LOUISVILLE, Colo., April 3, 2013 – GlobeImmune, Inc., announced today the initiation of a Phase 2 clinical trial at the National Cancer Institute (NCI) to evaluate GI-6207 in subjects with medullary thyroid cancer (MTC). Ravi A. Madan, M.D., at the NCI Medical Oncology / Laboratory of Tumor Immunology and Biology is the Principal Investigator for this study. GI-6207 is being developed as part of a Collaborative Research and Development Agreement between the NCI and GlobeImmune.
GI-6207-02 is a randomized Phase 2 study that is planned to enroll a total of 34 patients in a cross-over trial design. Patients will be treated with either GI-6207 for one year or be observed for six months and then treated with GI-6207 for one year. The primary endpoint for the trial will be the effect of GI-6207 on changes in calcitonin levels after six months of GI-6207 treatment vs. observation. Calcitonin is a tumor marker that correlates with tumor size in MTC. Elevated calcitonin values after surgery indicate persistent or recurrent disease.
“We believe that MTC is an excellent clinical indication for Tarmogen® immunotherapy,” said David Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. “Observation is the current standard of care for minimally symptomatic MTC with low tumor burden. However, in this setting we believe we will be able to evaluate GI-6207-induced immune responses and potentially correlate them with calcitonin levels in a short time frame.”
Medullary Thyroid Cancer
Thyroid cancer is the most common type of endocrine malignancy in the U.S. with approximately 56,000 new cases in 2012. MTC, a subtype of thyroid cancer, is aggressive, spreads quickly and has a poor prognosis, with approximately 25 percent and 10 percent of patients alive at five and ten years, respectively. Surgery is currently the only curative treatment for MTC. Two drugs have been approved for the treatment of metastatic MTC. Both of these products were approved on the basis of improved progression free survival; neither has yet shown improved overall survival. Both of these products have significant side effect profiles that include hypertension, nausea, diarrhea, cardiac arrhythmias and thrombotic or bleeding episodes.
GI-6207
The GI-6207 Tarmogen consists of whole, heat-killed, recombinant S. cerevisiae yeast genetically engineered to express a modified version of the human carcinoembryonic antigen (CEA) protein as the target cancer antigen. CEA is over-expressed in multiple human epithelial cancers, including MTC, where CEA is almost universally expressed and is a diagnostic marker of the disease. Preclinical studies have shown that GI-6207 can induce an immune response to CEA as well as therapeutic anti-tumor responses. A previous Phase 1 study of monotherapy GI-6207 demonstrated preliminary safety and tolerability, enhanced immune responses and stable disease in 20% of subjects (5/25) beyond 3 months.
About GlobeImmune
GlobeImmune is a biopharmaceutical company focused on developing products for the treatment of cancer and infectious diseases based on its proprietary Tarmogen platform. Tarmogens activate the immune system by stimulating cellular immunity, known as T cell immunity, in contrast to traditional vaccines that predominately stimulate antibody production. To date, Tarmogen product candidates have been generally well tolerated in clinical trials for multiple disease indications and are efficient to manufacture. In May 2009, the company entered into a collaboration agreement with Celgene Corporation focused on the discovery, development and commercialization of product candidates for the treatment of cancer. In October 2011, the company entered into a worldwide, strategic collaboration with Gilead Sciences, Inc., to develop Tarmogens for the treatment of chronic hepatitis B infection. For additional information, please visit the company’s website at www.globeimmune.com.
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Safe Harbor Statement
This press release contains “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential for GI-6207 to target medullary thyroid cancers expressing CEA and Tarmogen’s potential side effect profiles, the Company’s ability to successfully complete clinical trials, timing and eventual prospects for approval to market any of the Company’s products and the prospects for the Company’s collaborations. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. The Company disclaims any intent or obligation to update these forward-looking statements.