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
BEVERLY, Mass., October 26, 2017 (GLOBE NEWSWIRE) – Innovation Pharmaceuticals Inc. (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the completion of the Phase 2 trial (see link NCT02324335) of Brilacidin-OM for the prevention and treatment of Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy (CRT). The final patient in the Phase 2 randomized, placebo-controlled clinical trial completed their post-therapy follow-up examination this week. 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.
The primary objectives of the trial are the evaluation of the efficacy of Brilacidin-OM in reducing the incidence of severe OM (WHO Grade ≥3) compared to placebo during seven weeks of study treatment/CRT, and assessment of the safety and tolerability of this novel OM oral rinse therapy. A secondary objective includes evaluating the efficacy of Brilacidin in reducing the duration of severe OM.
The completion of the trial represents an important milestone, positioning the Company to address a significant unmet medical need. There are currently no FDA-approved drugs for preventing OM in patients with Head and Neck Cancer receiving chemoradiation. This painful condition affects upwards of 90 percent of patients in this population as well as a large number of patients receiving CRT for other cancers.
The Company believes that a successful Phase 2 trial would be a major breakthrough. Fast Track designation by the Food and Drug Administration (FDA) for Brilacidin-OM has already been awarded. In addition, the Company plans to apply for FDA Breakthrough Therapy Designation should top-line end of study results reflect similar efficacy (and safety) to that observed at interim, in which patients treated with Brilacidin-OM experienced a markedly reduced rate of severe OM compared to those on placebo.
“By 2030, the global annual incidence of Head and Neck Cancer is expected to exceed 1 million cases,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “It’s a horribly debilitating condition that causes tremendous suffering and leads to corresponding delays in clinical care, adding to costs and complications, for those who experience it. We look forward to compiling and releasing the topline Brilacidin-OM data, toward advancing it into a potential pivotal Phase 3 clinical trial—a final step toward Brilacidin-OM possibly emerging as the world’s first-ever approved preventative treatment for Oral Mucositis in this population.”
About Brilacidin
Brilacidin is Innovation Pharmaceuticals’ lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, the Company is studying Brilacidin’s effect on Oral Mucositis (under Fast Track designation) and on Ulcerative Proctitis / Proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: Atopic Dermatitis, Hidradenitis Suppurativa and Acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.
Learn more here:
http://www.ipharminc.com/brilacidin-1
BEVERLY, Mass., October 26, 2017 (GLOBE NEWSWIRE) – Innovation Pharmaceuticals Inc. (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the completion of the Phase 2 trial (see link NCT02324335) of Brilacidin-OM for the prevention and treatment of Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy (CRT). The final patient in the Phase 2 randomized, placebo-controlled clinical trial completed their post-therapy follow-up examination this week. 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.
The primary objectives of the trial are the evaluation of the efficacy of Brilacidin-OM in reducing the incidence of severe OM (WHO Grade ≥3) compared to placebo during seven weeks of study treatment/CRT, and assessment of the safety and tolerability of this novel OM oral rinse therapy. A secondary objective includes evaluating the efficacy of Brilacidin in reducing the duration of severe OM.
The completion of the trial represents an important milestone, positioning the Company to address a significant unmet medical need. There are currently no FDA-approved drugs for preventing OM in patients with Head and Neck Cancer receiving chemoradiation. This painful condition affects upwards of 90 percent of patients in this population as well as a large number of patients receiving CRT for other cancers.
The Company believes that a successful Phase 2 trial would be a major breakthrough. Fast Track designation by the Food and Drug Administration (FDA) for Brilacidin-OM has already been awarded. In addition, the Company plans to apply for FDA Breakthrough Therapy Designation should top-line end of study results reflect similar efficacy (and safety) to that observed at interim, in which patients treated with Brilacidin-OM experienced a markedly reduced rate of severe OM compared to those on placebo.
“By 2030, the global annual incidence of Head and Neck Cancer is expected to exceed 1 million cases,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “It’s a horribly debilitating condition that causes tremendous suffering and leads to corresponding delays in clinical care, adding to costs and complications, for those who experience it. We look forward to compiling and releasing the topline Brilacidin-OM data, toward advancing it into a potential pivotal Phase 3 clinical trial—a final step toward Brilacidin-OM possibly emerging as the world’s first-ever approved preventative treatment for Oral Mucositis in this population.”
About Brilacidin
Brilacidin is Innovation Pharmaceuticals’ lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, the Company is studying Brilacidin’s effect on Oral Mucositis (under Fast Track designation) and on Ulcerative Proctitis / Proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: Atopic Dermatitis, Hidradenitis Suppurativa and Acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.
Learn more here:
http://www.ipharminc.com/brilacidin-1
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