GlobeImmune's Hepatitis C Therapeutic Vaccine, GI-5005, Improves EVR Rates To 94

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GlobeImmune's Hepatitis C Therapeutic Vaccine, GI-5005, Improves EVR Rates To 94

Percent In Phase 2 Clinical Trial

Article Date: 26 Apr 2009 - 1:00 PDT

http://www.medicalnewstoday.com/articles/147530.php

Twelve-week Phase 2 clinical trial data show that patients treated with GI-5005,

GlobeImmune's targeted molecular immunogen (Tarmogen®) for the treatment of

hepatitis C virus infection, had 94 percent early virologic response (EVR) rate

in treatment naïve patients. The study compared GI-5005 plus standard of care

(SOC) -- pegylated interferon and ribavirin -- versus SOC alone in patients with

chronic genotype 1 hepatitis C infection.

The study data will be presented in a poster presentation tomorrow by

Lawitz, M.D., of Alamo Medical Research Center, San , Tex. at the 44th

Annual Meeting of the European Association for the Study of the Liver (EASL) in

Copenhagen, Denmark. The 94 percent EVR rate in naïve subgroups including those

with high baseline viral loads, is defined as a greater than 100-fold reduction

of HCV RNA from baseline at 12 weeks and is an eight to twelve percent

improvement over the SOC alone arm.

" We were pleased to see a 94 percent EVR rate in the treatment naïve patient

population, " said Dr. Lawitz, the study's lead author. " We believe that this

increase in EVR over standard of care alone may indicate that the GI-5005

mechanism of action is complementary to the current standard care. "

Additional exploratory analyses of serum fibrosis (Fibrotest) and necrosis

(Actitest) markers showed a two-fold improvement in the proportion of patients

with improved serum Fibrotest, and a fifty percent reduction in the number of

patients with worsening Fibrotest scores after 24 weeks in the group receiving

the triple therapy. At the 24 week time point, the triple therapy improved serum

Actitest scores by up to 14 percent in treatment naïve patients when compared to

SOC alone. The treatment naïve group with high viral load receiving the triple

therapy also saw a 14 percent advantage over the SOC group in normalization of

alanine transaminase (ALT), a marker of liver damage.

" We believe that the improvement in ALT, Actitest and Fibrotest scores seen in

patients in the triple therapy arm of the study suggests that triple therapy

with GI-5005 may lead to improvements in liver inflammation, necrosis and

fibrosis compared to standard of care alone, " said Apelian, M.D., Ph.D.,

GlobeImmune's Chief Medical Officer. " At this interim stage of our Phase 2

program, we are encouraged by the data as we believe they suggest that triple

therapy including GI-5005 may improve sustained virologic response as well as

liver histology, both of which will be measured in the current study and could

serve as primary or co-primary efficacy endpoints in a future Phase 3 HCV

program. "

The GI-5005-02 clinical trial is a randomized, multi-center, Phase 2 study

evaluating 140 patients, all with genotype 1 HCV infection. In the trial, 74

percent of patients had never received prior treatment, and the remaining 26

percent had failed prior treatment.

About GlobeImmune

GlobeImmune Inc. is a private company developing targeted molecular immunogens,

Tarmogens, for the treatment of cancer and infectious diseases. The company's

lead product candidate, GI-5005, is a Tarmogen for the treatment of chronic

hepatitis C infection (HCV). GI-5005 is designed to complement both the current

standard of care and emerging novel therapies for HCV. The company's lead

oncology program, GI-4000, targets cancers caused by mutated versions of the Ras

oncoprotein. GI-4000 is being investigated in clinical trials for the treatment

of pancreas cancer as well as other cancers that contain mutated Ras, including

non-small cell lung cancer and colorectal cancer.

For additional information, please visit the company's Web site at

http://www.globeimmune.com.

This news release and the anticipated presentation contain forward-looking

statements that involve risks and uncertainties, including statements relating

to initiation and progress of the Company's clinical trial programs and the

preliminary results from the clinical trials. 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 the release and

anticipated presentation.