Protalix is a bio-pharmaceutical company highly focused on and committed to developing and commercializing recombinant proteins with therapeutic potential through its own system of plant cell-based expression, the ProCellEx. The company’s technique is an exquisite way of developing recombinant proteins at affordable costs on potentially large industrial scales. The first product that resulted from this system was taliglucerase alfa, which has already been approved by the United States Food and Drug Administration (FDA), Israel’s Ministry of Health, Brazilian National Health Surveillance Agency (ANVISA), Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Australian Therapeutic Goods Administration (TGA) and other national health authorities.
According to a recent press release, Protalix’s development pipeline currently includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-112, an orally-delivered glucocerebrosidase enzyme that is produced and encapsulated within carrot cells, also for the treatment of Gaucher disease; PRX-106, an orally-delivered treatment for the treatment of Inflammatory Bowel Disease; PRX-110 for the treatment of Cystic Fibrosis; and others.
Protalix is developing PRX-106 to treat IBD, an immune reaction to the host’s intestinal microflora that result in imbalance between the beneficial and commensal microflora within the human gut, ultimately leading to a serious inflammatory response; it can be triggered by genetics, environmental or physiologic factors. The oral anti-TNF is in fact a new way of administering an anti-TNF recombinant protein. Protalix plans to begin the trials in a non-IND setting during 2015 and to collaborate with a well-suited partner to continue the development of the drug, right after reviewing the proof of concept (POC) data that is expected to be available in 2016.
2014 has been a rich year regarding breakthroughs into understanding and treating IBD. Protalix’s commitment to developing PRX-106 represents a new effort for 2015 that hopefully will be translated into new treatment opportunities for such patients.