>>TARRYTOWN, N.Y.--(BUSINESS WIRE)--Oct. 7, 2004--Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX - News) today announced that the target enrollment has been reached in the phase 2 study of its investigational drug, methylnaltrexone (MNTX) for the treatment of post-operative ileus (POI). The Company expects to announce top-line results from the 60-patient, multi-center, double-blind, randomized, placebo-controlled study in early 2005. Each year in the U.S., approximately four-million patients undergo surgeries which place them at high risk for developing ileus, a paralysis of the gastrointestinal tract. Ileus is a leading cause of prolonged hospital stay in these cases.
"In this proof-of-concept study, we have enrolled a population of patients who typically are at high risk for prolonged ileus," said Robert J. Israel, M.D., Progenics' Senior Vice President of Medical Affairs. "Specifically, all of the patients on the study underwent segmental colectomies, a removal of a portion of their colon, usually for cancer. This trial was designed to evaluate the clinical utility of MNTX to restore promptly gastrointestinal function and to shorten hospital stay. There is currently no approved therapy for POI, and we believe that MNTX may improve the resolution of ileus."
Progenics is pursuing three different indications for MNTX which correspond to three dosage forms: In advanced medical illness, MNTX is being studied in two, pivotal phase 3 clinical trials in opioid-induced constipation using the subcutaneous form. MNTX is being studied for the treatment of post-operative ileus by intravenous dosage, and oral MNTX for relief of opioid-induced constipation in patients with chronic pain. The Company believes that the ability to deliver MNTX using three dosage forms and routes of administration represents a significant benefit. Each form is potentially useful in a variety of clinical applications where rapid onset of action, dosing flexibility, and ease of use can be tailored to fit the needs of the patient. <<
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