Locteron®
The World Health Organization estimates that as many as 170 million people worldwide are chronically infected with hepatitis C and that an additional three to four million people are infected each year. Worldwide sales of interferon for the treatment of hepatitis C were approximately $2.8 billion in 2005, and it is estimated that such sales will increase to more than $5 billion by 2014. Under the current standard of care, interferon alfa is injected weekly for up to 48 weeks and is associated with significant side effects, including fatigue, flu-like symptoms and depression, resulting in high rates of patient non-compliance and discontinuation of therapy. Future treatment is expected to continue to consist of interferon in combination with one or more antiviral agents, which could heighten patient tolerability concerns, because the antiviral agents currently under development have been reported to cause additional side effects.

Locteron is designed to improve patient care by providing a more favorable side-effect profile and more convenient dosing.

Locteron incorporates PolyActive, a controlled-release technology, which provides a gradual release of interferon alfa to patients without the high initial blood levels associated with the significant side effects experienced by patients today.

Locteron is also formulated to allow dosing once every two weeks, a substantial improvement in patient convenience compared to currently marketed interferon alfa products that require dosing every week.

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 controlledrelease mechanism, the currently approved products, Pegasys® and PEG-Intron, and the investigational product Albuferon®, are immediate-release products that lack a controlledrelease
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 SystemSM 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.

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