GI-5005 Improves Virologic Clearance of HCV in Combination with PegIFN/Ribavirin in IL28B T/T Patients
Clinical Trial Data to be Presented at The Liver Meeting® 2012 in Boston
BOSTON, Nov. 11, 2012 - GlobeImmune, Inc., today announced Phase 2b clinical data showing that GI-5005, a Tarmogen® product candidate for the treatment of chronic hepatitis C virus (HCV) infection, improved virologic clearance of HCV in combination with pegylated-interferon plus ribavirin (P/R) in genotype 1, IL28B T/T patients. IL28B T/T is an unfavorable patient genotype that predicts poor sustained virologic response (SVR24) to P/R.
GI-5005-02 is a randomized Phase 2b clinical trial evaluating GI-5005 plus P/R compared to P/R alone in subjects with chronic genotype 1 HCV infection. Preliminary data from the trial showed that the largest improvement in SVR24 was observed in subjects with the most difficult-to-treat IL28B T/T genotype. GI-5005 enhanced HCV-specific cellular immunity and improved SVR24 [GI-5005+P/R: 3/5 (60%) compared to P/R alone: 0/5 (0%)].
Following this result, the trial was expanded to enroll and treat an additional 17 genotype 1, treatment-naïve subjects having the IL28B T/T genotype. In the study, presented by Dr. M. L. Shiffman, the Liver Institute of Virginia, Bon Secours Virginia Health System, Newport News, VA, GI-5005 in combination with P/R was well tolerated and had a higher end of treatment virologic response rate [GI-5005+P/R; 10/16 (63%) compared to P/R alone; 3/11 (27%)].
"GI-5005 in combination with pegylated interferon + ribavirin appears to have an effect in the most difficult-to-treat IL28B patients," said Dr. Shiffman. "GI-5005 could potentially be used in treatment refractory HCV patient subgroups in future regimens."
GI-5005 contains a fusion of two hepatitis C proteins, NS3 and Core, which are highly conserved across HCV genotypes and are recognized by T cells. GI-5005 is engineered to activate an HCV-specific T cell immune response, resulting in the reduction of cells containing viral antigens.
The World Health Organization estimates that up to 170 million people globally are infected with HCV, with three to four million new infections each year. Approximately 20% to 30% of all HCV patients will face life-threatening complications as a result of their disease. In industrialized countries, HCV accounts for 40% of cases of end-stage cirrhosis, 60% of cases of hepatocellular carcinoma and 30% of liver transplants.
GlobeImmune is a biopharmaceutical company focused on developing therapeutic products for 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, which stimulate predominately 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.
# # #
David Apelian, M.D., Ph.D.
SVP Research & Development and Chief Medical Officer
GLOBEIMMUNE MEDIA CONTACTS:
Lena Evans or Tony Russo, Ph.D.
Russo Partners LLC
T: 212-845-4262 or 212-845-4251
Posted: November 2012