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GSK announces launch of largest ever Phase III trial in lung cancer treatment

Chicago - June 5th, 2007 GlaxoSmithKline (GSK) today announced final results of a Phase II proof-of-concept clinical trial of its investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) in MAGE-A3 positive patients with stage IB or II Non-Small Cell Lung Cancer (NSCLC). These data were presented at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois, [Abstract No: 7554]. Final trial analysis showed a 27% reduction in the relative risk of cancer recurrence following surgery in patients treated with the MAGE-A3 ASCI, compared to placebo.

Final results from this trial confirm the positive interim results released last year at ASCO 2006, and support expanded testing of this novel cancer immunotherapy, said Paul A. Bunn Jr., M.D., James Dudley Endowed Professor of Oncology, Professor of Medicine and Director of the University of Colorado Cancer Center, Aurora, Colorado. This approach represents a potentially momentous shift in the cancer treatment paradigm. I believe we have only just scratched the surface of what is possible and look forward to seeing the results of the Phase III trial in due course.

Based on these encouraging data, GSK also announced today the opening of patient recruitment to the randomized and controlled Phase III efficacy and safety trial for this novel cancer immunotherapy; the largest clinical trial ever conducted in lung cancer treatment. MAGE-A3 ASCI will be evaluated as adjuvant therapy in about 2,270 MAGE-A3 positive patients with completely resected stage IB, II or IIIA NSCLC.

GSKs ASCIs aim to stimulate the patients own immune response to identify and attack cancer cells in a highly specific manner. This novel cancer immunotherapy is developed using tumor specific antigens, delivered as highly purified recombinant proteins, and GSKs own proprietary Adjuvant Systems, which are specifically designed to enhance ASCIs anti-tumor activity

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Contact: Andrea Long
andreal@wagged.com
202-326-0791
GlaxoSmithKline Biologicals
5-Jun-2007


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