GlobeImmune Announces Presentation of Results from a Randomized Phase 1b Study of the GI-5005 Tarmogen in Patients with Chronic Hepatitis C Infection
LOUISVILLE, CO - November 6, 2007 - GlobeImmune, Inc. today announced results from the additional higher dose cohorts from the Company's randomized, placebo-controlled Phase 1b clinical trial evaluating the safety, immunogenicity, and initial efficacy of GI-5005 in patients with chronic hepatitis C infection. The data were presented today at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). In the Phase 1b study thus far, GI-5005 has demonstrated:
1. A favorable safety profile with the dose escalation to the highest planned dose without dose limiting toxicity. Safety findings were generally limited to transient local injection site reactions and transient mild constitutional complaints.
2. Strong trends for a dose dependent response in the percent of patients that normalize their ALT (a marker of liver damage) compared with placebo, ranging from no normalizations in the placebo group up to 50% of the patients in the highest dose group (40YU).
3. Viral load reductions (nadir) in six treated patients ranging from -0.75 log10 to -1.4 log10. Viral load reductions were achieved with only 12 weeks of GI-5005 monotherapy with no concurrent anti-viral therapy.
4. Biologic / immune activity by converting patients from an immune response profile associated with chronic infection to one similar to patients who clear the virus naturally during the acute phase as measured by ELISpot assay.
5. No placebo patients had near log10 reductions of viral load or demonstrated an immune response by ELISpot assay.
"These results indicate that a short course of GI-5005 alone is capable of generating an HCV specific immune response that is associated with improved liver inflammation and clearance of infected hepatic cells. We find this particularly encouraging since these patients were not treated with concurrent anti- viral therapy; we expect that an immune-based therapy, such as GI-5005, would complement current standard of care or future anti-virals," said David Apelian, M.D., Ph.D., Chief Medical Officer of GlobeImmune. "A Phase 2 trial comparing GI-5005 plus pegylated interferon plus ribavirin versus pegylated interferon plus ribavirin alone is now being initiated at 50 centers in the United States, EU, and India. Long-term GI-5005 salvage therapy will also be examined in this trial in patients who fail to achieve an early virologic response (EVR) or do not tolerate treatment in the pegylated interferon/ribavirin arm."
GI-5005 is GlobeImmune's lead infectious disease product from its proprietary Tarmogen active immunotherapy platform for the treatment of chronic hepatitis C infection. GI-5005 is whole, heat-killed recombinant yeast genetically modified to express HCV-specific protein targets. The mechanism of action for GI-5005 (i.e. immune elimination of infected hepatic cells) may work synergistically in combination with the current or emerging standard of care, which directly inhibits viral replication, to more effectively eradicate hepatitis C virus from the liver. Additionally, this mechanism of action may offer an option for interferon-intolerant or interferon-contraindicated patients as a long-term monotherapy. A randomized Phase 2 study evaluating GI-5005 plus standard of care (pegylated interferon plus ribavirin) versus standard of care alone is planned to begin in the fourth quarter of 2007.
About Hepatitis C Infection
The World Health Organization (WHO) estimates that 170 million people globally are infected with hepatitis C virus (HCV) with three to four million new infections each year. Roughly 80-90% of these cases fail to resolve acutely and evolve into a chronic state. The population of patients with chronic HCV infections is estimated at approximately four million cases in the United States and five to ten million in Europe. Of the four million patients infected in the United States, only 20-40% are estimated to be currently diagnosed given the largely asymptomatic nature of HCV infection. The current standard of care for genotype 1 HCV patients, the most common subtype in the United States, is 48 weeks of pegylated interferon plus ribavirin. This treatment is often poorly tolerated and only results in cure rates (sustained virologic response) of approximately 50%.
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 product candidate, GI- 5005, is a Tarmogen being developed for the treatment of chronic hepatitis C infection that has completed Phase 1b clinical trials. 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. The Company has initiated a randomized, placebo-controlled Phase 2 study of GI-5005 in combination with standard of care for chronic hepatitis C infection. 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.
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.
Brad Miles BMC Communications Group phone: 212-477-9007 ext 17
Timothy C. Rodell, M.D. President & Chief Executive Officer 1450 Infinite Drive Louisville, CO 80027
Posted: November 2007