Myriad Pharmaceuticals, Inc. announced that the FDA has approved an Investigational New Drug (IND) application to begin a phase 1 clinical study with its Hsp90 inhibitor, MPC-3100, for the treatment of cancer.
The clinical development plan for MPC-3100 is designed to expedite the drug candidate through the clinical development path. The phase 1 trial will assess the safety and pharmacokinetics profile of MPC-3100. In preclinical testing, MPC-3100 has demonstrated potent anti-cancer activity in xenograft models of Her2+ breast cancer, myeloid leukaemia, lung cancer, prostate cancer, colon cancer, melanoma and gastric cancer.
"MPC-3100 shows tremendous potential for the treatment of a wide range of cancers," said Adrian Hobden, Ph.D., president of Myriad Pharmaceuticals, Inc. "The compound is the fifth new chemical entity to emerge from the company's internal discovery efforts and enter clinical study. We believe MPC-3100 will be an exciting addition to Myriad Pharmaceutical's clinical pipeline."
MPC-3100 is a novel, fully-synthetic, orally-bioavailable, small-molecule inhibitor of Heat shock protein 90 (Hsp90). Hsp90 regulates the activity of proteins and oncogenes which are known to control cell division, apoptosis, angiogenesis, metastasis and resistance to other cancer drugs. Inhibition of Hsp90 promotes the degradation of these cellular mediators of cancer and, thereby, inhibits tumour growth.
Hsp90 is a proven target for cancer treatment. Early natural product inhibitors of Hsp90 demonstrated activity in several human cancer clinical studies, including studies of Her2+ breast cancer, multiple myeloma and gastric cancers. However, these compounds have also demonstrated significant toxicity, which appears not to be related to inhibition of Hsp90. Unlike these molecules, MPC-3100 is a fully-synthetic, small molecule which is orally-bioavailable and has very encouraging, preclinical safety data.
Myriad Pharmaceuticals owns and controls all rights to MPC-3100 and is currently seeking a strategic partnership to maximize the value associated with the world-wide oncology market.
Myriad Pharmaceuticals is actively pursuing the development and commercialization of best-in-class and first-in-class therapeutic candidates in the areas of cancer and HIV. Myriad Pharmaceuticals currently has three additional drug candidates in human clinical trials (MPC-4326, Azixa, and MPC-9055). Myriad's lead oncology drug candidate, Azixa, is an exciting, novel small molecule compound with a proven in vivo anti-cancer activity which effectively penetrates the blood brain barrier and achieves drug levels in brain tissues that exceed 3000% of plasma levels. Azixa has completed two Phase 1 studies in which six of 66 patients had stable disease for between 5 and 16 months with no evidence of neurotoxicity. Azixa is currently in Phase 2 clinical trials for the treatment of primary glioblastoma and melanoma. MPC-4326 and MPC-9055 are small molecule drug candidates being developed for the treatment of HIV infection. Both molecules are maturation inhibitors and work against viral strains resistant to the commonly used anti-HIV medicines. MPC-4326 is expected to enter Phase 2b testing in the second half of 2009.
Myriad Pharmaceuticals, Inc. is currently a wholly owned subsidiary of Myriad Genetics, Inc. Myriad Genetics previously announced its intent to spin-off Myriad Pharmaceuticals as an independent, publically-traded company by the end of the second calendar quarter of 2009.
Myriad Genetics, Inc. is a leading healthcare company focused on the development and marketing of novel molecular diagnostic and therapeutic products.