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43rd Annual Meeting of the European Association For The Study Of The Liver
Milan, Italy
April 23-27, 2008
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Biolex Therapeutics Researchers Present Locteron (controlled-release interferon alpha) Phase 2a Hepatitis C Trial Results at EASL Conference
  PITTSBORO, NC -- 04/24/08 -- Biolex Therapeutics, Inc. announced that the results from its SELECT-1 Phase 2a clinical trial of LocteronĘ will be presented today at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL). As a controlled-release interferon alfa, Locteron is designed to improve patient care through a more favorable side-effect profile compared to existing pegylated interferon products and Albuferon, each of which lacks a controlled-release mechanism.
SELECT-1 was a twelve-week trial in 32 treatment-naive patients chronically infected with the genotype-1 variant of the hepatitis C virus. The Phase 2a trial was designed to evaluate four doses of Locteron administered once every two weeks in combination with the antiviral drug ribavirin. In the SELECT-1 trial, Locteron demonstrated a strong anti-viral response with 100% of the patients in the two highest dose groups achieving early virologic response. Viral kinetic modeling of the SELECT-1 results by Eva Herrmann, Ph.D. of Saarland University, Homburg/Saar, Germany and Stefan Zeuzem, M.D. of JW Goethe-University Hospital, Frankfurt/Main, Germany, demonstrated a statistically significant dose response. Updated results presented at the EASL meeting also included the effect of Locteron on biomarkers and alanine aminotransferase (ALT), each of which showed a dose-dependent response to Locteron.
SELECT-1 Results Presented Today at EASL Conference
The SELECT-1 results will be presented today at the EASL conference in a poster titled "Viral Kinetics during Treatment with a Controlled-Release Recombinant Interferon Alfa-2b in Genotype 1 Chronic Hepatitis C Patients." Anti-viral results for the SELECT-1 trial were as follows:
· The percentage of patients who achieved early virologic response (EVR), defined as at least a two-log reduction in hepatitis C virus, was 100% in the 640 and 480 μg dose cohorts and 88% in the 320 μg dose cohort, compared to 37.5% in the 160 μg dose cohort.
· A clear dose response was observed in the study, and viral kinetic modeling by Drs. Herrmann and Zeuzem demonstrated statistically significant HCV RNA reduction during the entire 12-week treatment period.
· Average viral reduction after 12 weeks of treatment ranged from 4.7 to 4.2 logs for the 640, 480 and 320 μg doses, compared to 1.8 logs for the lowest dose of 160 μg.
· Locteron was generally well tolerated at all doses. There were no serious adverse events in the 160 μg, 320 μg, and 480 μg cohorts. There was one serious adverse event in the 640 μg cohort, a case of otitis, or inflammation of the ear, which resolved.
· Over 90% of the adverse events that were experienced were rated as mild.
The SELECT-1 trial also measured certain biomarkers, the results of which were as follows:
· Locteron resulted in a dose-dependent reduction in alanine aminotransferase (ALT), an enzyme released by the liver into the blood when the liver is damaged.
· Locteron resulted in a dose-dependent increase in oligoadenylate synthetase (OAS) and neopterin, markers commonly associated with the biological effects of interferon alfa.
Locteron Overview
As a controlled-release interferon alfa, Locteron is designed to improve patient care through a more favorable side-effect profile compared to existing pegylated interferon products and Albuferon (albumin-fused interferon), each of which lack a controlled-release mechanism. Locteron combines BLX-883, a recombinant interferon alfa produced by Biolex in its patented LEX System(SM), with PolyActive(TM), an advanced controlled-release drug delivery technology developed by OctoPlus. Locteron is configured to allow dosing once every two weeks, an improvement in patient convenience compared to currently marketed pegylated interferon alfa products that require dosing every week. More importantly, Locteron's controlled-release mechanism results in the gradual release of interferon alfa to patients over the duration of two weeks. This controlled-release mechanism is designed to cover inter-dose troughs which may contribute to the frequency, duration and severity of side effects, including flu-like symptoms, commonly experienced by patients treated with currently marketed pegylated interferons and with Albuferon. Biolex is co-developing Locteron with its partner OctoPlus N.V.
In February 2008, Biolex announced the commencement of patient dosing in a U.S. Phase 2a clinical trial of Locteron in hepatitis C. The U.S. "PLUS" Phase 2a trial is designed to expand upon the favorable results from the SELECT-1 trial reported above and to provide U.S. investigators first-hand experience with Locteron.
Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.