Tokai Pharmaceuticals, Inc.
About Tokai Pharmaceuticals Inc.
Tokai Pharmaceuticals is a privately held U.S. biopharmaceutical company based in Cambridge, MA, focused on developing new treatments for prostate cancer. Tokai Pharmaceuticals is backed by Apple Tree Partners and Novartis Venture Fund and has raised a total of $57 million to date.
The company's lead drug candidate, galeterone, is the first investigational new drug that can decrease overall androgen receptor levels in prostate tumors and in which three distinct mechanisms of action are combined in one drug. Galeterone is currently in clinical development and is being studied in patients with castration resistant prostate cancer (CRPC).
Galeterone Development Program
In preclinical studies, galeterone has demonstrated a novel MOA acting in three distinct ways to treat prostate cancer: as an androgen receptor antagonist, as a CYP17 lyase inhibitor and by decreasing overall androgen receptor levels in prostate cancer cells. Galeterone is the only drug in development shown to exhibit all three of these properties.
Galeterone is currently in clinical development for the treatment of CRPC. ARMOR1 (Androgen Receptor Modulation Optimized for Response), a Phase 1 proof-of-concept dose-escalation study evaluating the safety and efficacy of once-daily galeterone treatment in men with CRPC, was completed in June of 2011; however, patients have continued in extension up to 22 months on therapy. Forty-nine men with metastatic and non-metastatic chemotherapy-naïve CRPC were enrolled in the ARMOR1 study; positive results from the trial are being presented at a scientific meeting in 2012.
The company will now take the compound into a robust Phase 2 in 2012 and then a pivotal study to determine safety and efficacy.