PROGENICS ANNOUNCES POSITIVE RESULTS FROM PHASE II TRIAL OF MNTX

Progenics Pharmaceuticals has announced positive top-line results from a Phase II clinical trial of its investigational drug, methylnaltrexone (MNTX) for the management of postoperative bowel dysfunction.

Patients who received MNTX following major abdominal surgery exhibited an acceleration of gastrointestinal recovery by at least one day on average compared to placebo. Significant improvements were seen in clinically important measures of gastrointestinal recovery: time to first bowel movement and discharge eligibility from the hospital.

MNTX was generally well-tolerated in this study, with no reports of serious adverse events related to the drug.

A total of 65 patients at eight surgical centers participated in the double-blind, randomized, placebo-controlled Phase II trial. Subjects underwent segmental colectomies -- removal of a portion of the colon -- primarily due to cancer or diverticular disease. Shortly after surgery, study medication (0.3 mg/kg MNTX or placebo) was administered intravenously at six-hour intervals for a maximum of seven days. This proof-of-concept Phase II study was designed to investigate the activity and tolerability of MNTX in the postoperative setting.