BEVERLY, Mass., Sep. 14, 2017 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals Inc., (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that a new clinical site has been added in the Company’s Phase 2 clinical trial of Kevetrin for ovarian cancer. The site, a renowned academic medical center, is now actively enrolling patients.
In the interventional study, Kevetrin, Innovation Pharmaceutical’s novel p53-modulating drug candidate, is being evaluated in patients with platinum-resistant/refractory ovarian cancer. The primary outcomes for the study are incidence of treatment-emergent adverse events and evaluation of changes in cancer pathway biomarkers and molecular signatures, as measured in tissue/tumor samples pre-treatment and after three weeks of treatment.
“What we and potential partners are extremely interested in is learning via tumor biopsies if Kevetrin is reaching its target and modulating pathways within the tumor that can deliver a clinically meaningful benefit; this would be a significant development in the p53/oncology dynamic,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “If that is indeed the case in any number of patients, we will have compelling evidence to move forward expeditiously. A next step would be to complete development of an oral formulation of Kevetrin, which is the preferred delivery method of patients and facilitates the potential for multiple daily doses.”
Initial preliminary study results are anticipated in 4th quarter 2017.
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 the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial evaluating Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response. Cellceutix has initiated a Phase 2a trial of Kevetrin in platinum-resistant/refractory ovarian cancer. Patients will receive more frequent dosing (3 times per week) at higher levels and then receive standard of care treatment after trial conclusion. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially even multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.