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news.Third new Tarmogen product candidate to enter human clinical trials over the last four years
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US-based GlobeImmune has initiated a Phase I clinical trial to investigate the safety and tolerability of a new Tarmogen, GI-6207, in patients with metastatic cancers that over-express carcinoembryonic antigen. This is the third new Tarmogen product candidate to enter human clinical trials over the last four years, the company said.
The GI-6207-01 study is an open-label, dose-escalation trial. The primary endpoint of the study is the safety and tolerability of escalating doses of GI-6207. Secondary endpoints include levels of carcinoembryonic antigen (CEA)-specific T cells, reduction in CEA serum markers and circulating tumor cells and evidence of clinical benefit.
James Gulley, director of the clinical trials group, Laboratory of Tumor Immunology and Biology, National Cancer Institute (NCI), will be the principal investigator for the study. This will be a single center Phase I study funded by the NCI.
Timothy Rodell, president and CEO of GlobeImmune, said: Tarmogens are designed to activate the immune system to recognize and attack cells with disease-specific characteristics such as the over-expression of CEA. This trial will build on our previous data with GI-4000 targeting mutated Ras in pancreas and colon cancers and, if successful, allows us to broaden the range of molecular targets for the Tarmogen platform.