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Protalix BioTherapeutics' Taliglucerase Alfa Phase III Results Published In Blood, The Journal Of The American Society Of Hematology

CARMIEL, Israel, Sept. 8, 2011 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX), today announced that an article entitled "Pivotal Trial with Plant-Cell–Expressed Recombinant Glucocerebrosidase, taliglucerase alfa, a Novel Enzyme Replacement Therapy for Gaucher Disease" has been published in Blood, the Journal of the American Society of Hematology.  The full article can be found on the American Society of Hematology's website at http://bloodjournal.hematologylibrary.org. (First Edition Paper, pre-published online September 6, 2011; DOI 10.1182/blood-2011-07-366955)

The reported study is based on the Company's phase III clinical trial of taliglucerase alfa for the treatment of Gaucher disease.  The authors, who include among others specialists in the treatment of Gaucher disease that served as investigators in our phase III clinical trial, concluded that treatment of 31 naive Gaucher disease patients with taliglucerase alfa at doses of 60 U/kg or 30 U/kg administered intravenously every two weeks for nine months reduced mean spleen volume by 38.0 percent and 26.9 percent, respectively.  Additionally, patients treated with taliglucerase alfa in the phase III clinical trial demonstrated an increase in hemoglobin, decrease in liver volume and increase in platelet count.

"The sustained efficacy and safety that we observed among Gaucher patients receiving taliglucerase alfa in this study suggests that it is a valuable long-term treatment option for patients with Gaucher disease pending regulatory approval," stated Professor Ari Zimran, M.D., Director of the Gaucher Clinic in Shaare Zedek Medical Center, Jerusalem, Israel and lead clinical investigator.  

Phase III Trial Design

The pivotal Phase III clinical trial was a world-wide, multi-center, randomized, double-blind, parallel group, dose-ranging study to assess the safety and efficacy of taliglucerase alfa in 31 treatment-naive patients suffering from Gaucher disease.  In the trial, patients were selected randomly for one of two dosing arms (60 U/kg or 30 U/kg) and received intravenous infusions of taliglucerase alfa once every two weeks for a nine month period.  The primary endpoint of the study was a mean reduction from baseline in spleen volume after nine months, as measured by MRI. Major secondary endpoints were an increase in hemoglobin, decrease in liver volume and increase in platelet count.  The trial was performed in 11 centers throughout Europe, Israel, North America, South America and South Africa.

Phase III Trial Results

Taliglucerase alfa significantly reduced mean spleen volume after nine months compared with baseline in both treatment groups.  The 60 U/kg group demonstrated a statistically significant mean reduction in spleen volume of 38.0 percent (p<0.0001) and the 30 U/kg group demonstrated a statistically significant mean reduction in spleen volume of 26.9 percent (p<0.0001).  In addition, the primary endpoint was achieved in both treatment groups after only six months of therapy.

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