Coley Pharmaceutical Group, Inc. announced that Pfizer Inc. has now completed target patient enrolment in two, pivotal phase III clinical trials of the Toll-like receptor 9 (TLR9) agonist drug candidate, PF-3512676, for the treatment of advanced non-small cell lung cancer (NSCLC). A combined total of more than 1,600 patients with Stage IIIB/IV disease are enrolled in these trials.

Coley and Pfizer entered into an exclusive global license agreement in March 2005 to develop, manufacture and commercialize Coley's TLR9 agonist compound for the potential treatment, control and prevention of cancers in humans. In November 2005, Pfizer commenced patient enrolment in two Phase III clinical trials for patients with advanced NSCLC. Both trials are being conducted under the Special Protocol Assessment ("SPA") procedure of the US Food and Drug Administration.

Each of the randomized, controlled Phase III clinical trials is assessing the efficacy and safety of PF-3512676 administered in combination with standard-of-care chemotherapy as first-line treatment in patients with locally advanced or metastatic NSCLC as compared to chemotherapy alone. The primary endpoint for each trial is overall survival. The first of the Phase III clinical trials compares gemcitabine/cisplatin with and without PF-3512676; and target patient enrolment of 800 patients was achieved by Pfizer in December 2006. The second Phase III clinical trial compares carboplatin/paclitaxel chemotherapy with and without PF-3512676; the target patient enrolment of 800 patients was achieved in April 2007.

Worldwide, lung cancer is the most commonly diagnosed cancer, and in the United States, it is the leading cause of cancer deaths for both men and women. Lung cancers are comprised mainly of two types: small cell lung cancer and NSCLC. NSCLC accounts for approximately 80 percent of all lung cancer. Current treatments for lung cancer include surgery, chemotherapy, and radiation, as well as targeted therapies like antibodies and small molecules. The current standard of care in the United States and Europe for first-line treatment of Stages IIIB and IV NSCLC includes a combination of two chemotherapy drugs; it has historically resulted in a median overall survival of 7 to 10 months.