PITTSBORO, NC -- 02/10/10 --
Biolex Therapeutics, Inc. announced today
that interim results from two Phase 2b clinical trials of its lead product
candidate Locteron® for the treatment of chronic hepatitis C have been
accepted for oral and poster presentations at the 45th Annual Meeting of the
European Association for the Study of the Liver (EASL) to be held in
Vienna, Austria in April 2010. 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. The objectives of the two Phase 2b trials are to demonstrate viral
kinetics and response that is at least equivalent to the PEG-Intron®
control while also achieving at least a 50% reduction in flu-like adverse
events.
The interim results to be presented at EASL are from two ongoing Phase 2b
clinical trials, the "SELECT-2" dose-finding trial evaluating the 320, 480
and 640 µg doses of Locteron, and the "480 STUDY" which is further
evaluating the 480 µg dose. Researchers will present the 12-week interim
results from these two trials at the EASL conference. The Company does not
expect to release the results in advance of the presentations in accordance
with the embargo requirements of EASL.
"We are pleased that the interim results from the SELECT-2 and 480 Phase 2b
trials have been selected for presentation at this prestigious conference,"
said Mr. Jan Turek, Biolex's President and Chief Executive Officer. "These
two trials serve to confirm each other, providing us with great confidence
in the robustness of the results that have been attained to date.
Locteron's expected product profile was tested in extensive market research
in the first half of 2009, and the research results suggested that the
potential tolerability and dosing convenience advantages of Locteron
supported a substantial commercial opportunity."
Phase 2b Clinical Trials
The SELECT-2 Phase 2b trial is being conducted in the United States and
Europe in 116 treatment-naïve, genotype-1, chronic hepatitis C patients.
Patients were randomized into one of four dosing cohorts, the 320, 480 or
640 µg dose of Locteron (administered once every two weeks) or a control
arm consisting of PEG-Intron® (1.5 µg/kg, administered every week), with
all patients receiving weight-based ribavirin. Patients will be treated for
48 weeks and will be followed for an additional 24 weeks to determine the
sustained virologic response (SVR) rate.
The 480 STUDY Phase 2b trial is being conducted in Europe and Israel and
will include at least 72 treatment-naïve hepatitis C patients with the
genotype-1 variant of the virus. The trial is designed to provide
additional data to support the expected Locteron tolerability advantage
versus PEG-Intron and to provide clinical experience with the same Locteron
configuration that is planned for use in Phase 3 trials.
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.
Locteron Overview
Locteron is a controlled-release interferon alpha designed to improve
patient care in the treatment of hepatitis C through a more favorable
side-effect profile and dosing convenience compared to existing pegylated
interferon products. In contrast to Locteron's controlled-release
mechanism, the currently approved products, Pegasys® and PEG-Intron, and
the investigational product Albuferon®, are immediate-release products
that lack a controlled-release mechanism. Interferon alpha serves as the
foundation of current combination therapy for hepatitis C patients, and all
major hepatitis C drug candidates currently in clinical trials are being
studied in combination with interferon alpha. It is estimated that
worldwide sales of interferon products for the treatment of hepatitis C
will approach $6 billion by 2016.
Locteron incorporates an advanced controlled-release drug delivery
technology that allows dosing once every two weeks, more convenient than
Pegasys and PEG-Intron, each of which require dosing every week. More
importantly, Locteron's controlled-release mechanism results in the gradual
release of interferon alpha 2b to patients over the duration of two weeks
and avoids the early peak plasma levels of the active interferon that
characterize the pegylated interferons and Albuferon. This
controlled-release mechanism is designed to reduce the frequency, duration
and severity of flu-like symptoms commonly experienced by patients treated
with pegylated interferons and with Albuferon.
About Biolex Therapeutics
Biolex is a biopharmaceutical company that uses its patented LEX System(SM)
to develop follow-on biologics, hard-to-make therapeutic proteins and to
optimize monoclonal antibodies. The LEX System is a novel technology that
genetically transforms the aquatic plant Lemna to enable the production of
biologic product candidates. The company's product candidates are designed
to provide superior efficacy/tolerability profiles and to address large,
proven pharmaceutical markets. Biolex's lead product candidate,
Locteron®, is in Phase 2b clinical testing for the treatment of chronic
hepatitis C. Biolex has also developed two other product candidates that
capitalize on the benefits of the LEX System: BLX-155, a direct-acting
thrombolytic designed to dissolve blood clots in patients; and BLX-301, a
humanized anti-CD20 antibody glyco-optimized for the treatment of
non-Hodgkin's B-cell lymphoma and other diseases.
Contacts:
Media:
Michelle Linn
Linnden Communications
508-362-3087
Email Contact
Investors:
Dale Sander
Chief Financial Officer
858-663-6993
Email Contact
