EX-99.1 2 a4736357ex99.txt EXHIBIT 99.1 PRESS RELEASE Exhibit 99.1 Progenics Announces Achievement of Enrollment Target in Phase 2 Clinical Trial of Methylnaltrexone for Post-Operative Ileus TARRYTOWN, N.Y.--(BUSINESS WIRE)--Oct. 7, 2004--Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) 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. Company Profile 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. The Company has five product candidates in clinical development and several others in preclinical development. In symptom management and supportive care, the Company is developing methylnaltrexone (MNTX) to treat the debilitating side effects of opioid-based pain relievers without interfering with pain relief. MNTX is in pivotal phase 3 clinical testing for treatment of opioid-induced constipation in patients with advanced medical illness and may be the Company's first product candidate to be approved for marketing. MNTX is also being studied for the treatment of post-operative ileus and relief of opioid-induced constipation in patients with chronic pain. In the area of HIV infection, the Company is developing viral-entry inhibitors, including PRO 542, a genetically engineered molecule designed to selectively target and neutralize HIV (in phase 2 studies), and PRO 140, a monoclonal antibody designed to target the HIV coreceptor CCR5 (in phase 1 studies). In addition, the Company is conducting research on ProVax, a novel prophylactic HIV vaccine. The Company, in collaboration with Cytogen Corporation, is developing immunotherapies for prostate cancer, including monoclonal antibodies directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. The Company 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 studying a cancer vaccine, GMK, in phase 3 clinical trials for the treatment of malignant melanoma. DISCLOSURE NOTICE: The information contained in this document is current as of October 7, 2004. 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, 2003 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 is available at http://www.progenics.com CONTACT: Progenics Pharmaceuticals, Inc. Richard W. Krawiec, Ph.D., 914-789-2800 rkrawiec@progenics.com