On September 8, 2020 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported 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) (Press release, Innovation Pharmaceuticals, SEP 8, 2020, View Source [SID1234564737]). AML accounts for approximately one-quarter to one-third of all leukemias worldwide and has a 5-year survival rate of only 24 percent.

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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 apprised 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.

· Napolitano R, et al. "Kevetrin Induces Apoptosis in TP53 Wild‑Type and Mutant Acute Myeloid Leukemia Cells." Oncol Rep. 2020 Oct; 44(4): 1561–1573.
View Source
View Sourcepdf/or-44-04-1561.pdf (pdf)

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.