BLX-883 is the first clinical-stage therapeutic candidate produced in Biolex’ GMP facilities using its proprietary LEX system. In the phase I study BLX-883 was safely administered at a clinically relevant dose and demonstrated bioactivity consistent with Intron A, a currently marketed alfa interferon used as a comparator.
Alfa interferon is used in the treatment of hepatitis C, hepatitis B, and multiple cancers and its worldwide sales currently exceed $3 billion.
The phase I study was designed to evaluate the safety and pharmacology of BLX-883 in 24 healthy volunteers. The study was conducted under an investigational new drug application (IND) submitted to the FDA and a clinical trial authorisation application (CTA) filed with the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Biolex has reported that no safety concerns arose during the study, and the side-effects attributable to BLX-883 and Intron A were comparable. Bioactivity of the two agents was also compared, and the elevation of specific immune system markers, such as neopterin, measured after administration of BLX-883 was consistent to the elevation measured after administration of Intron A.
Biolex has selected hepatitis C as the first indication for the commercialization of its alfa interferon program. In February 2005, Biolex formed a partnership with OctoPlus, a drug delivery and development company based in the Netherlands, for the joint development of a controlled-release formulation of alfa interferon. The product under joint development, Locteron, combines BLX-883 with OctoPlus’ proprietary biodegradable PolyActive drug delivery technology, and is designed to be a best-in-class therapeutic for patients with chronic hepatitis C.
“The phase I results make us even more optimistic about the potential of Locteron to offer patients with chronic hepatitis C a more convenient, controlled-release interferon that may be better tolerated than currently available pegylated interferon therapies,” commented Jan Turek, CEO of Biolex.