BEVERLY, MA – October 24, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted an End-of-Phase 2 meeting with Innovation Pharmaceuticals for its clinical development program of Brilacidin oral rinse for the prevention of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving an aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is the standard of care. In this patient population, the incidence of Severe OM was reduced to 25.0% in the modified Intent-to-Treat (mITT) population, versus 71.4% of patients on placebo. In the Per Protocol (PP) patient group, incidence of Severe OM dropped to 14.3% for patients receiving Brilacidin-OM, compared to 72.7% among those receiving placebo.
The completed Phase 2 study met its primary endpoint, showing a reduction of Severe OM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of Severe OM and in delaying the onset of Severe OM.
Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is positioned compared to other investigational Oral Mucositis drugs currently in clinical development.
About Brilacidin and Severe Oral Mucositis
There currently are no FDA-approved drugs for the prevention of SOM (WHO Grade ≥ 3) in HNC patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and worldwide, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop SOM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent.