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Biolex Therapeutics commences phase 2B trial of Locteron in chronic Hepatitis C

Posted Tuesday, April 21, 2009

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Pittsboro, NC - On Monday, Biolex Therapeutics, Inc. announced the commencement of patient dosing 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 associated with pegylated interferons, the current standard of care, including flu-like symptoms. The Company also announced that the preliminary results of the recently completed United States Phase 2a Locteron trial ("PLUS" trial) will be presented at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) April 24, 2009 in Copenhagen, Denmark.

The Phase 2b trial is being conducted in the United States and Europe in 100 treatment-naïve, genotype-1, chronic hepatitis C patients. Patients will be 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® (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.

"The primary objective of the SELECT-2 Phase 2b trial is to identify one or more doses of Locteron for advancement to Phase 3 trials based on an evaluation of viral response and safety and tolerability, including reductions in flu-like symptoms," said Mr. Jan Turek, Biolex's President and Chief Executive Officer. "We believe Locteron to be a valuable asset as it is the only controlled-release interferon alpha under development, and interferon alpha serves as the current standard of care for hepatitis C and provides the backbone for each of the new anti-viral candidates under development. Market research confirms that there is a substantial commercial opportunity for Locteron if a tolerability advantage is demonstrated in more advanced clinical testing."

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 combines BLX-883, a recombinant interferon alpha produced by Biolex in its patented LEX System(SM), with PolyActive®, an advanced controlled-release drug delivery technology developed by OctoPlus N.V. of Leiden, the Netherlands. Locteron is configured to allow 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. The Company has completed three clinical trials of Locteron, and the results of the SELECT-1 Phase 2a trial were presented at the 43rd Annual Meeting of the European Association for the Study of the Liver in April 2008.

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, an anti-CD20 antibody it is optimizing for the treatment of non-Hodgkin's B-cell lymphoma and other diseases.

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Biolex Therapeutics commences phase 2B trial of Locteron in chronic Hepatitis C
Hepatitis C is a contagious liver disease that results from infection with the hepatitis C virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness.

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