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Two Phase 3 Clinical Studies of PF-3512676 Initiated as First-Line Treatment for Non-Small Cell Lung Cancer

WELLESLEY, Mass., Nov. 28 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced the initiation of two Phase III clinical studies of PF-3512676 (CPG 7909, formerly ProMune(TM)) in first-line non-small cell lung cancer (NSCLC) under the special protocol assessment ("SPA") procedure of the U.S. Food and Drug Administration.

The Phase III program, initiated under the direction of Coley's partner, Pfizer Inc., will evaluate PF-3512676 in combination with current standard-of- care chemotherapy regimens versus standard-of-care chemotherapy alone in the first-line treatment of patients with advanced non-small cell lung cancer. The primary endpoint for the Phase III clinical trials is overall survival. Each of the two Phase III clinical trials will enroll approximately 800 adult patients with Stage IIIb or IV disease.

In March 2005, Coley and Pfizer entered into an exclusive global license agreement to develop, manufacture and commercialize Coley's PF-3512676, a Toll-like receptor 9 (TLR9) agonist delivered by subcutaneous injection, for the potential treatment and control of cancers in humans. Coley conducted a multi-center Phase II clinical study of 112 patients in which results indicated the potential for a meaningful patient survival benefit among patients receiving PF-3512676 in combination with chemotherapy versus those who received chemotherapy alone for the first-line treatment of both of the major histologic subtypes of non-small cell lung cancer.

Source: Coley Pharmaceutical Group, Inc.

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