SOURCE: GlobeImmune, Inc.

March 19, 2008 07:00 ET

GlobeImmune Announces Initiation of a Phase 2a Clinical Trial of GI-4000 in Patients With Non-Small Cell Lung Cancer at Memorial Sloan Kettering

LOUISVILLE, CO--(Marketwire - March 19, 2008) - GlobeImmune, Inc. announced today the initiation of a Phase 2a clinical trial at Memorial Sloan Kettering Cancer Center (MSKCC) to evaluate GlobeImmune's GI-4000 Tarmogen® for the treatment of non-small cell lung cancer (NSCLC) patients with tumors having mutations in the ras gene.

Molecular profiling of NSCLC tumors

"NSCLC patients with tumors positive for mutated ras have a worse survival compared to patients with other NSCLC types in the setting of traditional therapy," said Dr. Christopher G. Azzoli, Principal Investigator for the Phase 2a study at MSKCC. "Furthermore, these patients may not benefit from treatment with selective tyrosine kinase inhibitors. Better treatments for lung cancer with mutated ras are greatly needed. 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."

About the GI-4000-03 clinical trial

GI-4000-03 is a an open-label consolidation therapy trial sponsored by MSKCC to evaluate the GI-4000 Tarmogen (targeted molecular immunogen) in subjects with non-small cell lung cancer 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 (1-4 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 3 years with the goal of delaying disease recurrence and prolonging survival.

About GI-4000

GI-4000 is a series of Tarmogens that are 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 United States, including significant proportions of pancreas, NSCLC, colorectal, ovarian and other cancers. In a Phase 1 study of advanced pancreas and colorectal cancer patients, GI-4000 was well-tolerated across the full range of doses tested. Immune responses to GI-4000 were observed in the majority of these patients despite the advanced stage of cancer studied in this trial. A multi-center, randomized, placebo-controlled Phase 2 trial of GI-4000 in combination with gemcitabine in resected pancreas cancer patients is ongoing.

About GlobeImmune, Inc.

GlobeImmune is a private Colorado-based company developing active immunotherapies called Tarmogens for the treatment of cancer and infectious diseases. The Company's lead oncology program, GI-4000, is designed to be a treatment for cancers of the lung and gastrointestinal tract. A randomized, placebo-controlled Phase 2 trial in patients with resectable pancreas cancer in combination with adjuvant gemcitabine is ongoing. The Company's lead infectious disease candidate, GI-5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection. GI-5005 is designed to complement both the current and emerging standard of care for hepatitis C infection through the direct elimination of chronically infected cells. A randomized Phase 2 study of GI-5005 in combination with standard of care for patients with chronic hepatitis C infection is currently ongoing.

For additional information, please visit the company's website at www.globeimmune.com.

This press release contains forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and potential advantages of the Company's technology and product candidates. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in this release.