Innovation Pharmaceuticals European Subsidiary, IPIX Pharma Ltd., Granted Meeting with European Medicines Agency (EMA) to Discuss International Phase 3 Brilacidin Oral Mucositis Program
BEVERLY, Mass., March 28, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (IPIX) (“the Company”), a clinical stage pharmaceutical company, announced today that the European Medicines Agency (EMA) has granted a meeting with the Company’s European subsidiary, IPIX Pharma Ltd., to discuss a briefing package submitted for Scientific Advice regarding the clinical development program of Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
The purpose of such meetings is for the EMA to provide guidance on the appropriate tests and studies in the development program for a medicine. Receiving formal scientific advice helps ensure health authority alignment regarding appropriate testing to support an eventual marketing-authorization application in Europe.
The meeting with IPIX Pharma has been scheduled by EMA for mid-April 2019 and will serve to complement the regulatory feedback and advice obtained by the Company from the already completed End-of-Phase 2 Meeting held with the U.S. Food and Drug Administration (FDA). At this meeting, an acceptable Phase 3 development pathway was agreed upon by the FDA and the Company to advance Brilacidin for the prevention of SOM in HNC.
“We are extremely pleased to have been granted this scientific meeting with the EMA, particularly in such rapid fashion,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “New and effective treatments that not only help mitigate, but actually prevent the occurrence of oral mucositis, have been long sought-after. Currently there is no approved drug to decrease the incidence of Severe Oral Mucositis in Head and Neck Cancer. We look forward to advancing Brilacidin toward potential regulatory approval, both in Europe and the United States, as we refine key aspects of our planned Phase 3 program in oral mucositis.”
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-OM, 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.
http://www.ipharminc.com/new-blog/2018/9/24/b...l-om-drugs
About Brilacidin and Severe Oral Mucositis
There currently are no FDA-approved drugs to decrease the incidence of Severe OM (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and on a worldwide basis, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop SOM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval.
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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, 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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