Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD. Phase III clinical trial may commence shortly

Protalix BioTherapeutics, Inc. (Amex: PLX - News) today announced that it has received written notice from the United States Food and Drug Administration (FDA) that it may initiate a Phase III clinical trial in the United States of its lead product candidate, prGCD, a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD), for the treatment of Gaucher Disease, a lysosomal storage disorder in humans.

CARMIEL, Israel | Apr 18, 2007 |
Protalix BioTherapeutics, Inc. (Amex: PLX - News) today announced that it has received written notice from the United States Food and Drug Administration (FDA) that it may initiate a Phase III clinical trial in the United States of its lead product candidate, prGCD, a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD), for the treatment of Gaucher Disease, a lysosomal storage disorder in humans. The FDA has allowed the Company to directly initiate Phase III based upon the results of the Company's pre clinical and Phase I clinical trials of prGCD. The Company presented the completed data from its Phase I clinical trial at the European Working Group of Gaucher Disease (WEGGD) in Cambridge, United Kingdom in July 2006. The Company hopes to commence the Phase III clinical trial shortly. The trial will take place in centers in the United States, Israel, where approval from the Israeli Ministry of Health has been received, and other locations worldwide. The study will initially consist of male and female adult patients with Gaucher Disease. David Aviezer, Ph.D., President and Chief Executive Officer of Protalix BioTherapeutics, commented, "The receipt of the FDA's approval to initiate a Phase III clinical trial of prGCD represents an important milestone in the development of this product, and we are excited about the progress we have made thus far. Following the success of our Phase I trial and our promising pre clinical and biochemical data, we believe that we will continue to see positive results from our patients in Phase III." Dr. Aviezer continued, "We remain deeply committed to the development of a treatment for Gaucher Disease and are excited by the opportunity to commence the Phase III trial and working with the medical experts and patient community."

About Protalix BioTherapeutics, Inc.

Protalix's proprietary technology is based on its plant cell culture and bioreactor system, which provides an effective and scaleable cell system for industrial production of recombinant biopharmaceuticals. Protalix is pursuing advanced clinical studies for its enzyme therapy for Gaucher Disease and intends to advance additional recombinant biopharmaceutical drug development programs. The Company believes its plant-based expression has significant advantages over more traditional mammalian and bacterial expression technology with respect to patient safety, cost and scalability.


SOURCE: Protalix BioTherapeutics, Inc.

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