BEVERLY, Mass., March 14, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals, (OTCQB: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.