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Protalix BioTherapeutics Reports Positive Phase I Clinical Study Results for PRX-106 Oral Anti-TNF
The Phase I trial is a randomized, parallel-design, open-label study designed to evaluate the safety and pharmacokinetics of PRX-106 in healthy volunteers. The trial enrolled 14 subjects that were randomized to one of three dosing cohorts receiving PRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects received once daily oral administrations for 5 consecutive days.
The results demonstrated that oral administration of PRX-106 is safe and well tolerated. No major side effects were noted, and no suppression of the immune system was observed. Regulatory T cell activation showing biological activity in the gut was observed. Fluorescence-activated cell sorting analysis (FACS) was performed using various antibodies for surface markers, and it was observed that all three dosages of PRX-106 promoted the induction of various subsets of T cells, some of which are correlated with anti-inflammatory response.
"The results demonstrated in the Phase I trial are very exciting and encouraging. As T regulatory cells have a central role in the immune system, PRX-106 has the potential to be an effective agent for numerous immune-mediated indications," said Prof.
In preclinical studies evaluating oral PRX-106 the compound alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A immune mediated hepatitis mouse model. Additionally, oral administration of PRX-106 alleviated immune mediated colitis in a well-established mouse model, promoting serum levels of anti-inflammatory IL-10 and regulatory T-cells.
Protalix is currently evaluating the best indication to take forward with PRX-106. The Company anticipates identifying this shortly and initiating a proof of concept trial in patients around year end.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration(
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CONTACT: Investor Contact Marcy Nanus