Protalix Bio (PLX) Anounces Pivitol Phase III UPLYSO Results
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Protalix BioTherapeutics, Inc. (AMEX: PLX) announced today positive top-line results from the Company's pivotal Phase III clinical trial of UPLYSO (taliglucerase alfa, previously referred to as prGCD) in treatment naive patients diagnosed with Gaucher disease.
The trial met its primary endpoint, mean reduction in spleen volume after nine months compared with baselines. The endpoint was met by both the 60 U/kg dose and in the lower 30 U/kg dose treatment groups (P<0.0001). The primary endpoint was stipulated in the Special Protocol Assessment (SPA) agreed on by the Company and the U.S. Food and Drug Administration (the "FDA") prior to the commencement of the trial.
Statistically significant improvements compared with baselines were also observed in the secondary endpoints, including increase in hemoglobin level, decrease in liver size and increase in platelet count at the 60 U/kg dose.
The safety analysis for both doses showed that UPLYSO was well tolerated and no serious adverse events were reported. Most adverse events were mild in intensity and not drug related and were transient in nature.
The trial met its primary endpoint, mean reduction in spleen volume after nine months compared with baselines. The endpoint was met by both the 60 U/kg dose and in the lower 30 U/kg dose treatment groups (P<0.0001). The primary endpoint was stipulated in the Special Protocol Assessment (SPA) agreed on by the Company and the U.S. Food and Drug Administration (the "FDA") prior to the commencement of the trial.
Statistically significant improvements compared with baselines were also observed in the secondary endpoints, including increase in hemoglobin level, decrease in liver size and increase in platelet count at the 60 U/kg dose.
The safety analysis for both doses showed that UPLYSO was well tolerated and no serious adverse events were reported. Most adverse events were mild in intensity and not drug related and were transient in nature.
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