Protalix Biotherapeutics Inc. (AMEX:PLX; TASE: PLX) today reported success in a Phase I clinical trial of its oral treatment of Gaucher's disease. The study found that oral glucocerebrosidase (GCD) was well-tolerated, and active enzyme was detected in patients' blood circulation.
Oral GCD uses the same active ingredient used is the company's approved intravenous enzyme replacement therapy, Elelyso. It is an active form of human GCD which is naturally encapsulated within the carrot cells in which it is produced.
Protalix will now have to demonstrate that the enzyme from oral GCD can reach the bloodstream in controllable dosages, and that it can influence the condition of a Gaucher disease patient.
The study, conducted at Shaare Zedek Medical Center in Jerusalem and at the Rambam Medical Center in Haifa, included 12 patients. There were no serious adverse reactions reported and no patient discontinued the study prematurely. The company said that it will now expand the study, although it did not say to what size. The expanded study will verify the safety and efficacy data in the hope of obtaining easements in the expanded efficacy studies. The expanded study will be completed this year.
Protalix's share price rose 5.2% by late afternoon on the TASE to NIS 15.96, and by 5.8% at the opening on the American Stock Exchange to $4.52, giving a market cap of $417 million.
Published by Globes [online], Israel business news - www.globes-online.com - on October 14, 2013
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