J Vincent Njar, Ph.D., professor and Angela Brodie, Ph.D., professor, cancer researchers at the University of Maryland School of Medicine Department of Pharmacology, have been issued several patents that cover their invention VN/124- (also known as TOK-001 and Galeterone) and related compounds technology.
The technology of VN/124-1 and related compounds has been licensed by University of Maryland, Baltimore (UMB) to Tokai Pharmaceuticals, Inc. in Cambridge, MA, who are currently developing the technology via clinical trials in castration resistant prostate cancer (CRPC) patients. Tokai recently completed ARMOR1, a Phase 1 proof of-concept study of Galeterone in patients with CRPC, part of the ARMOR (Androgen Receptor Modulation Optimized for Response) clinical development program, and are now initiating a Phase 2 clinical trial in patients with CRPC.
Results from the ARMOR1 clinical trial were presented at the American Association for Cancer Research (AACR) Annual Meeting 2012 and the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO), showing that Galeterone demonstrated efficacy and was well-tolerated in patients with CRPC.
On the basis of promising phase I studies, Tokai recently announced that Galeterone (TOK-001) has received Fast Track designation from the U.S. Food and Drug Administration FDA) for the potential treatment of CRPC.