Printer Friendly
The Free Library
14,505,492 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Positive Results from Phase 3 Clinical Study of Methylnaltrexone Treatment for Opioid-Induced Constipation Presented at Digestive Disease Week Conference.


LOS ANGELES -- Progenics Pharmaceuticals, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE NYSE

See: New York Stock Exchange
: WYE), announced that a late-breaking oral presentation of phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study.  results for methylnaltrexone was made today at the Digestive Disease Week (DDW DDW Digestive Disease Week
DDW Diseases of the Developing World
DDW Dimensional Data Warehouse
DDW Digital Data Warfare
DDW Darkness Does Wonders (bar slang)
DDW Data Driven Workflow
) conference in Los Angeles, CA.

The results are from the second pivotal phase 3 clinical trial of the subcutaneous form of the investigational drug methylnaltrexone for the treatment of opioid-induced constipation in patients with advanced illnesses, such as cancer and cardiovascular disease Cardiovascular disease
Disease that affects the heart and blood vessels.

Mentioned in: Lipoproteins Test

cardiovascular disease 
. Results presented at DDW showed that nearly half of constipated con·sti·pat·ed
adj.
Suffering from constipation.
 patients with advanced illness experienced laxation (bowel movement) within four hours of receiving their first dose of methylnaltrexone (0.15 mg/kg), and more than 70% responded by the end of the first week of treatment (0.15 mg/kg qod). For those who responded, the median time to laxation following methylnaltrexone treatment was 30 minutes, and there were no reports of diminished analgesia analgesia /an·al·ge·sia/ (an?al-je´ze-ah)
1. absence of sensibility to pain.

2. the relief of pain without loss of consciousness.
 due to study medication.

"In order to provide the most compassionate care possible, health care professionals want to focus on aggressive pain management without the worry of opioid-induced bowel dysfunction," says study investigator Neil Slatkin, M.D., DABPN, Director, Department of Supportive Care supportive care,
n medical and other interventions that attempt to support and make comfortable rather than to cure.
, Pain and Palliative Medicine, City of Hope, Duarte, CA. "These data are encouraging for patients living with advanced illnesses who must take opioids to control their pain."

Opioids such as morphine are widely used to lessen the suffering of the approximately 1.7 million Americans living with painful terminal illnesses. In addition to their analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs  effect of blocking the perception of pain within the central nervous system, these medications also interact with opioid-specific receptors outside the brain and spinal cord spinal cord, the part of the nervous system occupying the hollow interior (vertebral canal) of the series of vertebrae that form the spinal column, technically known as the vertebral column. , resulting in constipation. More than 50 percent of cancer patients admitted to palliative care palliative care (paˑ·lē·ā·tiv kerˑ),
n an approach to health care that is concerned primarily with attending to physical and emotional comfort rather
 units experience opioid-induced bowel dysfunction. Opioid-induced bowel dysfunction includes constipation that is not adequately addressed by current therapies, such as laxatives Laxatives Definition

Laxatives are products that promote bowel movements.
Purpose

Laxatives are used to treat constipation—the passage of small amounts of hard, dry stools, usually fewer than three times a week.
 or stool softeners. Methylnaltrexone is a peripheral opioid-receptor antagonist designed to rapidly block the effect of these medications on opioid receptors Opioid receptors
Receptors located in the brain and various organs that bind opiates or opioid substances.

Mentioned in: Methadone

opioid receptors,
n.pl any of the several receptors to which opiates bind.
 outside the central nervous system. Since methylnaltrexone does not cross the blood-brain barrier, it does not interfere with brain-centered pain relief.

Study Design

In the double blind, placebo-controlled trial, 133 patients with advanced illness at nursing homes, hospice and palliative care centers across the U.S. were randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 to receive either methylnaltrexone (0.15 mg/kg, SC) or placebo every other day for two weeks. All patients experienced opioid-induced constipation, despite the use of laxatives and stool softeners. No rescue laxatives were allowed within four hours of dosing. By day eight, a blinded dose escalation was permitted (methylnaltrexone, 0.30 mg/kg or placebo) if a patient did not have at least three bowel movements during the previous week that were not associated with rescue therapy. This dosing regimen was continued through the remaining week of the trial (dosing on days 9, 11 and 13). Co-primary endpoints were laxation within four hours of the first dose and laxations occurring within four hours of at least two of the first four doses.

Top-line Results

--48.4% of patients experienced laxation within 4 hours of receiving the first dose of methylnaltrexone (0.15 mg/kg), more than three times the rate seen in patients treated with placebo (15.5%) (p less than 0.0001).

--51.6% of patients experienced laxation within four hours of receiving at least two of the first four doses, compared to 8.5% receiving placebo (p less than 0.0001).

