Innovation Pharmaceuticals Announces Publication of Independent Research on Kevetrin, the Company's p53 Drug Candidate, in Oncology Reports
BEVERLY, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce the publication of independent research, in Oncology Reports, a leading oncology journal, supporting the therapeutic potential of Kevetrin, the Company’s p53-modulating anti-cancer drug candidate, in treating Acute Myeloid Leukemia (AML). AML accounts for approximately one-quarter to one-third of all leukemias worldwide and has a 5-year survival rate of only 24 percent.
In the recently published Kevetrin AML research, linked below, Kevetrin treatment was shown to arrest cell growth and cause cell death (apoptosis) in AML cells. Multiple p53 targets, several cellular processes and oncogenic pathways were also shown to be positively impacted by Kevetrin. Kevetrin was further shown to exhibit preferential cytotoxic activity against leukemia blast cells, while largely not affecting the immune microenvironment, supporting a less toxic drug profile.
The researchers concluded: “These findings suggest that Kevetrin may be a promising therapeutic option for patients with both wild-type and TP53-mutant AML.”
“These compelling research findings, by independent researchers, confirm Kevetrin’s treatment potential in AML—a serious blood cancer in great need of novel treatments,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “A Phase 2a clinical trial of Kevetrin in late-stage platinum-resistant ovarian cancer revealed intra-tumor p53 modulation. The Company is planning to formulate Kevetrin for oral delivery, leveraging drug pharmacokinetics and enhancing ease of use. These new published findings provide valuable insights into Kevetrin’s anti-cancer properties.”
As a gene-based therapy, should Kevetrin demonstrate efficacy in clinical testing, its regulatory pathway to approval might be expedited. The Food and Drug Administration (FDA) has signaled strong support for development of gene therapies. Two gene therapies for cancers of the blood (Kymriah and Yescarta) were approved for genetically-driven diseases based primarily on results from mid-stage, single-arm, open-label clinical trials. FDA’s efficacy determination for Kymriah was based on 92 evaluable patients, and 108 evaluable patients for Yescarta.
The Company will keep shareholders aprised of developments in our Kevetrin program. In separate news, the Company will be submitting a briefing package shortly to the FDA in preparation for our planned clinical study of Brilacidin for COVID-19.
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About Kevetrin and p53
Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by modulating p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In a majority of cancers, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Kevetrin, by intravenous dosing, has successfully completed a Phase 1 clinical trial in advanced solid tumors and a Phase 2a clinical trial in late-stage ovarian cancer. The company plans on completing oral toxicology studies and changing the dosing to an oral formulation (tablet or capsule), subject to available financial resources. The Food and Drug Administration (FDA) has awarded Orphan Drug status for Kevetrin in ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and market exclusivities upon any future regulatory approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.
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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 (UP/UPS). 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 Infection. Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated as a potential treatment for COVID-19. 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 our future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other coronaviruses, 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 but not limited to risks related to conducting pre-clinical studies and seeking IND regulatory approval for Brilacidin and Kevetrin clinical trials; that prior test results may not be replicated in future studies and trials, 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 licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or 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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