Coley Pharmaceutical Group's Vaccine Adjuvant, VaxImmune, To Enter Phase III Clinical Testing

Main Category: Lung Cancer
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 06 Jun 2007 - 0:00 PDT

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Coley Pharmaceutical Group, Inc. (Nasdaq: COLY) today announced that its vaccine adjuvant, VaxImmune(TM), will be evaluated in a Phase III clinical trial as part of GlaxoSmithKline's (GSK) MAGE-A3 cancer immunotherapeutic in patients with early stage, completely resected non-small cell lung cancer (stage IB, II or IIIA NSCLC). This will be Coley's second Toll-like receptor 9 (TLR9) agonist drug candidate to be studied in Phase III clinical trials for the treatment of NSCLC.

GSK's Phase III trial will evaluate MAGE-A3 ASCI as adjuvant therapy in MAGE-A3 positive patients with NSCLC. MAGE-A3 is a tumor-specific antigen that is expressed in a variety of cancers, including NSCLC, with no expression in normal cells. Expression of the MAGE-A3 gene has been observed in testicular cells but without antigen presentation capabilities.

GSK's ASCI represents a novel class of medicines designed to train the immune system to recognize and eliminate cancer cells in a highly specific manner. These cancer immunotherapeutics combine tumor antigens, delivered as purified recombinant proteins, and GSK's proprietary Adjuvant Systems which are specific combinations of immunostimulating compounds selected to increase the anti-tumor immune response. VaxImmune is one of the components of the GSK proprietary Adjuvant System which will be used in the MAGE-A3 ASCI evaluated in the Phase III trial.

VaxImmune is a proprietary TLR9 agonist designed to induce both an enhanced antibody response and a potent killer T cell immune response to vaccines against infectious diseases or cancer in order to achieve and sustain a clinical response without compromising safety. Coley has granted GSK worldwide licenses for the use of VaxImmune in GSK's vaccines in development for certain cancers and infectious diseases.

The GSK Phase III clinical trial which was announced today will target enrollment of about 2,270 patients. The randomized, double-blind, and placebo- controlled MAGRIT trial (MAGE-A3 as Adjuvant Non-Small Cell Lung Cancer Immunotherapy) will enroll patients with stage IB, II or IIIA resectable NSCLC. The MAGE-A3 ASCI administration will be initiated in two groups of patients: after surgery and standard chemotherapy in one group of patients and after surgery in patients who are not receiving chemotherapy. The primary endpoint of the trial is disease-free survival.

The initiation of this Phase III clinical trial will trigger a milestone payment to Coley.

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, allergy and asthma 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, GlaxoSmithKline, Merck, Novartis Vaccines 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 those relating to the initiation of the Phase III MAGRIT trial. 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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