Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by inducing activation of p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In most cancers, regardless of origin, type, and location, the p53 pathway becomes inactivated (dysfunctional), thus preventing the body from performing its natural anti-tumor functions.
Conducted at the Dana-Farber Cancer Institute and at 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 currently is evaluating Kevetrin in an open-label, dose-escalation Phase 2a trial in Platinum-Resistant/Refractory Ovarian Cancer. Patients will receive more frequent dosing (three times per week) at higher starting levels (250 mg/m2) and will be subsequently followed while under standard of care cancer treatment. The estimated primary completion date for the study is December 31, 2017.
With a promising bioavailability profile, and to leverage its short half-life (the drug exits the body in approximately 8 to 10 hours), efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially even multiple times per day.
“What Cellceutix is doing with Kevetrin can lead to a groundbreaking moment in the world of oncology and is a vital key to the next generation of chemotherapy.”
— Dr. Emil Frei III
The FDA has awarded Kevetrin Orphan Drug status for Ovarian Cancer, Pancreatic Cancer, and Retinoblastoma, qualifying it for developmental incentives and an extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood Retinoblastoma.
Kevetrin is protected under a method of use patent.
Click on the links below for a more in-depth introduction to Kevetrin and Cellceutix's larger Cancer program.