Coley Pharmaceutical Group Announces Completion Of Patient Enrollment In Pfizer's Two Pivotal Phase III NSCLC Clinical Trials

Main Category: Lung Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 12 Apr 2007 - 0:00 PDT

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Coley Pharmaceutical Group, Inc. (Nasdaq: COLY) today announced that Pfizer Inc. (NYSE: PFE) has now 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 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 enrollment 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 U.S. 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 enrollment 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 enrollment of 800 patients was achieved in April 2007.

About Non-Small Cell Lung Cancer

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.

About Coley Pharmaceutical Group

Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, asthma and allergic disorders and to enhance the effectiveness of vaccines. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoSmithKline and the United States government. For further information on Coley Pharmaceutical Group please visit http://www.coleypharma.com.

Safe Harbor Statement

Certain statements in this news release concerning Coley's business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the future clinical development of PF-3512676. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; the risk that results from early stage clinical trials may not be indicative of results in later stage trials; the unproven safety and efficacy of products under development; intellectual property rights and litigation; competitive products; and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

Coley Pharmaceutical Group, Inc.
http://www.coleypharma.com

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