Rochester, NY 7/7/2009 3:36:37 AM
End of Day Report - PLX - Protalix BioTherapeutics Asked to Consider Submitting Treatment for Gaucher Disease - Sourced WhisperFromWallStreet.com
Protalix BioTherapeutics, Inc.
End of Day Report - PLX - Protalix BioTherapeutics Asked to Consider Submitting Treatment for Gaucher Disease - Sourced WhisperFromWallStreet.com
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PROTALIX BIOTHERAPEU,PLX
Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that it was approached by the U.S. Food and Drug Administration (FDA) and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme®, a mammalian cell expressed version of glucocerebrosidase (GCD) and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. prGCD, the Company’s lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase III clinical trial for the treatment of Gaucher disease. The FDA indicated to the Company that it believes the Company’s development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol. Under current FDA regulations, a treatment protocol may be submitted for a drug that has not yet been approved for marketing but is the subject of clinical development for a serious or life threatening disease for which no comparable or satisfactory alternative drug or therapy is available. The Company and the FDA are discussing the parameters of a proposed treatment protocol which would allow an increased number of patients with Gaucher disease to have access to prGCD. The Company expects to submit a treatment protocol to the FDA for its review as a supplement to the Company’s current Investigational New Drug (IND) application for prGCD.
About
Protalix BioTherapeutics, Inc., a biopharmaceutical company, engages in the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system in the United States. Its lead product candidate includes prGCD, a proprietary plant cell expressed recombinant Glucocerebrosidase enzyme for the treatment of Gaucher disease, which is in Phase III clinical trial. The company also develops PRX-102, a proprietary alpha Galactosidase enzyme for the treatment of Fabry disease, a genetic lysosomal storage disorder in humans, the symptoms of which involve the accumulation of lipids in the cells of the kidneys, heart, and other organs; a proprietary plant cell-based acetylcholinestrase and its molecular variants for use in various therapeutic and prophylactic indications, including a Biodefense program; and an organophosphate-based pesticide treatment program.
Last Trade: 4.88
Day's Range: 4.88 - 5.85
52wk Range: 1.80 - 40.00
Volume: 1,960,332
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