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Innovation Pharmaceuticals Reports Positive Topline Results from Phase 2 Placebo-Controlled Trial of Brilacidin for the Prevention of Oral Mucositis in Head and Neck Cancer Patients; Company Targets a Therapeutic Leadership Position in Global OM Market
Innovation Pharmaceuticals Reports Positive Topline Results from Phase 2 Placebo-Controlled Trial of Brilacidin for the Prevention of Oral Mucositis in Head and Neck Cancer Patients; Company Targets a Therapeutic Leadership Position in Global OM Market.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\n\n BEVERLY, Mass., Dec. 11, 2017 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today presented successful topline results from the Company's randomized, double-blind, placebo-controlled, Phase 2 clinical trial of Brilacidin (see NCT02324335) for the prevention and control of Oral Mucositis (OM) in patients receiving chemoradiation for treatment of Head and Neck Cancer. Brilacidin-OM is being developed under an FDA Fast Track designation for this indication.\n Summary of Topline Results from the Placebo-Controlled Phase 2 Trial Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy.Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.  Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%.Trial results support continued and expedited development of Brilacidin-OM. Clinical Trial Background In this trial, Head and Neck Cancer patients self-administered Brilacidin (45 mg/15 ml oral rinse—“swish and spit”) or placebo three times daily across 7 consecutive weeks (49 days). Of the 61 patients randomized, 46 patients met the cumulative radiation dose criteria of at least 55 Gy—the minimum treatment threshold for inclusion in the efficacy population—and 39 of these patients met more strict criteria for inclusion in the “per protocol” study population. The trial’s primary endpoint was established as reduced incidence of severe OM (defined as Grade ≥ 3 on the WHO Oral Mucositis scale) experienced by patients during radiation therapy. Topline results reveal a clear reduction in the incidence of severe OM (WHO Grade ≥ 3) in patients treated with Brilacidin-OM as compared to those on placebo. Brilacidin also appeared generally safe and well-tolerated across all treated patients (the safety population). Primary Efficacy Results: Incidence of severe OM (WHO Grade ≥ 3)  Active (Brilacidin)Control (Placebo)Modified Intent to Treat (mITT) Population (n=46)9 of 21 patients (42.9 %)15 of 25 patients (60.0%)Per Protocol (PP) Population (n=39)   7 of 19 patients (36.8%)12 of 20 patients (60.0%) Overall reduction in observed severe Or...