BEVERLY, Mass., Nov. 08, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide a corporate update highlighting business development and clinical pipeline priorities across its first-in-class drug candidates, Brilacidin, Prurisol and Kevetrin.
“A successful End-of-Phase 2 FDA meeting for our Brilacidin-Oral Mucositis asset, or positive results from our Phase 2b Prurisol trial in psoriasis—either outcome we believe would open up enormous possibilities for our shareholders,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “We look forward to updating shareholders on these, and other company developments, as we continue to lay a strong scientific foundation upon which future successes can be built.”
Corporate priorities, and upcoming events, include:
- Convening the End-of-Phase 2 meeting with the Food and Drug Administration (FDA) to discuss the expedited development of Brilacidin-Oral Mucositis. The meeting, scheduled for later this quarter, helps align with the FDA on clinical trial design and other program requirements.
- Analyzing Prurisol topline results in Psoriasis once full payment can be made to the Contract Research Organization (CRO) based on amounts owed, which were, in part, more than budgeted due to significant cost overruns. A partial payment was recently made, with additional payments planned.
- Selecting a CRO to complete the necessary remaining bridging toxicology work, approximately half of which has been completed, toward developing Kevetrin (our p53-modulating anti-cancer drug) in oral formulation and commencing its next clinical trial. As Kevetrin is not cytotoxic, the possibility exists for an oral version of Kevetrin to commence a Phase 1/1b study in healthy subjects, followed by a Phase 2 study—shortening the development timeline significantly.
- Continuing to advance partnership discussions, with our primary objective to complete licensing deals that provide access to non-dilutive capital to move our clinical assets forward in the most expeditious and cost-effective manner.
- Manufacturing Brilacidin final drug substance/drug product for a future, and potentially pivotal, Oral Mucositis clinical trial and, more broadly, for the bulk production of commercial-grade drug supply. The Company has already paid contracted vendors over $1 million toward project completion.
- Presenting a scientific poster on Brilacidin for Inflammatory Bowel Disease (IBD) at the “IBD Innovate 2018” conference sponsored in part by the Crohn’s & Colitis Foundation and held in New York City. The poster will be available in the Events and Presentations section of the Company website on November 13, 2018.
- Expanding the Company’s Intellectual Property when appropriate, as was recently completed in relation to Brilacidin—the U.S. Patent & Trademark Office announcing allowances directed to oral, buccal, and sublingual pharmaceutical compositions of the drug.
- Developing an oral formulation of Brilacidin to treat more extensive forms of IBD (e.g., Ulcerative Colitis and Crohn’s Disease) and a topical formulation of Brilacidin for Inflammation and Immunology (I&I) conditions (e.g., Atopic Dermatitis and Acne), in preparation for subsequent 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. 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. Prurisol, an oral psoriasis drug candidate acting through immune modulation and PRINS reduction, has now completed a Phase 2b trial and is awaiting statistical analysis. 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, our future drug development plans, other statements regarding future product developments, 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.