Medical DevicesBiolex Therapeutics Announces Completion Of Enrollment In SELECT-2 Phase 2b Trial Of Locteron(R) In Chronic Hepatitis C
Biolex Therapeutics, Inc. announced 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-naç¯ve, 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.
Biolex Therapeutics