Protalix Biotherapeutics Inc. (AMEX:PLX) today announced positive results in its Phase III clinical trial of its drug for the treatment of Gaucher's Disease. The drug, UPLYSO (taliglucerase alfa) was previously referred to as prGCD, was found to be safe, with no serious side effects, and no patients developed neutralizing antibodies to the drug.
The trial achieved its primary goal, which was a mean reduction in spleen volume after nine months, compared with the baseline for both dosages of the drug, as stipulated in the trial protocol approved by the US Food and Drug Administration (FDA). The trial also achieved statistically significant improvements, compared with baselines, in the secondary goals, including increase in hemoglobin level, decrease in liver size, and an increase in the platelet count.
Protalix will present more comprehensive results shortly, as well as at upcoming medical meetings.
Protalix president and CEO Dr. David Aviezer said, “We expect to complete the ongoing rolling New Drug Application (NDA) submission for marketing clearance with FDA before the end of this year. In addition, these results further validate our ProCellEx platform for the expression of safe and efficacious human therapeutic proteins in plant cell cultures, and set the ground for many other lucrative opportunities."
Protalix rose over 6% at the opening on the American Stock Exchange today to $9.80, giving a market cap of $680 million.
Published by Globes [online], Israel business news - www.globes-online.com - on October 15, 2009
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