On February 8, 2018 Innovation Pharmaceuticals Inc., (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported the closure of its Phase 2a clinical trial (see NCT03042702) of Kevetrin for the treatment of late-stage Ovarian Cancer (OC) (Press release, Innovation Pharmaceuticals, FEB 8, 2018, View Source [SID1234523838]). The Company initiated the trial for the purpose of demonstrating modulation of the key tumor-suppressor protein p53, which was achieved in analysis of the first patients at the lowest dose of Kevetrin (see December 27, 2017 press release).
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Throughout pre-clinical testing and two successful clinical trials, Kevetrin has demonstrated promising signs of efficacy as an anti-cancer agent and a favorable pharmacokinetic profile that includes a very short half-life and good bioavailability. It is believed that these characteristics make Kevetrin an ideal candidate for oral delivery (capsule or tablet), which will facilitate convenient and frequent dosing, perhaps even multiple times daily, to maximize the therapeutic benefit of the compound. With the positive observation of intra-tumor p53 modulation, the Company will now allocate resources to focus its efforts on completing development of an oral formulation, including performing bridging toxicology work.
The Company is adhering to a value-building strategy born from discussions with larger pharmaceutical companies interested in Kevetrin, one of the world’s most advanced p53 drug candidates. Securing the right development partner for Kevetrin remains an important objective.
"This study delivered multiple insights into how Kevetrin modulates the p53 protein and affects related molecular pathways," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "Moreover, if we successfully transition to oral dosing of Kevetrin, we believe the therapeutic effect will be maximized, providing important benefits to cancer patients in need—beyond the ultimate convenience of oral delivery. An effective orally-delivered p53-modulating drug has the potential to transform cancer care and we are proud to be at the forefront toward achieving this goal."
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 (see NCT01664000) of Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response (see ASCO (Free ASCO Whitepaper) 2015, ASCO (Free ASCO Whitepaper) 2013). Additional pre-clinical work supporting Kevetrin’s anti-cancer activity has recently been presented at scientific conferences (see EHA (Free EHA Whitepaper) 2017, AACR (Free AACR Whitepaper) 2017). The Company has initiated a Phase 2a trial of Kevetrin (see NCT03042702) in late stage, platinum-resistant/refractory ovarian cancer. Patients 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 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.