August 24, 2007
Ascenta Therapeutics Presents New Clinical Data on AT-101 for the Treatment of Hormone-Refractory Prostate Cancer
Washington, DC, August 24, 2007
Ascenta Therapeutics Inc., today announced new clinical and preclinical data on its Phase 2 compound, AT-101, at the Sixth Annual Congress on targeted Therapies in Cancer, held August 24th-26th in Washington, DC.
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-naïve 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.