Coley Announces Completion of Enrollment in Two NSCLC Studies

Coley Pharmaceutical has announced that Pfizer has completed target patient enrollment 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 total of more than 1,600 patients with Stage IIIB/IV disease have been enrolled in the 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 began patient enrollment in two Phase III clinical trials of patients with advanced NSCLC. Both trials are being conducted under the FDA's special protocol assessment procedure, Coley said.

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 with chemotherapy alone.

The primary endpoint for each trial is overall survival. The first trial compares gemcitabine plus cisplatin with and without PF-3512676, and a target patient enrollment of 800 patients was achieved by Pfizer in December 2006. The second Phase III trial compares carboplatin plus paclitaxel chemotherapy with and without PF-3512676, and the target patient enrollment of 800 patients was achieved this month.

PF-3512676 is one of a new class of investigational synthetic agonists for TLR9 that direct the immune system to attack malignant cells, resulting in a highly targeted therapeutic effect. Through TLR9, the drug activates plasmacytoid dendritic cells and B cells to reverse immune tolerance to malignant cells and to drive specific, sustained anti-tumor responses through the production of antigen-specific cytotoxic T cell lymphocytes and antibodies.