Protalix BioTherapeutics Enrolls First Patient in Phase II Clinical Trial of OPRX-106 for the Treatment of Ulcerative Colitis

CARMIEL, Israel, Nov. 30, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT: PLX) PLX, announced today that the first patient has been enrolled in its phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis.  OPRX-106 is a plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc).

"With the enrollment of the first patient in our OPRX-106 phase II trial, clinical studies are now underway for our three lead assets," said Mr. Moshe Manor, Protalix's President and Chief Executive Officer.  "We look forward to announcing phase II data from our AIR DNase^TM clinical program around year-end, and data from our OPRX-106 phase II clinical trial in the second half of 2017."

The phase II clinical trial is a randomized, open label, 2-arm study of OPRX-106 in 20 patients with active mild to moderate ulcerative colitis.  Patients will be randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily, for 8 weeks.  The primary endpoint of the study is safety, including monitoring for adverse events following daily administration of the drug.  Key efficacy endpoints include relevant disease parameters of the drug, including Mayo score and rectal bleeding. If successful, OPRX-106 will be the first ever oral enzyme treatment as currently there are no other oral enzyme treatments available.

The Company completed a phase I clinical trial of OPRX-106 in 15 healthy volunteers, and the drug was found to be safe and well tolerated.  The results of the phase I clinical trial were announced in August 2015.  Immunomodulatory effect was observed, including activation of T Regulatory cells showing biological activity in the gut.  In addition, early efficacy signals of OPRX-106 have been demonstrated in preclinical studies using inflammatory bowel disease immune-mediated mouse models.  The results of the preclinical studies show that OPRX-106 attributes to a positive change in symptoms and in serum levels of anti-inflammatory markers.

About Protalix BioTherapeutics, Inc.

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 (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: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-106, an orally-delivered anti-inflammatory treatment; PRX-110 for the treatment of Cystic Fibrosis; and others.

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