Innovation Pharmaceuticals to Complete Phase 2 Trial of Brilacidin for Oral Mucositis in Cancer Patients
GlobeNewswire•October 18, 2017
Comment
BEVERLY, Mass., Oct. 18, 2017 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals Inc. (IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report that all patients participating in the Phase 2 trial of Brilacidin-OM for the prevention and treatment of Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients have completed therapy and the last patient post-treatment follow-up examination is scheduled for next week.
•Brilacidin oral rinse being developed as a preventative Oral Mucositis treatment
•OM represents a large unmet medical need and sizable market opportunity
As announced on October 2, 2017, the last patient recently completed the therapeutic regimen in the double-blind study. 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. Innovation Pharmaceuticals anticipates reporting topline results later this quarter.
“There are no FDA-approved preventative or curative treatments for OM in patients with Head and Neck Cancer. As a result, a tremendous market opportunity exists in helping hundreds of thousands of patients worldwide who suffer from this painful and debilitating condition as a consequence of receiving cancer therapy,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We look forward to finishing the final follow-up visit, then unblinding and analyzing the full dataset from the study. Moreover, we remain optimistic that one day we will help address, in a substantial way, this area of considerable unmet medical need.”
On a related note, the Company recently published a blog post on its website further discussing the OM market opportunity. An excerpt from the blog post is as follows:
“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 severe 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.). One company in the OM space projects the worldwide OM market opportunity to be as high as $2.6 billion annually.”
Interested parties can read the full post at the link below:
http://www.ipharminc.com/new-blog/2017/10/17/...-mucositis
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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About the Company
Headquartered in Beverly, Massachusetts, Innovation Pharmaceuticals Inc. (IPI) is publicly-traded under the company symbol “IPIX”. The Company is clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. The Company believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. The Company’s Psoriasis drug candidate Prurisol completed a Phase 2 trial and a Phase 2b study is ongoing. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. The Company’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and the Company has commenced a Phase 2 study in Ovarian Cancer. In the laboratory, Kevetrin has been shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Brilacidin, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative Oral Mucositis (OM) by more than 94% compared to placebo. The Company is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of OM in patients with Head and Neck Cancer; interim results have shown a marked reduction in the incidence of severe OM (WHO Grade ≥ 3). The Company’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”). Topline results are now available for the Phase 2, open label Proof-of-Concept trial, treating patients with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). The Company has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Company website at www.IPharmInc.com.
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They can try and down play this as fluff all they want. Every company out there announces trial completion. Could they have waited till next week after the last patient was examined? Probably. Who cares. I don't think it as fluff. Certainly a heads up that if you're not in, time is running out.
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