Our lead programs focus on two families of compounds with related but distinct mechanisms of action. The first and most advanced is a NADH oxidase inhibitor program that includes Phenoxodiol, a first-generation compound that has been well tolerated in hundreds of patients, and a next-generation compound called ME-143. ME-143 in particular has demonstrated superior anti-tumor activity against a broad range of tumor cell lines. Our Investigational New Drug (IND) application for ME-143 has been approved by the U.S. Food and Drug Administration (FDA) and we initiated a Phase I clinical trial in September 2011.
The second program is a family of novel mitochondrial inhibitors. The first-generation compound NV-128 has shown activity in pre-clinical models against a broad range of major cancers, including chemotherapy-resistant ovarian and KRAS-mutant, Tarceva-resistant non-small cell lung cancer cell lines. NV-128 is the prodrug of our lead mitochondrial inhibitor drug candidate ME-344, which has been shown to be significantly more potent than NV-128 in pre-clinical studies. We plan to complete the required pre-clinical studies of ME-344 to submit an IND application to the FDA by the first quarter of 2012.
Our most advanced program is a family of NADH oxidase inhibitors that demonstrate robust anti-tumor activity against a broad range of tumor cell lines.
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Our mitochondrial inhibitors have shown activity in both chemotherapy-resistant ovarian and KRAS mutant, Tarceva-resistant NSCLC cell lines.
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