Enzon Inc. filed an investigational new drug (IND) applicationwith the FDA last week to begin clinical trials on its version ofrecombinant glucocerebrosidase for treating Gaucher's disease.

The drug, PEG-glucocerebrosidase, is a result of acollaborativion between Enzon of Piscataway, N.J., andresearchers at the National Institute of Mental Health (NIMH)of the National Institutes of Health.

Edward Ginns, who heads NIMH's neurogenetics section,developed the recombinant form of the enzyme, while Enzonused its PEG (polyethylene glycol) technology to develop achemically modified form of the drug in an effort to extend itshalf-life in the circulation. Enzon (NASDAQ:ENZN) claims thatthe modification also allows smaller amounts of the drug to beincluded per injection.

Enzon has completed the construction of a manufacturingfacility that will provide sufficient PEG-glucocerebrosidase forthe clinical trials.

"We are preparing to enroll patients for clinical trials at NIMHas soon as we get FDA approval," Ginns said. NIMH's EllenSidransky is the study's principal investigator.

-- Jennifer Van Brunt Senior Editor

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