Berlex Laboratories Inc announced a phase III study will be initiated with Leukine (sargramostim) as a potential treatment for patients with Crohn's disease. The decision follows review of data in which positive results were obtained from a recently completed multi-center, randomized, double-blind, placebo-controlled study of 124 patients with moderately to severely active Crohn's disease.

"We are optimistic about the initial review of the data from the most-recent Leukine Crohn's disease trial," said Reinhard Franzen, president and chief executive officer, Berlex Laboratories Inc. "Crohn's disease is a chronic and serious inflammatory disease with no known cause. Our goal is to offer a novel approach to the treatment of this serious disease."

Detailed results of the study are being submitted to a peer-reviewed medical journal and also are expected to be presented at upcoming scientific meetings. Until then, to comply with agreements pertaining to journal publications and meeting presentations, no further data from the study will be available.