BEVERLY, Mass., April 23, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders of a recent publication in the Journal of the American Medical Association (JAMA), a leading independent, international journal for medical professionals, detailing data from a clinical study1 on the effect of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash vs placebo on radiotherapy-related oral mucositis pain. A corresponding editorial2, titled, “The Search for an Effective Therapy and Pain Relief for Oral Mucositis,” accompanied the article. Both the published JAMA article and editorial are highly relevant for development of Brilacidin oral rinse under a U.S. Food and Drug Administration (FDA) Fast Track designation as a new drug candidate to decrease the incidence of severe Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
The clinical study recruited 275 patients randomized 1:1:1 to receive: doxepin; diphenhydramine-lidocaine-antacid; or placebo mouthwash. Both active mouthwashes assessed in the study proved to be of minimal help during the first 4 hours after administration in treating radiation-induced mucositis. While statistically improvements were observed in relation to pain scores, they were not deemed clinically important (minimal clinically important difference was a 3.5-point change). Compared with placebo, diphenhydramine-lidocaine-antacid led to a 3.0-point improvement (95% CI 0.1-5.9, P=0.004) while the doxepin mouthwash led to a 2.9-point improvement (95% CI 0.2-6.0, P=0.02). Doxepin but not diphenhydramine-lidocaine-antacid mouthwash was also associated with drowsiness, unpleasant taste, and higher frequency of stinging or burning than placebo.
The accompanying editorial emphasized the study’s limitations: “The distinction between statistical significance and clinical importance is relevant in this study, and the findings suggest that pain relief was short-term and limited among many of the patients.” Closing with the observation: “[T]he search for an effective, safe therapy for oral mucositis and its associated pain needs to continue.”
“As the JAMA mouthwash study results show, it’s an ongoing tragedy that cancer patients must currently rely on, at best, minimally effective short-term symptom relief when trying to manage their oral mucositis,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Our clinical testing of Brilacidin oral rinse in Head and Neck Cancer patients undergoing chemoradiation, to date, has shown that it markedly decreases the incidence of severe oral mucositis. This is in stark contrast to the limited benefit provided by the mouthwashes in the quoted article, a current common treatment approach, as well as the similarly minimally beneficial, largely palliative, coating agents in clinical use. A potentially transformative treatment, Brilacidin, after years of largely ineffective treatment attempts by others, may be on the cusp of helping to solve this global unmet need in cancer care.”
The Company continues to build upon its recent productive End-of-Phase 2 meeting with the FDA through ongoing interaction with the European Medicines Agency (EMA). The first stage of review by the EMA regarding the Company’s application for Scientific Advice was recently completed. The Company looks forward to advancing its planned Phase 3 clinical development for the Brilacidin oral rinse program, in both the United States and Europe.
About Brilacidin Phase 2 Results in Treating Severe Oral Mucositis
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 SOM 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 SOM dropped to 14.3% for patients receiving Brilacidin oral rinse, compared to 72.7% among those receiving placebo.
The completed Phase 2 study met its primary endpoint, showing a reduction of SOM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of SOM and in delaying the onset of SOM.
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.
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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. 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 Infections. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations, and has successfully completed a Phase 2 trial in ovarian cancer. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, including planned Phase 3 trials of Brilacidin, receipt of the official meeting minutes from the FDA and the contents thereof, our future drug development plans, other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACT
Innovation Pharmaceuticals Inc.