Protalix BioTherapeutics Announces Final Dosing of Last Patient in Phase II Clinical Trial of OPRX-106 in Patients with Ulcerative Colitis
CARMIEL, Israel, Feb. 15, 2018 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), announced today the final dosing of the last patient in the Company’s phase II clinical trial evaluating OPRX-106, the Company’s oral antiTNF product candidate, in patients with ulcerative colitis (UC). OPRX-106 is the Company’s proprietary plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc). The Company expects to report top-line results from this study by the end of March 2018.
“Given the positive preliminary data we have reported already, we are excited to be nearing the completion of this study,” said Mr. Moshe Manor, Protalix’s President and Chief Executive Officer.
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.
About Protalix BioTherapeutics, Inc.
Protalix (PLX) 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 (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights. Protalix’s development pipeline includes the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and others. Protalix has entered into an ex-United States partnership with Chiesi Farmaceutici S.p.A. for the development and commercialization of pegunigalsidase alfa. Protalix maintains full rights to pegunigalsidase alfa in the United States.
