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|Protalix BioTherapeutics Announces Final Dosing of Last Patient in Phase II Clinical Trial of OPRX-106 in Patients with Ulcerative Colitis|
“Given the positive preliminary data we have reported already, we are excited to be nearing the completion of this study,” said Mr.
The phase II clinical trial is a randomized, open label, 2-arm study of OPRX-106. Twenty-four patients were enrolled in the phase II study and were randomized to receive 2 mg or 8 mg of OPRX-106, administered orally, once daily, for 8 weeks, and 18 patients completed the trial. Key efficacy endpoints of the study, in addition to safety, include relevant disease parameters of the drug, including Mayo score and rectal bleeding.
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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