Nerve gas antidote completes phase I trial
pharmafile | June 9, 2010 | News story | Research and Development | Protalix, biodefence
Israeli biotech firm Protalix has completed a phase I clinical trial for its intravenous nerve gas antidote.
The drug is being developed for use primarily within the military as an antidote to civilian use of nerve gas, including protection against organic phosphorous compounds used in pest-control chemicals.
PRX-105 is derived from Protalix’s ProCellEx proprietary plant cell-based expression system that delivers recombinant therapeutic proteins.
Given the nature of the biodefence indications for which Protalix is developing PRX-105, phase II and phase III trials will not required.
The company plans to perform additional safety studies in healthy volunteers and animals in collaboration with civil and military agencies in the US and Israel, for which discussions have been initiated.
The phase I clinical trial of PRX-105 is a first in human, open label, non-randomised, single-dose study. Drug the trial PRX-105 was administered intravenously by slow bolus injection to 10 healthy volunteers.
Dr David Aviezer, Protalix’s president and chief executive, said: “We are very pleased with the favourable safety and pharmacokinetic results from our phase I clinical trial of PRX-105.
“The positive results also provide further validation of the safety and breadth of our ProCellEx plant cell-based expression system.”
Pfizer collaboration for Gaucher disease
Meanwhile, Protalix’s drug candidate for Gaucher disease taliglucerase alfa is currently being considered by US and European regulators.
The US FDA granted it orphan drug status last year and in January this year advisors to its European counterpart recommended the EMA follow suit.
Taliglucerase alfa is an enzyme replacement therapy in development under a Special Protocol Assessment with the FDA for Gaucher disease.
The drug is being developed in collaboration with Pfizer, which has exclusive, worldwide rights to commercialise it, except in Israel, where Protalix remain the license holders.
Ben Adams
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