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HepC Newsletter
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Dema-@aol.com
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Jun 29, 2009 13:30 PDT
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NATAP http://natap.org/
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Time-Released Interferon Locteron Study Enrollment Completed
_EASL: Randomized Trial Comparing Systemic and Local Reactions to
Controlled-release Interferon Alpha2b and Pegylated-interferon Alpha2b in Hepatitis
C Patients Who Failed Prior Treatment _
(http://www.natap.org/2009/EASL/EASL_68.htm) - (05/07/09)
_Co Press Release: Biolex presents Locteron US Phase 2a hepatitis C data
at EASL _ (http://www.natap.org/2009/EASL/EASL_71.htm) - (05/07/09)
EASL: _Peg-Interferon lambda + Ribavirin 4 Weeks _
(http://www.natap.org/2009/EASL/EASL_14.htm) - (04/28/09)
Biolex Therapeutics Announces Completion of Enrollment in SELECT-2 Phase
2b Trial of Locteron(R) in Chronic Hepatitis C
PITTSBORO, NC -- 06/29/09 -- Biolex Therapeutics, Inc. announced today
that it has completed patient enrollment in the SELECT-2 Phase 2b trial of its
lead product candidate Locteron® for the treatment of chronic hepatitis C.
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 side effects, including flu-like symptoms,
associated with pegylated interferons, the current standard of care.
The Phase 2b trial is being conducted in the United States and Europe in
over 100 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 interim results after 12 weeks of treatment
are expected to be used as the basis for the selection of the Locteron
dose(s) for Phase 3 trials.
"We are pleased with the response to the SELECT-2 Phase 2b trial and the
fact that we were able to rapidly complete enrollment using substantially
less clinical sites than we originally anticipated," said Mr. Jan Turek,
Biolex's President and Chief Executive Officer. "Locteron is the only
controlled-release interferon alpha under development and research to date suggests
that this attribute may reduce side effects and has the potential to improve
patient compliance and to reduce discontinuation rates. Extensive market
research recently completed confirms that there is a substantial commercial
opportunity for Locteron if a tolerability advantage is demonstrated in
more advanced clinical testing. We look forward to receiving key results from
SELECT-2 during the fourth quarter of this year."
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 side effects,
including flu-like symptoms, commonly experienced by patients treated with
pegylated interferons and with Albuferon.
About Biolex Therapeutics
Biolex is a clinical-stage biopharmaceutical company that uses its patented
LEX System(SM) to develop 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 which it is advancing toward clinical trials: BLX-155, a
direct-acting thrombolytic designed to dissolve blood clots in patients;
and BLX-301, a humanized anti-CD20 antibody it is optimizing for the
treatment of non-Hodgkin's B-cell lymphoma and other diseases.
Contacts:
Media:
Michelle Linn
Linnden Communications
508-362-3087
_Email Contact_
(http://www2.marketwire.com/mw/emailprcntct?id=65997940E49F8E62)
Investors:
Dale Sander
Chief Financial Officer
858-663-6993
_Email Contact_
(http://www2.marketwire.com/mw/emailprcntct?id=EC9F875BE89F0FC9)
**************************
Incidence Rates and Risk Factors Associated with Hepatocellular Carcinoma
(HCC) in Patients with Advanced Liver Disease Due to Hepatitis C: Results of
the HALTC Trial; Is the HALT-C Study Design Flawed???
_http://www.natap.org/2008/EASL/EASL_51.htm_
(http://www.natap.org/2008/EASL/EASL_51.htm)
Retreating chronic hepatitis C with daily interferon alfacon-1/ribavirin
after nonresponse to pegylated interferon/ribavirin: DIRECT results
_http://www.natap.org/2009/HCV/060209_03.htm_
(http://www.natap.org/2009/HCV/060209_03.htm)
Maintenance Therapy Did Not Reduce Incidence of HCC in the HALT-C Study
_http://www.natap.org/2009/HIV/062109_02.htm_
(http://www.natap.org/2009/HIV/062109_02.htm)
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