Tuesday, March 25, 2008

GlobeImmune Initiates Phase IIa GI-4000 NSCLC Study

GlobeImmune initiated a Phase IIa trial to evaluate their GI-4000 Tarmogen® for the treatment of non-small cell lung cancer (NSCLC) patients with tumors having mutations in the ras gene. NSCLC patients with tumors positive for mutated ras may have a worse survival compared to patients with other NSCLC types and therefore these patients may not benefit from treatment with selective tyrosine kinase inhibitors. This clinical trial will explore treatment with patients based on the results of a panel of molecular tests, including EGFR mutation status, ERCC1 expression levels, and ras mutation status. The GI-4000 trial is designed to study safety, immune responses, and clinical benefit, patients will receive GI-4000 for up to 3 years with the goal of delaying disease recurrence and prolonging survival.

GI-4000 is a Tarmogen® intended to generate an immune response to cells containing the seven most common mutations in the ras oncogene product. Mutations in ras are believed to be responsible for over 150,000 cases of cancer annually in the US, including pancreas, NSCLC, colorectal, ovarian and other cancers. In a Phase I study of advanced pancreas and colorectal cancer patients, GI-4000 was well-tolerated across the full range of doses tested. A multi-center, randomized, placebo-controlled Phase II trial of GI-4000 in combination with gemcitabine in resected pancreas cancer patients is ongoing.

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