Protalix BioTherapeutics, Inc.PLX announced positive interim data from a phase I/II study on PRX-102 (1mg/kg) for the treatment of Fabry disease. The company said that the efficacy data for the 1 mg dose seemed more robust than the previously announced 0.2 mg data. Moreover, a favorable safety profile was maintained along with a very low level of antibody formation.
The open-label, dose escalation study is evaluating three doses (0.2 mg/kg, 1mg/kg and 2mg/kg) of PRX-102. Longer term data from the first cohort - 0.2mg/kg are expected by the end of this month, while complete top-line results from all cohorts are expected in the fourth quarter of 2015.
An end-of-phase II meeting has been scheduled with the FDA to discuss the design of the pivotal phase III study, which is expected by year-end. The company expects to initiate the study in early 2016.
We note that Amicus Therapeutics' FOLD Galafold, is currently, under EU review for the treatment of Fabry disease. The company plans to submit a New Drug Application for the candidate in the second half of 2015. Timely approval in the EU would allow the company to launch Galafold in the first half of 2016.
Protalix carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD and Regeneron Pharmaceuticals, Inc. REGN , both sporting a Zacks Rank #1 (Strong Buy).
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