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Innovation Pharmaceuticals Receives FDA End-of-Phase 2 Meeting Minutes
Innovation Pharmaceuticals Receives FDA End-of-Phase 2 Meeting Minutes.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\nBEVERLY, Mass., May 01, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, announced today it has received Food and Drug Administration (FDA) End-of-Phase 2 (EoP2) meeting minutes, helping to guide the Company’s planned Phase 3 program for Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving chemoradiation. Brilacidin oral rinse is being developed under FDA Fast Track designation for Oral Mucositis (OM).\n During the EoP2 meeting convened in December 2018, the Company and FDA agreed to an acceptable Brilacidin Phase 3 development pathway. The guidance from the FDA now also helps to frame ongoing discussions with the European Medicines Agency (EMA) as part of the Scientific Advice process. The purpose of both of these interactions is to ensure that proposed plans meet regulatory requirements for New Drug Application (NDA)/Marketing Authorization Application (MAA) filings and, ultimately, to obtain approval of Brilacidin for SOM in HNC in both the United States and Europe. “Productive regulatory meetings for our Brilacidin SOM program with U.S. and European agencies are significant Company milestones,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Brilacidin oral rinse, to decrease the incidence of SOM, represents a potential future regimen for millions of head and neck cancer patients where no approved drug is available today. Furthermore, our hope is that Brilacidin will eventually emerge as a treatment for other indications where SOM also is a frequent side-effect of cancer therapies.” “It is time that the current standard of care for SOM takes a leap forward and a new market emerges,” added Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “I am reminded of drugs for not only rare diseases that were overlooked by the market during development and then went on to become ‘company makers,’ but also a drug such as Tagamet. Eventually, it became the first blockbuster drug ever by treating the common problem of acid reflux, a disease that was casually written off for decades as not having an effective treatment ...