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Published on 6/6/2006 in the Prospect News Biotech Daily.

GlaxoSmithKline says MAGE-A3 reduces relative cancer risk by 33%

By Lisa Kerner

Charlotte, N.C., June 6 - GlaxoSmithKline said patients treated with its investigational MAGE-A3 Antigen Specific Cancer Immunotherapeutic (ASCI) in non-small cell lung cancer (NSCLC) experienced a one-third reduction in relative risk of cancer recurrence following surgery, compared to a placebo.

All the subjects in the proof-of-concept, randomized, double-blind phase 2 clinical trial had tumors expressing a tumor-specific antigen known as MAGE-A3, which is present in about 35% to 50% of early NSCLC, the most common form of lung cancer.

While not statistically significant, the 33% reduction in relative risk of cancer recurrence warrants continued investigation, according to a company news release.

The results from an interim analysis were presented at the 2006 American Society of Clinical Oncology annual meeting in Atlanta.

Two of the182 patients were withdrawn from the trial due to adverse events. The most commonly reported adverse events were mild local or systemic reactions.

GlaxoSmithKline said the pre-planned interim analysis was performed at a median follow-up of 21 months, at which point 30.3% of patients receiving MAGE-A3 ASCI had relapsed, compared to 41.7% of patients receiving a placebo.

"These first results obtained with our MAGE-A3 ASCI reinforce our belief in the potential application of the ASCI approach in the treatment of cancer," GlaxoSmithKline Biologicals president Jean Stephenne said in the release.

Final results are expected to be available later this year, with phase 3 trials slated to begin in early 2007.

GlaxoSmithKline is a research-based pharmaceutical and health care company based in Philadelphia.


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