BIOLEX INITIATES STUDY OF TREATMENT FOR HEPATITIS C

Biolex Therapeutics has begun a Phase IIa clinical trial of its lead product candidate, Locteron, a controlled-release interferon alfa. Locteron is being developed as a treatment for chronic hepatitis C. The study is designed to evaluate Locteron in combination with the antiviral drug ribavirin in previously untreated chronic hepatitis C patients. Clinical investigators in this study have commenced patient dosing and top-line results are expected in the middle of 2007.

Locteron combines BLX-883, a recombinant interferon alfa produced with Biolex's proprietary LEX System, with PolyActive, an advanced controlled-release drug delivery technology developed by the company's co-development partner OctoPlus. The pharmacokinetic and pharmacodynamic results demonstrated in the Phase I study of Locteron support dosing of hepatitis C patients once every two weeks, a substantial improvement over currently marketed pegylated interferons that require dosing every week, according to the company.

In addition, Locteron is designed to reduce the severity and duration of certain side effects, such as flu-like symptoms, by eliminating the undesirable early high peak plasma levels that are typically observed with currently marketed pegylated interferons and newer interferon product candidates under development.

The study, known as SELECT-1, will evaluate a range of up to four doses of Locteron given every two weeks in combination with ribavirin in treatment-naive hepatitis C patients with the geneotype-1 variant of the virus. The 32 patients in SELECT-1 will be treated for 12 weeks with the Locteron/ribavirin combination, and the repeat-dose study will assess viral response, safety and tolerability. Results from the study will be used to select the doses of Locteron to be advanced to later-stage clinical development.