›Locteron Dosed Once Every Two Weeks Demonstrated a Comparable Reduction in Viral Load Compared to Once-Weekly Standard of Care With 57% Less Flu-Like Adverse Events
Friday April 16, 2010, 1:01 am EDT
PITTSBORO, NC--(Marketwire - 04/16/10) - Biolex Therapeutics, Inc. announced that interim results from EMPOWER, a prospectively designed analysis of results from two Phase 2b trials of Locteron®, were presented yesterday in a late-breaker session at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the flu-like symptoms associated with pegylated interferons, the current standard of care. In the EMPOWER study, the 480 ug dose of Locteron demonstrated viral kinetics and response rates that were comparable to the PEG-Intron® control while also achieving a 57% reduction in flu-like adverse events.
The objective of the EMPOWER study was to test the hypothesis that the 480 ug dose of Locteron dosed once every two weeks reduces flu-like symptoms but retains equivalent efficacy compared to PEG-Intron (1.5 ug/kg, administered every week). The 133 patients in the EMPOWER study were enrolled in two contributing Phase 2b trials:
• SELECT-2, a Phase 2b dose-finding trial evaluating the 320, 480 or 640 ug doses of Locteron versus PEG-Intron. Interim results from SELECT-2 were also presented at EASL yesterday. SELECT-2 contributed a total of 59 Locteron 480 ug and PEG-Intron patients to EMPOWER.
• The 480 STUDY, a Phase 2b trial evaluating the 480 ug dose of Locteron versus PEG-Intron. Interim results from the 480 STUDY will be presented in an oral presentation at EASL later today. The 480 STUDY contributed 74 patients to EMPOWER.
All patients were treatment-naive-genotype-1 subjects with chronic hepatitis C, and all patients were also treated with weight-based ribavirin. A total of 30 sites participated in the two trials (14 sites in the US, 11 in Europe, and five in Israel). All patients in EMPOWER have completed at least six weeks of study, and over 80% of the patients have completed 12 weeks of study.
Through six weeks of treatment, Locteron 480 ug administered once every two weeks demonstrated reductions in viral loads (mean changes in HCV RNA from baseline) that were somewhat more rapid than that achieved with PEG-Intron administered once per week. Rates of undetectable HCV RNA achieved after six weeks of treatment were 31% for Locteron 480 ug and 19% for PEG-Intron. The currently available results after 12 weeks of treatment (a number of patients have not yet reached the 12-week time point) suggest comparable reductions in mean HCV RNA and rates of undetectable HCV RNA for Locteron 480 ug and PEG-Intron.
In EMPOWER, flu-like adverse events were predefined to include arthralgia, chills, fever, headache, and myalgia. A substantial reduction in flu-like adverse events for patients treated with Locteron was evident even in the first week of the trial and continued through the 12-week time point available for evaluation. After six weeks of treatment, total flu-like adverse events reported for Locteron 480 ug were 52% less than the total events reported for PEG-Intron. Available results after 12 weeks of treatment suggest total flu-like adverse events reported for Locteron 480 ug were 57% less than the total reported for PEG-Intron.
The EMPOWER results were presented by the lead author, Walker Long, MD, Chief Medical Officer and Vice President, Drug Development, Biolex Therapeutics, in the form of a poster titled "Q2Week Controlled-Release Interferon Alpha2b + Ribavirin Reduces Flu-like Symptoms >50% and Provides Equivalent Efficacy in Comparison to Weekly Pegylated Interferon Alpha2b + Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C: Results from EMPOWER, a Randomized Open-Label 12-week Comparison in 133 Patients."
"The EMPOWER study allows us to focus on the activity associated with one specific dose of Locteron and test our hypothesis that equivalent efficacy can be achieved while greatly reducing flu-like adverse events," said Dr. Long. "These results exceed our expectations. We believe that the importance of reducing flu-like adverse events will grow with the advent of direct-acting virals and the shortening of therapy, due to the prevalence of these side effects during the first three months of treatment."
Three serious adverse events were reported for Locteron 480 ug and three were reported for PEG-Intron. All events were expected labeled events for interferon alpha. Higher rates of mild or moderate (Grade 2 and Grade 3) reductions in measurements of white blood cell counts, platelets and neutrophils were observed for Locteron 480 ug compared to PEG-Intron, while higher rates of mild or moderate reductions in measurements of hemoglobin were observed for PEG-Intron. There were no Grade 4 reductions in hematological measurements for either Locteron 480 ug or for PEG-Intron. There were no novel toxicities identified in either cohort of the trial.
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.‹
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