Clinical Trials For PF-3512676 Combined With Cytotoxic Chemotherapy Stopped
PF-3512676 Combined With Cytotoxic Chemotherapy
Pfizer, the parner of Coley Pharmaceutical Group, has discontinued the development program in lung cancer for PF-3512676, an investigational compound, in combination with cytotoxic chemotherapy.
This includes two Phase 3 clinical trials and two Phase 2 clinical trials.
A scheduled interim analysis of the Phase 3 clinical trials by an independent Data Safety Monitoring Committee (DSMC) showed that there was no evidence that PF-3512676 produced additional clinical efficacy over that achieved with the standard cytotoxic chemotherapy regimen alone. The DSMC concluded that the risk-benefit profile did not justify continuation of the trials.
"This news is surprising based on the signs of clinical activity observed with PF-3512676 in Coley's Phase II randomized clinical trial and we are disappointed with this setback in the program," said Robert L. Bratzler, Ph.D., President and Chief Executive Officer of Coley Pharmaceutical Group. "We remain focused on advancing our portfolio of TLR Therapeutic candidates for the treatment of cancer, allergy and asthma, lupus and rheumatoid arthritis, and as a vaccine adjuvant, including novel small molecules and RNA- based drugs targeting TLRs7, 8 and 9."
Coley will be hosting a conference call and webcast today, Wednesday, June 20, 2007 at 4:30 p.m. U.S. Eastern Daylight Time with company management to discuss this development.