Business
Innovation Pharmaceuticals and FDA Agree to Waive Initial Pediatric Study Plan Requirement Regarding Brilacidin for the Prevention of Oral Mucositis
Innovation Pharmaceuticals and FDA Agree to Waive Initial Pediatric Study Plan Requirement Regarding Brilacidin for the Prevention of Oral Mucositis.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\n BEVERLY, Mass., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders the Company received notification from the Food and Drug Administration (FDA) that a waiver has been granted eliminating the need to study Brilacidin, for the prevention of Severe Oral Mucositis in Head and Neck Cancer (HNC) patients receiving chemoradiation, in pediatric populations. The granting of this waiver now enables the Company to develop Brilacidin in a more focused manner in adult patient populations where Oral Mucositis has the greatest impact. In other news, the Company will provide shortly an update on continuing clinical development of Brilacidin for Inflammatory Bowel Disease, including the status of planned clinical work in Ulcerative Proctitis/Ulcerative Proctosigmoiditis. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: http://www.ipharminc.com/email-alerts/ 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 (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019. 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 Infection. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred...