Ascenta Therapeutics Presents New Clinical Data on AT-101 for the Treatment of Hormone-Refractory Prostate Cancer
Data presented were from the Phase 1 portion of an ongoing, open-label Phase 1/2 clinical study of AT-101 in combination with docetaxel and prednisone in men with hormone-refractory-prostate cancer (HRPC). The Phase 1 component of this multi-center study was designed to assess the safety and optimal dosing of the oral, pan-Bcl-2 inhibitor AT-101 when given in combination with docetaxel and prednisone, in preparation for Phase 2 study in a larger group of patients.
AT-101 is the only orally bioavailable pan-Bcl-2 inhibitor currently under clinical investigation. With inhibitory activity against Bcl-2 family proteins Bcl-2, Bcl-XL and Mcl-1, AT-101 acts to induce programmed cell death (apoptosis) of cancer cells which commonly rely on these anti-apoptotic proteins to survive.
Preliminary data from the study indicate that AT-101 has biological activity in combination with docetaxel and prednisone in men with HRPC. Eight of nine chemotherapy-naive patients (89%) treated in the Phase 1 portion of the trial achieved a 50% Partial Response, per the accepted (Bubley) criteria, of the tumor marker Prostate Specific Antigen (PSA), and all nine achieved a 30% drop in PSA levels. No dose-limiting toxicities were observed for any patient in the study.
"These results are encouraging with regards to the use of AT-101 in combination with the approved docetaxel/prednisone regimen for the treatment of HRPC," said Dr. Jon T. Holmlund, Chief Medical Officer of Ascenta. "The safety data with the combination indicate that it is appropriate for Phase 2 study, and the early response data suggest that AT-101 may be effective in the treatment of HRPC when used in combination with docetaxel and prednisone."
Founded in 2003, Ascenta is a privately-held biopharmaceutical company that discovers and develops targeted new medicines for the treatment of cancer. The company has offices in San Diego, California and Malvern, Pennsylvania, and a preclinical research facility in Shanghai, China. Ascenta's technology is focused on discovering molecules that hit vulnerable targets in endogenous apoptosis pathways and shut down cell growth and proliferation in cancer cells. Ascenta's broad pipeline of compounds is licensed from both the National Institutes of Health and the laboratory of Dr. Shaomeng Wang at the University of Michigan.
For additional information on Ascenta Therapeutics, please visit the company's website at www.ascenta.com
Ascenta Therapeutics Inc.
Mark Benedyk PhD
Vice President, Business Development
Posted: August 2007