Neose seeks European approval for phase 1 trial of NE-180

By E. Janene Geiss

Philadelphia, Dec. 22 - Neose Technologies, Inc. said it filed for approval to start a phase 1 clinical trial in a European regulatory jurisdiction for its drug candidate NE-180 (GlycoPEG-EPO), a long-acting version of erythropoietin.

The company said, pending approval, it is prepared to begin the trial in the first quarter of 2006 using its current clinical drug supply and its contract research partner, according to a company news release.

Neose said it has been pursuing parallel efforts in the United States and Europe to move NE-180 into clinical trials.

The company said it is delaying until early 2006 the submission of its complete response to the U.S. Food and Drug Administration. Taking more time will enable the company to complete the additional information required by the FDA, officials said.

Neose is a Horsham, Pa., biopharmaceutical company using its proprietary enzymatic technologies to develop improved drugs, focusing primarily on therapeutic proteins.

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