GlobeImmune initiates Phase IIa lung cancer trial

[RandyW]

GlobeImmune initiates Phase IIa lung cancer trial

19th March 2008

By Staff Writer

GlobeImmune has started a Phase IIa clinical trial at Memorial Sloan Kettering Cancer Center to evaluate the company's GI-4000 Tarmogen for the treatment of non-small cell lung cancer patients with tumors having mutations in the ras gene.

GI-4000-03 is a an open-label consolidation therapy trial sponsored by Memorial Sloan Kettering Cancer Center (MSKCC) to evaluate the GI-4000 Tarmogen (targeted molecular immunogen) in subjects with non-small cell lung cancer (NSCLC) treated with curative intent, whose tumor is found to contain a mutation in the ras gene and who are disease free at their first post-treatment re-staging assessment (one-four months after completion of therapy).

The GI-4000-03 trial is designed to study safety, immune responses, and clinical benefit. Patients will receive GI-4000 for up to three years with the goal of delaying disease recurrence and prolonging survival.

Christopher Azzoli, principal investigator for the Phase IIa study at MSKCC, said: "MSKCC has a research program which treats NSCLC patients with adjuvant chemotherapy based on the results of a panel of molecular tests, including EGFR mutation status, ERCC1 expression levels, and ras mutation status. We are excited to explore the potential of GI-4000 to improve clinical outcomes in this difficult to treat patient population."