Innovation Pharma seeks guidance from EMA for Brilacidin oral rinse in a Phase III program of severe Oral Mucositis
Innovation Pharmaceuticals, informs 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 III 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 III scientific guidance from the EMA regarding the Brilacidin OM program. In December, Innovation Pharmaceuticals completed an End-of-Phase II Meeting with the FDA, during which an acceptable Phase III development pathway was agreed upon to advance Brilacidin.