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Protalix BioTherapeutics Announces First Patient Treated In Phase I/II Study Of Fabry Patients With PRX-102

CARMIEL, Israel, Dec. 10, 2012 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX), announced today that the first patient has been treated in the Company's phase I/II clinical trial of Fabry patients with PRX-102. PRX-102 is the Company's proprietary plant cell-expressed, chemically modified recombinant alpha-galactosidase-A enzyme in development as a long-term enzyme replacement therapy (ERT) for the treatment of Fabry disease. 

"We are pleased to have PRX-102 enter the clinic this year as planned. We believe PRX-102 may eventually serve as an alternative treatment for Fabry patients with the potential to be an improved enzyme replacement therapy," said Dr. Einat Brill Almon, the Company's Senior Vice President, Product Development. "PRX-102 is manufactured using ProCellEx®, our proprietary recombinant protein expression system which uses genetically engineered plant cells to produce specific protein products.  ELELYSO TM, our first commercial product which was approved by the U.S. Food and Drug Administration in May 2012, is also manufactured through ProCellEx."

The phase I/II clinical trial is a worldwide, multi-center, open label, dose ranging study to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy parameters of PRX-102 in adult Fabry patients.  The trial is designed to enroll 18 adult Fabry patients, each in one of three dosing groups. Each patient will receive intravenous infusions of PRX-102 every two weeks for 12 weeks.  After the completion of the protocol, the Company intends to offer enrolled trial patients the option to continue to receive PRX-102 in an open-label extension study.

About Protalix

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, ELELYSO™ (taliglucerase alfa), was approved for marketing by the U.S. Food and Drug Administration on May 1, 2012 and by Israel's Ministry of Health in September 2012.  Protalix has partnered with Pfizer Inc. for the worldwide development and commercialization of ELELYSO™, excluding Israel, where Protalix retains full rights. Marketing applications for taliglucerase alfa have been filed in additional territories as well. Protalix's development pipeline also 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-105, a pegylated recombinant human acetylcholinesterase in development for several therapeutic and prophylactic indications, a biodefense program and an organophosphate-based pesticide treatment program; an orally-delivered glucocerebrosidase enzyme that is naturally encased in carrot cells, also for the treatment of Gaucher disease; pr-antiTNF, a similar plant cell version of etanercept (Enbrel®) for the treatment of certain immune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis; and others.

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