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.Private protein therapeutics company Biolex Inc has submitted applications to the FDA and the UK MHRA seeking approval for phase I clinical trials of a form of alfa interferon, a protein used to treat infectious diseases and some cancers.
Subscribe to our email newsletter
The alpha interferon, BLX-883, will be the first product manufactured using Biolex’ proprietary LEX System to enter the clinic. The study is designed to evaluate safety, pharmacokinetics and pharmacodynamics of the product.
Alfa interferon is a recombinant human protein used to treat infectious diseases such as hepatitis C and certain cancers. In pre-clinical studies, BLX-883 produced with the LEX System had the same specific activity in in-vitro antiviral and anticancer assays and was shown in-vivo in monkey studies to be comparable in both potency and pharmacokinetics to Schering Corporation’s commercially available Intron A.
“We are excited to begin human studies for the first product to enter the clinic that is produced in a contained and controlled plant transgenic system,” said Jan Turek, president and CEO of Biolex. “There is tremendous need for improved and more efficient approaches to production of hard-to-make therapeutic proteins such as alfa interferon.”
Alfa interferon has an estimated worldwide annual market value of over $3 billion and, utilizing its patented LEX System, Biolex has cGMP manufacturing capability to cost-effectively produce a significant portion of the market need and is seeking a partner for further clinical development and commercialization of BLX-883.