Progenics Achieves Enrollment Target in Pivotal Phase 3 Clinical Trial of Methylnaltrexone for Opioid-Induced Constipation
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Dec. 3, 2004--Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that it has reached the target enrollment in the first of two pivotal phase 3 clinical trials of its investigational drug, methylnaltrexone (MNTX) for the treatment of opioid-induced constipation in patients with advanced medical illness (AMI). The Company expects to announce top-line results from the 150-patient, multi-center, double-blind, randomized, placebo-controlled phase 3 study in early 2005.
Over one million deaths occur each year in the U.S. from cancer, AIDS, sickle cell disease and other forms of AMI. Many of these patients receive opioids for pain prior to their death and as a result suffer debilitating opioid-related side effects, particularly constipation.
"To our knowledge, this phase 3 trial is the first pivotal study ever conducted entirely in this population of patients - those with terminal disease and six months or less to live," said Robert J. Israel, M.D., Progenics' Senior Vice President, Medical Affairs. "Opioid-induced constipation is a serious unmet medical need and we are grateful to these patients and their physicians for participating in this landmark hospice-based study."
This study was conducted at 16 hospices in the U.S. Patients were randomized to receive a single subcutaneous injection of either placebo or one of two doses of MNTX (0.15 mg/kg or 0.30 mg/kg). The primary end point was the relief of constipation within four hours after receiving study medication. The trial also included a four-week open-label period in which patients were eligible to receive MNTX as required.
Progenics is pursuing three different indications for MNTX which correspond to three dosage forms. 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.
-- In AMI, MNTX is being studied in two, pivotal phase 3 clinical
trials in opioid-induced constipation using the subcutaneous
form. The second MNTX phase 3 study is expected to complete
enrollment in mid-2005. If these results are positive, a New
Drug Application is scheduled to be filed with the U.S. Food
and Drug Administration by the end of 2005.
-- A phase 2 study of intravenous MNTX for relief of
post-operative ileus completed enrollment in October, and
top-line results are expected in early 2005.
-- The Company has completed two phase 1 clinical studies of oral
MNTX in healthy volunteers and is preparing to begin a phase 2
clinical trail for relief of opioid-induced constipation in
patients with chronic pain.
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