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Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) today reported that its treatment for Gaucher's disease Uplyso (taliglucerase alfa) reduces the average mean spleen volume after 24 months. New clinical data from the extension trial found statistically significant results in the two treatment groups, compared with the baseline. Patients with hepatomegaly (enlarged liver) also showed a 25.2% reduction in liver volume.
Protalix is presenting the data at the Lysosomal Disease Network: World Symposium 2012 now underway in San Diego. Taliglucerase alfa is the company's proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD), which is being developed for the treatment of Gaucher disease. The Phase III clinical trial extension trial includes 26 patients at medical centers in Europe, Israel, North and South America, and South Africa.
"Pivotal and follow-up clinical studies of taliglucerase alfa to date demonstrate that taliglucerase alfa may be an effective treatment for Gaucher disease," said Dr. Ari Zimran, Director of the Gaucher Clinic, Shaare Zedek Medical Center in Jerusalem. "The results of this 24 month extension trial suggest that taliglucerase alfa has the potential to become a treatment alternative for Gaucher disease patients should it be approved."
Protalix has filed marketing applications for Uplyso in the US, Europe, Israel, Brazil and Australia. It expects the US Food and Drug Administration (FDA) response by May 1, 2012.
Protalix's share price closed at $6.51 on the American Stock Exchange yesterday, giving a market cap of $557 million. There is no trading on the Tel Aviv Stock Exchange (TASE), due to a strike.
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