--The most frequently reported adverse event was transient abdominal cramping.

Progenics-Wyeth Collaboration

In December 2005, Wyeth and Progenics entered into a license and co-development agreement for the development and commercialization of methylnaltrexone. Under the terms of the collaboration, Wyeth will develop oral methylnaltrexone worldwide. Progenics will lead the U.S. development of subcutaneous and intravenous methylnaltrexone, while Wyeth will lead development for these formulations outside of the U.S. In 2006, phase 3 clinical studies are set to begin in the U.S. and Europe for post-operative bowel dysfunction with intravenous methylnaltrexone, and the oral product will enter phase 2 in patients receiving opioids for chronic pain.

(PGNX-C)

About Progenics

Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 conditions and life-threatening diseases. Principal programs are directed toward symptom management and supportive care and the treatment of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  infection and cancer. The Company has four product candidates in clinical development and several others in preclinical development. The Company, in collaboration with Wyeth, is developing methylnaltrexone for the treatment of opioid-induced side effects, including constipation and post-operative bowel dysfunction. In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV coreceptor CCR 1. CCR - condition code register.
2. CCR - (Database) concurrency control and recovery.
5 (in phase 1b studies). In addition, the Company is conducting research on ProVax, a novel prophylactic HIV vaccine. The Company is developing in vivo immunotherapies for prostate cancer, including a human monoclonal antibody directed against prostate-specific membrane antigen (PSMA PSMA Public Sector Mapping Agencies (Australia)
PSMA Prostate-Specific Membrane Antigen
PSMA Power Sources Manufacturers Association
PSMA Pakistan Sugar Mills Association
PSMA Professional Services Management Association
), a protein found on the surface of prostate cancer cells. Progenics is also developing vaccines designed to stimulate an immune response to PSMA. A recombinant PSMA vaccine is in phase 1 clinical testing. The Company is also developing a cancer vaccine, GMK GMK Grand Master Key (locksmithing)
GMK Gnu Make File
, in phase 3 clinical trials for the treatment of malignant melanoma.

PROGENICS DISCLOSURE NOTICE: The information contained in this document is current as of May 23, 2006. This press release contains forward-looking statements. Any statements contained herein that are not statements of historical fact may be forward-looking statements. When the Company uses the words "anticipates"' "plans"' "expects" and similar expressions, it is identifying forward-looking statements. Such forward-looking statements involve risks and uncertainties which may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. Such factors include, among others, the uncertainties associated with product development, the risk that clinical trials will not commence or proceed as planned, the risks and uncertainties associated with dependence upon the actions of our corporate, academic and other collaborators and of government regulatory agencies, the risk that our licenses to intellectual property may be terminated because of our failure to have satisfied performance milestones, the risk that products that appear promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that we may not be able to manufacture commercial quantities of our products, the uncertainty of future profitability and other factors set forth more fully in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and other reports filed with the Securities and Exchange Commission, to which investors are referred for further information. In particular, the Company cannot assure you that any of its programs will result in a commercial product.

Progenics does not have a policy of updating or revising forward-looking statements and assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments. Thus, it should not be assumed that the Company's silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements.

Editor's Note:

Additional information on Progenics available at http://www.progenics.com.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:May 23, 2006
Words:1212
Previous Article:ANA Moving to Customer-Centric Unisys Airline Solution to Streamline Passenger Operations; Leading Japanese Airline Chooses Unisys AirCore to Replace...
Next Article:Avocent Announces Divisional Realignment.
Topics:



Related Articles
ENZO BIOCHEM TREATMENT ALLEVIATES TRANSPLANTATION SIDE EFFECTS.
Incidence of constipation associated with long-acting opioid therapy: a comparative study.(Original Article)
Progenics Pharmaceuticals Initiates Clinical Trial of Viral-Entry Inhibitor PRO 140 in HIV-Infected Patients; Monoclonal Antibody Designed to Block...
GlaxoSmithKline and Adolor Announce the Completion of Enrollment of Pivotal Clinical Studies of Entereg(R) (Alvimopan).
GlaxoSmithKline and Adolor Present Positive Results from a Clinical Study of Alvimopan (Entereg(R)).
Progenics Achieves Enrollment Target in Clinical Trial of HIV Entry Inhibitor PRO 140.
Somaxon Pharmaceuticals to Announce Results of Phase 3 Clinical Trial of SILENOR(TM) for the Treatment of Insomnia in Elderly Patients and Host...
Opioids for chronic nonterminal pain.
Cougar Biotechnology Presents Positive CB7630 Clinical Data at AACR Annual Meeting Late-Breaking Clinical Trials Session.
Progenics Announces Positive Results in Clinical Trial of Novel HIV Therapy.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles