B-OM Due Diligence Lastest Update 10/27/2016
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Posted On: 11/03/2017 4:43:46 PM
B-OM Due Diligence
Lastest Update
10/27/2016 - 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
"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."
11/25/2015 - FDA Grants Fast Track Designation to Cellceutix’s Brilacidin-OM for Oral Mucositis
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 Competitor
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/
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
OM Presentation
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
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
10/27/2016 - 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
"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."
11/25/2015 - FDA Grants Fast Track Designation to Cellceutix’s Brilacidin-OM for Oral Mucositis
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 Competitor
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/
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
OM Presentation
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
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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