The product, named Locteron, combines OctoPlus’ proprietary biodegradable PolyActive drug delivery technology with Biolex’ BLX-883, a recombinant alfa interferon produced in its proprietary LEX System.
Locteron is designed to be more convenient for patients than the current pegylated alfa interferon products on the market as it is expected to be administered every two weeks.
Under the terms of the agreement, OctoPlus and Biolex will co-develop Locteron, including the establishment of manufacturing capabilities to support clinical development and commercialization. Initial focus will be on the treatment of Hepatitis C and the companies expect Locteron to enter clinical trials in mid-2005.
In preclinical studies, BLX-883 has proved to be comparable to commercially available alfa interferon and can be produced cost-effectively using Biolex’ proprietary LEX System.
Biolex recently announced the filing of an investigational new drug application (IND) with the FDA and the European equivalent, a clinical trial application (CTA), for the initiation of clinical trials of BLX-883. Dosing in the initial clinical study has commenced.
OctoPlus has shown in preclinical studies that, when formulated with PolyActive, sustained alfa interferon levels in plasma can be achieved, for a period up to two weeks and longer, with a single injection. In contrast, all pegylated alfa interferon products currently on the market require weekly injections.
OctoPlus has also demonstrated in these preclinical studies that alfa interferon, when formulated with PolyActive, is gradually released after injection, thus avoiding both high peak and low trough plasma levels. This key feature may result in an improved clinical profile for the drug candidate with possibly fewer side-effects.
“This collaboration builds on our business strategy to develop a pipeline of proprietary Biolex proteins,” said Jan Turek, president and CEO of Biolex. “We are delighted to be working with OctoPlus to develop this product, and look forward to having Locteron, our second drug candidate, enter the clinic later this year.”