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[DewDiligence]

Biolex Presents Phase-2b Locteron Data from ‘480’ Study

[Note: the EMPOWER phase-2b study reported at EASL (#msg-49095353) is a meta-analysis consisting of data from the ‘480’ study (in this PR) and the SELECT-2 study (#msg-49095156).]

http://finance.yahoo.com/news/Biolex-Announces-Presentation-iw-100363041.html?x=0&.v=1

›Monday April 19, 2010, 12:01 am EDT

PITTSBORO, NC--(Marketwire - 04/19/10) - Biolex Therapeutics, Inc. announced that interim results from a Phase 2b trial of Locteron®, the "480 STUDY," were presented Friday evening 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. Through six and 12 weeks of treatment in the trial, Locteron achieved the Company's objective by demonstrating viral kinetics and response rates that were at least comparable to the PEG-Intron® control while also achieving a reduction in flu-like adverse events.

The Phase 2b trial is being conducted in Europe and Israel and includes 74 treatment-naïve hepatitis C patients with the genotype-1 variant of the virus. The 480 STUDY is designed to provide, in combination with the SELECT-2 Phase 2b trial, patient results for use in the EMPOWER analyses of efficacy and tolerability of the 480 ug dose of Locteron versus PEG-Intron. Interim results from SELECT-2 and EMPOWER were also presented at the EASL conference last week [see #msg-49095156 and #msg-49095353, respectively].

The 480 STUDY includes the first clinical evaluation of the single-injection drug configuration of Locteron planned for use in Phase 3 trials.

In Panel A of the 480 STUDY, 42 patients were randomized in Europe to receive treatment with either the 480 ug dose of Locteron (in the same two-injection configuration as the SELECT-2 trial) or PEG-Intron. In Panel B, 32 patients in Israel were randomized to receive treatment with either the 480 ug dose of Locteron (single-injection format) or PEG-Intron. Participants in the 480 STUDY are treatment-naive, genotype-1, chronic hepatitis C patients, and all participants also received weight-based ribavirin. All patients in Panel A of the trial have completed 12 weeks of study and all patients in Panel B have completed at least six weeks of study.

In both Panel A and Panel B, the Locteron 480 ug dose administered once every two weeks demonstrated reductions in viral loads (mean changes in HCV RNA from baseline) that were at least comparable to that achieved with PEG-Intron administered once per week. Rates of undetectable HCV RNA achieved in each Panel and on a combined basis are outlined in the table below:

 
                          480 STUDY Interim Results 
                   % of Patients with Undetectable HCV RNA 
  
                   Panel A               Panel B              Combined 
            --------------------  --------------------  -------------------- 
            Locteron              Locteron              Locteron 
             480 ug   PEG-Intron   480 ug   PEG-Intron   480 ug   PEG-Intron 
            --------  ----------  --------  ----------  --------  ---------- 
             (n=19)     (n=23)     (n=16)     (n=16)     (n=35)     (n=39) 
 6 Weeks       42%        22%        38%        6%         40%        15% 
 12 Weeks      63%        61%         *          *          *          * 
  
 *Majority of patients in Panel B have not yet completed 12 weeks of study.

In the 480 STUDY, flu-like adverse events were predefined to include arthralgia, chills, fever, headache, and myalgia. After six weeks of treatment, total flu-like adverse events reported for Locteron 480 ug for Panel A and Panel B combined 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 58% less than the total reported for PEG-Intron. The majority of the difference occurred in Panel A as the flu-like adverse events reported in Panel B, which is still in process, were low in both cohorts.
The 480 STUDY results were presented by the lead author, Zahariy Krastev, MD, Principal Investigator, University Hospital "St Ivan Rilski," Sofia, Bulgaria, in an oral presentation titled "Randomized, Open-Label, 12-Week Comparison of Controlled-Release Interferon Alpha2b + Ribavirin Vs. Pegylated-Interferon Alpha2b + Ribavirin in Treatment-Naive Genotype1 Hepatitis C: 4 Week Results from 480 STUDY (Panel A)."

"We are pleased that the efficacy of Locteron in these interim results is at least comparable to PEG-Intron despite the fact that Locteron was dosed half as frequently," said Dr. Krastev. "There is a need for a more convenient and more tolerable interferon component of hepatitis C therapy, particularly with the advent of triple-combination therapy, and I look forward to participating in expanded trials of Locteron in the future."

One serious adverse event has been reported to date for Locteron 480 ug and three were reported for PEG-Intron. All events were expected labeled events for interferon alpha. No Grade 4 reductions in hematological measurements have been reported to date for either Locteron 480 ug or for PEG-Intron. There were no novel toxicities identified in either cohort of the trial.‹