Coley, Pfizer begin phase 3 trials of PF-3512676 for lung cancer

By Angela McDaniels

Seattle, Nov. 28 - Coley Pharmaceutical Group Inc. said it has begun two phase 3 clinical studies of PF-3512676 (CPG 7909, formerly ProMune) in first-line, non-small cell lung cancer under the special protocol assessment procedure of the U.S. Food and Drug Administration.

The studies, 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 1,600 patients with advanced non-small cell lung cancer.

The primary endpoint is overall survival, the company said.

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 agonist delivered by subcutaneous injection, for the treatment and control of cancers in humans.

Coley conducted a multi-center phase 2 clinical study of 112 patients that indicated a potential 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, the company said.

Coley is a biopharmaceutical company based in Wellesley, Mass., that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases, asthma and allergies.

Pfizer develops prescription medicines for humans and animals and is based in New York.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.