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Biotech / Medical : progenics -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (69)	12/20/2002 10:26:19 AM
From: tuck	Read Replies (1) \| Respond to of 139

>>TARRYTOWN, N.Y.--(BUSINESS WIRE)--Dec. 20, 2002--Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX - News) announced today that it has initiated a pivotal phase-3 clinical trial of its investigational drug methylnaltrexone (MNTX) for the reversal of opioid-induced constipation. Bowel dysfunction is a debilitating problem for patients with advanced medical illness who are being treated with narcotics for pain. The Company also announced positive preliminary results from its phase-2b study of MNTX in a hospice setting. "Opioid-induced constipation in terminally ill patients is a serious medical problem that frequently has no satisfactory solution," said Charles F. von Gunten, M.D., Ph.D., Medical Director, Center for Palliative Studies at San Diego Hospice and an investigator in the clinical trial. "In this study, methylnaltrexone was well tolerated and rapidly reversed constipation in a majority of treated patients. Methylnaltrexone has the potential to be an important new drug to relieve patient discomfort and suffering." The multi-center phase-2b clinical trial of MNTX for treatment of opioid-induced constipation has randomized 29, of an anticipated 33 patients, to one of four subcutaneous doses of MNTX given every other day for one week. Thereafter, patients could elect to continue on therapy for up to three additional weeks as part of an open-label extension study. During the extension phase, patients were 2.6 times as likely to have a bowel movement within four hours after receiving the highest MNTX dose (12.5 mg) versus the lowest dose (5 mg) analyzed (67% versus 26%, p = 0.04, chi-squared test, two-sided). There was also a significant dose-dependent laxation response to the four doses of MNTX used in the open-label study (p = 0.027, linear trend test, two-sided). Patients entering the clinical trial averaged 1.7 bowel movements per week, which increased to more than three laxations per week during the MNTX treatment phase. Given the excellent tolerability profile of the open-label doses tested, the Company is also exploring higher doses of MNTX in the blinded portion of the study to examine the upper range of the dose-response curve. The Company is initiating its phase-3 clinical program based upon the preliminary positive results of the phase-2b study and the findings of prior clinical trials. Complete results from the phase-2b study are scheduled to be announced early next year. Opioids are widely used to lessen suffering in advanced cancer and other terminal diseases. To relieve pain, narcotic medications such as morphine interact with receptors located in the central nervous system - the brain and spinal cord. Opioids, however, also react with receptors outside of the central nervous system, resulting in side effects which may be debilitating, including constipation, nausea, vomiting, and severe itching. MNTX blocks receptors in the body that cause these side effects. As MNTX does not cross the blood-brain barrier, it does not interfere with brain-centered pain relief. There have been no serious adverse events reported to date related to MNTX in the phase-2b trial. The most common side effects were flatulence and abdominal cramping. These symptoms were interpreted as activation of the gastrointestinal tract, a necessary physiological prerequisite to bowel movement in patients with significant constipation. The cramping was transient, generally less than one hour in duration, and not dose related. As in previous trials, no evidence of opioid withdrawal was observed in the phase-2b trial, and there was no increase in analgesic requirements. "The preliminary results from the open-label portion of the phase-2b methylnaltrexone study confirm and extend the findings obtained from 14 previous clinical studies," said Robert J. Israel, M.D., Progenics' Senior Vice President, Medical Affairs. "In these very ill patients, methylnaltrexone reversed the constipation caused by opioids while not interfering with pain palliation. This study supports the potential clinical utility of methylnaltrexone to rapidly reverse a debilitating side effect of pain medication in this patient population." In Progenics' pivotal phase-3 trial, a total of 150 patients with advanced medical illness and who are receiving chronic opioids will be treated at about 25 sites nationwide. The objective of this study is to evaluate the ability of single subcutaneous doses of MNTX (0.15 mg/kg or 0.30 mg/kg) or placebo to induce laxation within four hours. Patients completing the double-blind portion of the phase-3 study are eligible to receive MNTX in a four-week open-label treatment phase. The Company also plans to expand the phase-3 program to include additional randomized, multi-dose trials of MNTX in 2003.<< snip Cheers, Tuck