Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Biolex Therapeutics has successfully completed a phase I clinical trial of BLX-883, a form of alfa interferon, in healthy volunteers.
Subscribe to our email newsletter
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.