MADISON, N.J. and TARRYTOWN, N.Y., Dec. 20 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , and Progenics Pharmaceuticals, Inc. today announced the initiation of the second of two global, pivotal phase 3 clinical trials to evaluate the safety and efficacy of intravenous methylnaltrexone for the treatment of post-operative ileus (POI). The first phase 3 trial was initiated in September 2006.
POI is a temporary impairment of gastrointestinal (GI) function characterized by abdominal bloating and pain, nausea and vomiting, and an inability to pass gas or a stool. POI is a common response to abdominal surgical procedures, but can also occur after other types of surgery. POI can worsen when opioid analgesics, such as morphine, are given to relieve post-operative pain, potentially leading to delayed introduction of food, lengthened hospital stays and increased health care costs.
Millions of surgical procedures are performed each year in the United States, most requiring opioid pain management. Methylnaltrexone is a mu-opioid receptor antagonist designed to reverse the peripheral side effects caused by opioids, particularly in the GI tract. It does not interfere with brain- centered pain relief. In a pilot phase 2 clinical trial previously conducted by Progenics, patients who received methylnaltrexone following segmental colectomy exhibited improvements in clinically important measures of GI recovery, including time to first bowel movement and discharge eligibility from the hospital. Methylnaltrexone was generally well tolerated in this study, with no reports of serious adverse events related to the drug. The most frequent adverse events were fever and nausea, with frequencies comparable in both groups.
Similar to the first phase 3 POI trial, the second study will enroll approximately 500 patients who have undergone segmental colectomy surgery in a double-blind, randomized, placebo-controlled clinical trial at approximately 75-90 surgical centers worldwide. Key elements of the study design, including the primary efficacy end point, were reviewed with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment in July 2006. In this trial, study medication (methylnaltrexone, at one of two dose levels, or placebo) will be administered following surgery and every six hours thereafter until the patient recovers GI function, or for up to 10 days after surgery. The primary efficacy end point is duration of POI as measured by time to first bowel movement. The study will also examine safety and other secondary measures of GI recovery, including time to discharge eligibility. Additional details regarding the clinical trial will be available at http://www.clinicaltrials.gov.
The intravenous form of methylnaltrexone currently under investigation for the treatment of POI received Fast Track designation from the FDA in July 2006. Fast Track designation facilitates development and may expedite regulatory review of drugs that the FDA recognizes as potentially addressing an unmet medical need for serious or life-threatening conditions. Subsequent to satisfactory completion of these studies, a New Drug Application is planned for intravenous methylnaltrexone in late 2007 or early 2008.
Because many postoperative patients cannot tolerate oral medications, intravenous methylnaltrexone may represent an important therapeutic option. Methylnaltrexone is also being developed in other dosage forms, including subcutaneous and oral forms, as treatment for opioid-induced constipation.
About the Companies
Wyeth Pharmaceuticals has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
WYETH DISCLOSURE NOTICE: The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third party-payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "ITEM 1A, RISK FACTORS." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
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 conditions and life-threatening diseases. Principal programs are directed toward symptom management and supportive care and the treatment of HIV 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 ileus. In the area of HIV infection, the Company is developing the viral-entry inhibitor, PRO 140, a humanized monoclonal antibody targeting the HIV coreceptor CCR5 (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-drug conjugate directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. Progenics is also developing vaccines designed to stimulate an immune response to PSMA, and has a recombinant PSMA vaccine in phase 1 clinical testing. The Company is also developing a cancer vaccine, GMK, in phase 3 clinical trials for the treatment of malignant melanoma.
PROGENICS DISCLOSURE NOTICE: The information contained in this document is current as of December 20, 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.
Additional information on Progenics available at http://www.progenics.com
Additional information on Wyeth available at http://www.wyeth.com