Louisville, CO, June 7, 2006, GlobeImmune, Inc. today announced the initiation of a randomized, placebo-controlled, multi-center Phase 2 clinical trial of GI-4000, GlobeImmune’s therapeutic vaccine for the treatment of patients with early-stage pancreas cancer. The primary goal of the study is to compare the recurrence-free survival at 15 months in patients treated with either GI-4000 or placebo, in combination with adjuvant gemcitabine after surgery. Pancreas cancer is an aggressive, deadly disease; median overall survival for patients eligible for this trial has been typically 13-20 months. GI-4000 is a TarmogenTM (Targeted Molecular Immunogen), GlobeImmune’s proprietary yeast-based vaccine system that is designed to stimulate “killer” T cells in the immune system to find and destroy diseased cells.
“Despite successful surgery, pancreas cancer remains a lethal disease. Among patients who have had surgery, 50% die from recurrent tumors within 2 years and only 20% are alive at 5 years. These patients are in serious need of effective new treatments,” said Dr. David Apelian, Chief Medical Officer of GlobeImmune. “We are pleased to have initiated a Phase 2 study that explores the potential of Tarmogens in such a critical area.”
GI-4000 Phase 1 Interim Results
GI-4000 is designed to activate the immune system against cancer cells containing a mutated protein called Ras that is found in 80-90% of pancreas tumors. In a recently completed Phase 1 study of end-stage pancreas and colorectal cancer patients, GI-4000 was generally well-tolerated across the full range of doses tested. Immune responses to GI-4000 were observed in many patients despite the advanced stage of cancer studied in this trial.
GI-4000-02 Phase 2 Study Design
GI-4000 is designed to activate the immune system to attack diseased cells containing mutated Ras proteins associated with cancer. GI-4000-02 is a randomized, placebo-controlled, double-blind study that will be run at over 50 centers in the United States. After successful pancreas cancer surgery, patient tumor specimens will undergo DNA sequencing to identify whether the tumor contains a ras mutation contained in GI-4000. Patients will receive three, subcutaneous priming doses of study therapy before the initiation of adjuvant gemcitabine, the current standard of care chemotherapy, as well as boosting doses between rounds of gemcitabine treatment. After completion of chemotherapy, patients will be eligible to continue receiving monthly injections of study therapy. Efficacy endpoints for this trial include recurrence-free survival at 15 months, overall median survival and biochemical disease recurrence.
About Tarmogens
Tarmogens are whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express one or more protein antigens that stimulate the innate immune system, as well as activate disease-specific “killer” T cells that identify and destroy cancer or virally-infected cells. GlobeImmune’s patented Tarmogen platform has a number of potential advantages over other approaches including that Tarmogens generate potent T cell immune responses, are not neutralized by the immune system, can be rapidly engineered and are simple and scalable to manufacture.
About GlobeImmune
GlobeImmune, Inc. is a biopharmaceutical company pioneering the discovery, development and manufacturing of potent, targeted molecular immunotherapy products called Tarmogens for the treatment of cancer and infectious diseases. In addition to its lead product series GI-4000, GlobeImmune has an ongoing Phase 1b trial for its second product, GI-5005, a Tarmogen intended for the treatment of chronic hepatitis C infection. 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. Actual results could differ materially from those projected and the Company cautions investors not to place undue reliance on the forward-looking statements contained in this release.
GLOBEIMMUNE CONTACTS:
Kirk Christoffersen
Senior Director, Corporate Development
GlobeImmune, Inc.
T: 303-625-2700
information@globeimmune.wpengine.com