FDA News

Neose Receives FDA Clearance to Commence U.S. Clinical Trials for NE-180

(March 15, 2007)--Neose Technologies said that it has received clearance from the United States Food and Drug Administration (FDA) to commence clinical trials for NE-180 in the United States. NE-180 is a long-acting, GlycoPEGylated erythropoietin (EPO) being developed for the treatment of anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy and for the treatment of anemia associated with chronic kidney disease, including patients on dialysis and patients not on dialysis. NE-180 is currently in a Phase II trial for oncology-related anemia in Switzerland.

“We are pleased to come off clinical hold with the FDA. This clearance provides us the opportunity to include the United States in our global drug development program for NE-180,” said George J. Vergis, Ph.D., Neose president and chief executive officer.

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