head and Neck Cancer. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak or eat (requiring the insertion of a feeding tube) and are more susceptible to bacterial infections, with severe cases leading to hospitalization and increased treatment costs of up to $25,000. Affecting over 500,000 people in the United States, there currently are no approved medications for the prevention of OM in this population, with only limited palliative care options available. Worldwide, the potential market for OM is expected to exceed $1 billion in the next few years.
For more information on the CTIX-BRI-205 Phase 2 study, please visit:
https://clinicaltrials.gov/ct2/show/NCT02324335
OM Market
"Head and Neck Cancer (HNC) patients -- comprising an estimated 65,000 newly diagnosed cases in the U.S. alone in 2017, and an estimated 700,000 worldwide (source: GLOBOCAN) -- are at greatest risk of developing OM (a 90 to 100 percent rate of occurrence). By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM during the course of their chemo/radiotherapy.
Estimates vary as to the market size (in dollars) of an effective OM treatment, for HNC-only patients, across major markets (U.S., Europe and Japan), ranging between $500 million and $1.5 billion on an annual basis (sources: GlobalData; Redington Inc., pdf). One company in the OM space projects the worldwide OM market opportunity to be as high as $2.6 billion annually."
http://www.ipharminc.com/new-blog/2017/10/17/...-mucositis
Potential Competitors
A Billion Dollar Market Just Waiting for a New Oral Mucositis Drug: Five Companies That Want It
http://www.baystreet.ca/stockstowatch/2658/A-...at-Want-It
Some of the players operating for the oral mucositis are
- Izun Pharmaceutical Ltd (US)
- Shoreline Pharmaceuticals Inc. (USA)
- Himalaya (India)
- AMAG Pharmaceuticals Inc. (USA)
- Kinnear Pharmaceuticals (US)
- Celleutix Corporation(USA)
- Soligenix Inc. (US)
- Oragenics (US)
https://investorshub.advfn.com/boards/read_ms...=135072984
Amgen Kepivance (IV)
"In addition to a lower incidence of severe oral mucositis, patients receiving palifermin had almost one week less severe mucositis compared to those receiving placebo (10.4 days vs 3.7 days). Furthermore, palifermin-treated patients reported 60 percent less soreness of the mouth and throat, required lower doses of painkillers and less total parenteral nutrition use (11 percent versus 40 percent with placebo)."
http://www.amgen.com/media/news-releases/2003...-patients/
"The cost for Kepivance intravenous powder for injection 6.25 mg is around $14,401 for a supply of 6 powder for injection, depending on the pharmacy you visit."
https://www.drugs.com/price-guide/kepivance
Soligenix SGX942 (IV)
"n the 1.5 mg/kg treatment group, the median duration of severe oral mucositis was decreased by 50%, from 18 days to 9 days (p=0.099), meeting the prospectively defined statistical threshold of p<0.1 in the study protocol. Further, patients receiving the most aggressive CRT in this dose group had even more striking reductions in their median duration of severe oral mucositis of 67%, from 30 days to 10 days (p=0.040)."
http://www.soligenix.com/news/soligenix-annou...-patients/
Validive (applies to gum)
"The incidence of SOM (primary endpoint) was reduced by 26.3% (40% relative to placebo) in OPC patients treated with Validive (100 μg) (p=0.09)"
http://monopartherapeutics.com/phase_II
"Onxeo Grants Exclusive Worldwide License of Validive® developed for the treatment of oral severe mucositis to Monopar Therapeutics"
https://www.onxeo.com/onxeo-grants-exclusive-...rapeutics/
Izun IZN-6N4 (oral rinse)
"Not only did patients treated with IZN-6N4 have less mouth and throat pain and soreness than controls, but importantly, they were also more able to maintain their weights throughout the course of radiotherapy. The data supports that the best efficacy of IZN-6N4 was related to its initiation of use at the start of chemoradiation."
http://www.businesswire.com/news/home/2017101...ts-Phase-2
Oragenics AG013 (oral rinse)
"Data from the Phase 1B trial published in the journal Cancer showed AG013 was safe, well tolerated, and demonstrated preliminary efficacy with a 35% reduction in the duration of ulcerative OM compared to placebo."
https://www.oragenics.com/news-media/press-re...nfirmatory
OM Presentation
January 2018 Corporate Overview
https://static1.squarespace.com/static/571535...erview.pdf
2017 Drug Discovery and Therapy World Congress
https://static1.squarespace.com/static/571535...ul2017.pdf
25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2015)
https://static1.squarespace.com/static/571535...poster.pdf
OM Blog
12/11/2017 - Brilacidin-OM Called a “Top Contender” in Oral Mucositis Market
http://www.ipharminc.com/new-blog/2017/12/11/...tis-market
10/17/2017 - The Market Opportunity in Oral Mucositis
http://www.ipharminc.com/new-blog/2017/10/17/...-mucositis
8/7/2017 - Brilacidin for the Prevention of Severe Oral Mucositis
http://www.ipharminc.com/new-blog/2017/8/7/br...-mucositis
5/19/2017 - On the Unmet Medical Need in Oral Mucositis: Brilacidin as a Potential First-in-Class Preventative Treatment
http://www.ipharminc.com/new-blog/2017/5/17/o...-treatment
Stephen Sonis, MD
Scientific Advisor, Oral Mucositis
Dr. Sonis is one of the world’s foremost experts in the research and clinical treatment of cancer-related oral mucosal toxicities. He currently holds appointments at the Harvard School of Dental Medicine as Professor of Oral Medicine (part-time), and is a Senior Surgeon at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital. Dr. Sonis also is a Founder and Chief Scientific Officer of Biomodels, LLC, a preclinical contract research organization. Widely respected by his professional peers, he is the author of over 250 original publications, reviews and chapters, 11 books, and 5 patents, serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology. Dr. Sonis is a graduate of Tufts University and Harvard University and completed his post-doctoral education at Oxford University.
http://www.ipharminc.com/senior-management-1/
Cellceutix Corporation Welcomes Dr. Stephen T. Sonis to its Scientific Advisory Board
http://www.ipharminc.com/press-release-2/2016...sory-board
Stephen T. Sonis, DMD, DMSc, on Radiotherapy-Induced Oral Complications
https://vimeo.com/182309692
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Innovation Pharmaceuticals Inc (IPIX) Stock Research Links
