GlobeImmune Initiates Phase 1 Clinical Trial With NCI in CEA Over-Expressing Cancers
- Category: Vaccines
- Published on Thursday, 16 April 2009 03:00
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GlobeImmune announced the initiation of a Phase 1 clinical trial to investigate the safety and tolerability of a new Tarmogen, GI-6207, in patients with metastatic cancers that over-express carcinoembryonic antigen (CEA)
LOUISVILLE, CO, USA | April 16, 2009 | GlobeImmune, Inc. today announced the initiation of a Phase 1 clinical trial to investigate the safety and tolerability of a new Tarmogen, GI-6207, in patients with metastatic cancers that over-express carcinoembryonic antigen (CEA). This is the third new Tarmogen® product candidate to enter human clinical trials over the last four years.
James L. Gulley, M.D., Ph.D., F.A.C.P., Director of the Clinical Trials Group LTIB at the National Cancer Institute (NCI), will be the Principal Investigator for the study. This will be a single center Phase 1 study funded by the NCI.
The GI-6207-01 study (NCI CTEP #8187) 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 CEA-specific T cells, reduction in CEA serum markers and circulating tumor cells and evidence of clinical benefit.
"Tarmogens are designed to activate the immune system to recognize and attack cells with disease-specific characteristics such as the over-expression of CEA," said Timothy Rodell, M.D., President and CEO of GlobeImmune. "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. We are excited to be working with Dr. Gulley and his colleagues at the NCI on this program."
The GI-6207 Tarmogen consists of whole, heat-killed, recombinant S. cerevisiae yeast, genetically modified to express CEA protein. CEA represents an important target for cancer therapies as it is over-expressed in more than 90 percent of colorectal, gastric and pancreas cancers; 70 percent of non-small cell lung cancers; and 50 percent of breast cancers.
Last year, GlobeImmune signed a Cooperative Research and Development Agreement (CRADA) with NCI and the National Institutes of Health to jointly develop multiple product candidates intended to treat a variety of cancers. CEA is the first cancer antigen to be targeted in human trials through this collaboration.
GlobeImmune is a private company developing targeted molecular immunogens (Tarmogens) for the treatment of cancer and infectious diseases. GlobeImmune has two products in randomized Phase 2 clinical trials. GI-5005 is being evaluated in patients with chronic hepatitis C infection, as both a front-line therapy in combination with standard of care, and as a monotherapy for second line salvage in interferon intolerant patients. GI-4000 is being evaluated in patients with pancreas, lung and colorectal cancers caused by mutations in the Ras oncogene product. To date, Tarmogens have been generally well-tolerated, and shown to generate antigen-specific T cell immune responses and improved clinical outcomes in patients.