BEVERLY, Mass., October 2, 2017 (GLOBE NEWSWIRE) – Innovation Pharmaceuticals Inc., (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces that the last patient has completed study treatment in the Company’s Phase 2 clinical trial of Brilacidin for the prevention and treatment of severe Oral Mucositis (OM) in patients undergoing chemoradiation for Head and Neck Cancer. A total of 61 patients were enrolled in the double-blinded study.
One of the primary objectives of the study (see NCT02324335) is to evaluate the efficacy of Brilacidin in reducing the incidence of severe Oral Mucositis (WHO Grade ≥3) compared to placebo after seven weeks of study treatment. Another primary objective is to assess the safety and tolerability of Brilacidin.
Secondary objectives include evaluating the efficacy of Brilacidin in reducing the duration of severe OM (WHO Grade ≥3) and delaying the onset of severe OM (WHO Grade ≥3).
Interim results released earlier this year (see the March 27, 2017 press release) showed a markedly reduced rate of severe OM (WHO Grade ≥ 3) in patients treated with Brilacidin while undergoing chemoradiation and who received at least 55 Gy cumulative units of radiation.
“The final patient completing study treatment in this Phase 2 clinical trial is yet another achievement in the development of Brilacidin,” commented Arthur P. Bertolino, MD PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Oral mucositis represents a significant treatment challenge to hundreds of thousands of patients and their team of doctors every year. Moreover, costs associated with managing OM place a substantial financial burden on our healthcare system due to a lack of safe and efficacious therapies to not only treat the condition, but prevent it. Over the coming weeks, patients will complete their per-protocol follow up visits after which time the study data will be unblinded. We believe a successful trial for this indication would be a medical breakthrough and likely generate significant interest as the market for a drug that can help prevent severe OM is estimated to be substantial."
Oral Mucositis is a frequent, painful and debilitating complication of chemoradiation commonly manifesting in the treatment of Head and Neck Cancer. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak or eat (requiring the insertion of a feeding tube) and are more susceptible to bacterial infections, with severe cases leading to hospitalization and increased treatment costs of up to $25,000. There currently are no approved medications for the prevention of OM in this population, with only limited palliative care options available. Worldwide, the potential market for OM is expected to exceed $1 billion in the next few years.