This does sound good, I agree.Thanks for posting this.
This is so very encouraging. Great post!
Locteron side effect and patient tolerability results in SELECT-1 were as follows:
Locteron was well tolerated at all doses. There were no serious adverse events in the 160 µg, 320 µg, and 480 µg cohorts. There was one serious adverse event in the 640 µg cohort, a case of otitis, or inflammation of the ear, which completely resolved. The vast majority (over 90%) of the adverse events that were experienced were rated as mild.
The majority of the side effects experienced by patients treated with Locteron in the SELECT-1 study appear to be less frequent and less severe than the side effects reported in previous clinical trials for pegylated interferons and Albuferon. For example, only one patient (3%) in the SELECT-1 study receiving Locteron experienced an adverse event rated as severe, indicating an improvement over previously reported incidences of 14% and 18% in clinical trials for Pegasys® and Albuferon, respectively. In addition, serious adverse events in SELECT-1 were limited to the one aforementioned event occurring in the highest, 640 µg, Locteron dose cohort.
"Our original hypothesis for Locteron was that combining a controlled-release mechanism with a proven interferon alfa would have the potential to provide a high level of efficacy while resulting in an improvement in side effects and patient tolerability," said David Spencer, Ph.D., Biolex Chief Operating Officer and Senior Vice President, Research and Development. "SELECT-1 has highlighted three doses that appear to provide a favorable combination of efficacy and improved tolerability. We believe that the need for improved patient tolerability will become even greater with the emergence of new antiviral products. These emerging antiviral products are associated with additional side effects, further adding to the potential for Locteron to be the interferon of choice for future combination therapy as a result of its potential for improved patient tolerability."
Additional results to be presented at the AASLD conference include full viral kinetic and pharmacokinetic results
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Locteron Overview
Locteron combines BLX-883, a recombinant interferon alfa produced by Biolex in its patented LEX System(SM), with PolyActive(TM), an advanced controlled-release drug delivery technology developed by OctoPlus. Locteron is the only controlled-release interferon alfa known to us to be currently in active Phase 2 clinical development for the treatment of hepatitis C and is designed to improve patient care through a more favorable side-effect profile and more convenient patient dosing. Locteron is configured to allow dosing once every two weeks, an improvement in patient convenience compared to currently marketed pegylated interferon alfa products that require dosing every week. More importantly, Locteron's controlled-release mechanism results in the gradual release of interferon alfa to patients over the duration of two weeks. This controlled-release mechanism is designed to cover inter-dose troughs while reducing the frequency, duration and severity of side effects, including flu-like symptoms, commonly experienced by patients treated with currently marketed pegylated interferons and with Albuferon.
Biolex and OctoPlus plan to commence SELECT-2, a Phase 2b trial of Locteron in the first half of 2008. The 12-week results of the Phase 2b trial will be used as the basis for dose selection for the commencement of the Phase 3 development program. 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
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(TM), under joint development with OctoPlus N.V., is in Phase 2 clinical trials and is the only controlled-release interferon alfa known to be currently in active clinical development for the treatment of chronic hepatitis C.