Neose opts to delays NE-180 U.S. trial amid safety questions

By Elaine Rigoli

Tampa, Fla., July 11 - Neose Technologies, Inc. said it will delay the U.S. trial for NE-180 after the Food and Drug Administration raised additional questions with regard to the reliability of the existing potency assay as a measurement of product stability for the company's glycoPEGylated erythropoietin for the treatment of anemia.

Neose said it continues to work on its NE-180 clinical hold, and as previously announced, the initial FDA hold items were successfully addressed.

Neose said it expects to address these new questions during the next three quarters.

In related news, the company said it has concluded the dosing and safety follow-up for its phase 1 trial in Western Europe. Final analyses of pharmacokinetic data and other parameters are ongoing.

"We are pleased with the data we have seen thus far in the phase 1 trial. The initial stopping criteria, based on increases in hemoglobin, were met after dosing the first two of the four planned dose groups. Although we added an option to dose additional subjects to gain more data, we have elected to end the study at this point given the issues surrounding the reliability of our potency assay," president and chief executive officer George J. Vergis said in a news release.

"We believe we have sufficient clinical data and expect to commence phase 2 in Western Europe as planned in the fourth quarter of 2006."

Neose Technologies is a clinical-stage biopharmaceutical company based in Horsham, Pa.

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