Protalix Presents Additional Phase III Data for taliglucerase alfa at the WORLD Symposium
February 11 2010 - 10:30AM
PR Newswire (US)
CARMIEL, Israel, Feb. 11 /PRNewswire-FirstCall/ -- Protalix
BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today that
additional data from the Company's pivotal Phase III clinical trial
of taliglucerase alfa in patients with Gaucher disease was
presented at the Annual Meeting of the Lysosomal Disease Network:
WORLD Symposium 2010 in Miami, Florida, during an oral session
titled, "Novel Enzyme Replacement Therapy for Gaucher Disease:
Phase III Pivotal Clinical Trial with Plant Cell Expressed
Recombinant Glucocerebrosidase (prGCD) - taliglucerase alfa." The
oral presentation was made by Hanna Rosenbaum M.D., Director of
Hematology Day Care Unit, RAMBAM Medical Center, Haifa, Israel, and
study investigator. "I believe the data from the Phase III trial
demonstrates that taliglucerase alfa is well tolerated and
clinically effective in treating Gaucher disease," said Dr. Hanna
Rosenbaum. The pivotal Phase III clinical trial was a multi-center,
world-wide, 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 20% 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 enrolled
patients at 11 centers throughout Europe, Israel, North America,
South America and South Africa. 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%
(p