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December 2, 2008

Protalix BioTherapeutics Announces Completion of Enrollment for its Pivotal Phase III Clinical Trial of Gaucher Disease

Protalix BioTherapeutics, Inc. (Amex: PLX), announced today that it has completed enrollment in the Company’s pivotal phase III clinical trial of prGCD, a proprietary plant cell expressed recombinant form of human glucocerebrosidase (GCD) for the treatment of Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans.

“The completion of enrollment signifies that we are one important step closer to our goal of commercializing prGCD," said Dr. David Aviezer, President and Chief Executive Officer of Protalix BioTherapeutics. "We expect to analyze the results of this key study and to report the results in the second half of 2009. We anticipate submitting a New Drug Application (NDA) to the FDA and other comparable regulatory agencies in the fourth quarter of 2009."

The Company’s phase III clinical trial of prGCD is designed as a multi-center, randomized, double-blind, parallel group, dose-ranging trial to assess the safety and efficacy of prGCD in naive patients suffering from Gaucher disease. In the trial, patients are selected randomly for one of two dosing arms and receive IV infusions every two weeks for nine months. The primary endpoint of the study is the change, calculated in percentages, in spleen volume from baseline, as measured by MRI.

“I am very encouraged by the progress of the study and the patient responses demonstrated to date” said Professor Ari Zimran, Director of the Gaucher Clinic at Shaare Zedek Medical Center in Jerusalem and a Principal Investigator of the Company’s pivotal Phase III trial of prGCD. Dr. Rene Heitner, a Pediatrician at the Morningside clinic in South Africa and a Principal Investigator of the phase III clinical trial of prGCD said “At our clinical site, patients appear to be tolerating and progressing very well on the bi-weekly infusions of prGCD.”

The Company’s pivotal phase III clinical trial of prGCD is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). An SPA is a procedure by which sponsors and the FDA reach agreement on the design and size of clinical trials intended to form the primary basis to support approval of a New Drug Application. There have been no Serious Adverse Events reported in connection with the phase III clinical trial.

Source: Business Wire (December 2, 2008 - 8:51 AM EST)

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