Controlled Release Drug for Hepatitis C Being Tested
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Market Wire – Jan. 30, 2007
LEIDEN, NETHERLANDS, January 30 / MARKET WIRE/ — OctoPlus N.V. (Euronext: OCTO), the drug delivery and development company, announces today the commencement of a Phase IIa study with LocteronTM, its controlled release formulation of alfa interferon for treatment of chronic hepatitis C. The Phase IIa study is designed to evaluate Locteron in combination with the anti-viral drug ribavirin in previously untreated chronic hepatitis C patients. Recruitment of patients is ongoing and dosing has started.
Locteron is designed to be a best-in-class therapeutic for patients with chronic hepatitis C, with the potential to induce less side effects, improve patient compliance and provide a more convenient once every two week dosing schedule compared with current therapies. Results from the Phase I study, which was completed in April last year, showed that Locteron is both safe and successful in producing a gradual release over two weeks of alfa interferon after a single injection.
Locteron combines OctoPlus’ proprietary PolyActive(TM) drug delivery technology with BLX-883, a recombinant alfa interferon produced by OctoPlus’ co-development partner Biolex Therapeutics in its patented LEX SystemSM. Locteron is produced in OctoPlus’ cGMP manufacturing facilities in Leiden, the Netherlands.
Design of the Phase IIa study
The Phase IIa study, known as SELECT-1 (Safety and Efficacy of Locteron: European Clinical Trial 1) is a European multi-center, randomized, open- label trial. SELECT-1 will evaluate a range of up to four doses of Locteron administered every two weeks in combination with ribavirin. A total of 32 treatment-naive hepatitis C genotype I patients will receive this treatment during the 12 week study.
The study will assess viral response, safety and tolerability of Locteron. Results from this study are expected mid-2007 and will be used to select the optimal dose range to be tested in a subsequent Phase IIb study.
“The start of our lead product in its Phase IIa study is a major milestone for OctoPlus,” says Joost Holthuis, CEO of OctoPlus. “We believe that Locteron has the potential to be the future treatment of choice for chronic hepatitis C, with less frequent administration and fewer side effects compared to currrent therapies.”
