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Innovation Pharmaceuticals Provides Update on Kevetrin Program; Bridging Toxicology Efforts Aimed at Developing an Oral p53 Anti-Cancer Drug Candidate
BEVERLY, Mass., Oct. 22, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide a development update on the Company’s p53 anti-cancer drug candidate Kevetrin. The Company is in the process of selecting a Contract Research Organization to complete the necessary remaining bridging toxicology work toward developing Kevetrin in oral form, which remains the top priority within Innovation Pharmaceutical’s cancer program.
“After completing our Phase 1 Kevetrin study, we were invited by one of the world’s largest pharmaceutical companies to meet at their world headquarters and discuss our results,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “In attendance were the company’s CEO and senior scientists flown in from around the country. The main takeaways from the meeting were twofold. In order to enter into a development deal with them we needed to show p53 modulation in the tumor and develop a Kevetrin formulation as an oral dose. In our Phase 2a trial in ovarian cancer, intra-tumor p53 modulation was observed. Our goal now is to initiate a clinical trial of oral Kevetrin as soon as is feasible. Should clear efficacy be demonstrated, oral Kevetrin—as one of the few p53-modulating drugs in human trials, and in pill or tablet form—could emerge as a frontline treatment for cancer.”
“Independent academic cancer researchers, at Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, with whom we have closely collaborated over the years, are as intrigued as we are by Kevetrin’s considerable promise in treating multiple cancer types,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer of Innovation Pharmaceuticals. “We continue to advance Kevetrin, including efforts to complete the necessary tox studies. An orally-delivered Kevetrin could advantageously position the drug as a future go-to anti-cancer treatment, given that loss of proper p53 functioning is implicated in most cancers, and there is a strong patient preference for oral meds.”
Throughout pre-clinical testing and two successful clinical trials (Phase 1b for advanced solid tumors, Phase 2a for ovarian cancer), Kevetrin demonstrated promising signs of efficacy and a favorable pharmacokinetic profile, including a relatively short biological half-life (less than 2 hours). Preclinical research studies have revealed that Kevetrin exhibits a dose-dependent response in its effect upon cancer cells and clinical results have shown that it clears the body within one day—on average between 8 and 10 hours—though the drug can remain in the body up to roughly 24 hours, depending upon individual patient variations. In addition, oral bioavailability in tested animals is favorable.
The Company believes these characteristics make Kevetrin an ideal candidate for oral delivery—as the clinical dosing form—facilitating convenient and frequent administration, perhaps multiple times daily. Oral delivery would maximize the therapeutic benefit of the compound, whether administered as a monotherapy or in combination with other oncology drugs, including immunotherapies. Currently, pharmaceutical industry, as well as private investment, interest in this area is substantial—an estimated 500 million people alive today will die from p53 mutated cancers. A p53-modulating drug has yet to garner market approval.
The Company plans to provide further program updates once the Kevetrin toxicology studies conclude and oral formulation work commences. In the interim, more information on Kevetrin’s potential as a novel p53-modulating anti-cancer treatment can be found on the Company’s website at the links below:
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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 to Aspire Capital; 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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