Innovation Pharmaceuticals Requesting European Medicines Agency (EMA) Input for International Phase 3 Brilacidin Oral Mucositis Program
BEVERLY, Mass., March 15, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals, (IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that necessary documentation has been completed for the European Medicines Agency (EMA) March 15, 2019 submission cycle requesting Scientific Advice to advance Brilacidin oral rinse in a Phase 3 program for the prevention of severe Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation. The documentation is being submitted to the EMA through IPIX Pharma, Ltd., the Innovation Pharmaceuticals Irish subsidiary.
As is customary, the Company is seeking Phase 3 scientific guidance from the EMA regarding the Brilacidin OM program. In December, Innovation Pharmaceuticals completed an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA), during which an acceptable Phase 3 development pathway was agreed upon to advance Brilacidin.
For the Phase 3 program, the Company anticipates international clinical trial enrollment, with participating sites located in the U.S. and in Europe. EMA advice is integral to this plan by helping to ensure that the program meets European standards.
“Our Company is now at an inflection point, emerging as a global leader in new OM therapies. The combination of scientific advice from the FDA and the EMA will leave us well positioned to move forward into Phase 3 development with the goal of Brilacidin becoming the first effective and conveniently administered drug approved by both agencies for decreasing the incidence of OM in HNC patients,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals.
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infections. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations, and has successfully completed a Phase 2 trial in ovarian cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, including planned Phase 3 trials of Brilacidin, our future drug development plans, other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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