Company to Approach European Medicines Agency for International Development Guidance
BEVERLY, Mass., Jan. 08, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders of recent articles published in “The Lancet,” a leading independent, international journal for medical professionals, detailing data from two, separate clinical studies1,2 of radiotherapy plus ERBITUX® (cetuximab) or cisplatin in treating oropharyngeal cancer, a type of Head and Neck Cancer (HNC).
The findings from the large studies are particularly great news for the Company and relevant for development of Brilacidin oral rinse under a U.S. Food and Drug Administration (FDA) Fast Track designation as a new drug candidate for the prevention and treatment of severe Oral Mucositis (OM) in HNC patients receiving chemoradiation.
Cetuximab, an Epidermal Growth Factor Receptor inhibitor, has been hypothesized as a less toxic option to cisplatin, a drug commonly used today in combination with radiotherapy in HNC treatment regimens. While effective, cisplatin is known to have certain toxicities, including frequently causing severe OM, a debilitating and painful side effect characterized by lesions in the mouth’s mucosa that can force suspension of cancer therapy, render a patient unable to eat or drink and increase risk of sepsis, among other complications. There are currently no FDA-approved drugs for the prevention and treatment of OM for patients with solid tumors.
In each study, replacing cisplatin/radiotherapy with cetuximab/radiotherapy delivered inferior results when evaluated for overall survival, progression-free survival, or tumor control and no difference in overall severe toxicity. Although each study should be considered landmark on its own, the harmonized results are most notable in showing that the combination of cisplatin and radiotherapy will remain a standard of care in treating HNC.
“These data indicate that a cisplatin/radiotherapy regimen is likely to continue to be a mainstay in treating HNC, in spite of the drug commonly causing severe OM. A glaring critical void in patient care — and, thus, comprising a tremendous market opportunity for the Company— is in developing a safe and effective treatment that can become part of the standard regimen to prevent severe OM,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We are highly confident that Brilacidin oral rinse could fill that large therapeutic gap in cancer care and give patients preventative relief from a frequently occurring and horrible consequence of chemoradiation.”
In the Company’s successfully completed Phase 2 trial, Brilacidin oral rinse significantly reduced the incidence of severe OM (WHO Grade ≥ 3) in HNC patients receiving cisplatin administered 80-100 mg/m2 every 21 days in combination with radiotherapy. In this patient population, incidence of severe OM was reduced to 25.0 percent in the modified Intent-to-Treat population, versus 71.4 percent of placebo patients. In the Per Protocol patient group, incidence of severe OM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.
The Company recently completed an End-of-Phase 2 meeting with the FDA, paving the way for pivotal trials of Brilacidin oral rinse for HNC patients receiving chemoradiation. In Phase 3 trials, Brilacidin will be evaluated in patients receiving aggressive chemotherapy (cisplatin administered 80-100 mg/m2 every 21 days) and in those receiving less aggressive chemotherapy (cisplatin administered 30-40 mg/m2 weekly) as part of the chemoradiation regimen.
In its goal to build a world-class clinical asset across the Brilacidin franchise, with the indication of severe OM a Company priority, Innovation Pharmaceuticals is preparing to seek scientific advice from the European Medicines Agency to round out European Union program requirements for Phase 3 clinical trials.
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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.
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