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Yokne'am-based Protalix is beginning the phase III clinical trial of prGCD, a proprietary plant cell expressed recombinant form of human glucocerebrosidase (GCD) for the treatment of Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans.
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Protalix president and CEO Dr. David Aviezer said, "We expect to analyze the results of this key study and to report the results in the second half of 2009. We anticipate submitting a New Drug Application to the US Food and Drug Administration (FDA) and other comparable regulatory agencies in the fourth quarter of 2009."
Protalix hopes that the trial will demonstrate that its treatment for Gaucher disease is of equal value to the drug by Genzyme Inc. (NYSE: DNA) that is already on the market.
Vancouver-based Allon Therapeutics is conducting its Phase II clinical trial evaluating the safety and efficacy of its proprietary drug candidate AL-108 for treatment of schizophrenia-related cognitive impairment. The company expects to publish results in 2009. The US National Institute of Mental Health and TURNS (Treatment Units for Research on Neurocognition and Schizophrenia) are funding the trial, and TURNS is managing it.
Allon president and CEO Gordon McCauley said that if the trial is successful, AL-108 might be applicable beyond Alzheimer's disease. The company was founded in Israel by Ramot at Tel Aviv University Ltd., the university's technology transfer arm, on the basis of technology developed by the company's chief scientist, Prof. Ilana Gozes of the university's Sackler School of Medicine.
Protalix rose 3 percent yesterday to $1.39, giving a market cap of $105 million. Allon Therapeutics closed at $0.37 yesterday.
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