Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - Tuesday November 28, 2000
The goal of the newly initiated Phase II trial is to define the dose and frequency of administration of PRO 542. In the study, HIV-infected children will be treated with weekly doses of PRO 542 and monitored for safety, blood levels of PRO 542 and plasma HIV RNA or "viral load," a widely accepted endpoint for antiretroviral therapies. The trial is sponsored by the Pediatric AIDS Clinical Trials Group (PACTG) of the National Institutes of Health.
In the initial pediatric trial of PRO 542, as described in The Journal of Infectious Diseases, both single and multiple doses of PRO 542 were well tolerated, and consistent blood levels of PRO 542 were achieved upon repeat dosing. All children who received multiple doses of PRO 542 experienced decreases in HIV RNA that ranged up to 1.5 log(10) and that often persisted for as long as 14 days post treatment.
"The growing incidence of multidrug-resistant viruses mandates the search for new and less toxic therapies," said William T. Shearer, M.D., Ph.D., Professor, Baylor College of Medicine and Texas Children's Hospital (Houston, TX), lead author of the report and Principal Investigator of the pediatric studies. "The encouraging clinical results which we reported in the publication provide strong support for the potential role of PRO 542 in the treatment of HIV patients, and the PACTG is pleased to initiate expanded clinical trials for this promising new agent."
"The initiation of this Phase II study is an important milestone in the development of PRO 542," said Ronald J. Prentki, President of Progenics. "Our program for PRO 542 has advanced on many fronts, including recent announcements on in vitro synergy when used in combination with other viral entry inhibitors as well as promising initial clinical data in both HIV-infected adults and children. This study is the first of several Phase II trials which we anticipate will lead the way to more advanced studies."
Recently, Progenics reported that the triple combination of PRO 542, PRO 140 (a monoclonal antibody to the CCR5 fusion coreceptor being developed by Progenics) and T-20 (an experimental HIV fusion inhibitor being developed by Trimeris, Inc. and F. Hoffmann-La Roche Ltd) demonstrated significantly enhanced or synergistic activity in blocking HIV entry into cells. In addition, Progenics recently reported the structure of PRO 542 in complex with the HIV envelope glycoprotein gp120 as determined by electron microscopy. This detailed molecular picture revealed that PRO 542 possesses exceptional structural flexibility. As a result, PRO 542 may be uniquely able to neutralize HIV by cross-linking as many as four gp120s on the surface of one or more virus particles. In an animal model of HIV infection, PRO 542 prevented infection by viruses isolated from HIV-infected individuals. In other preclinical studies, PRO 542 was shown to potently neutralize HIV strains from all geographic regions. Progenics has a collaboration with Genzyme Transgenics Corporation to develop transgenic animals for cost-effective production of PRO 542.
Progenics Pharmaceuticals, Inc. is a biopharmaceutical company focusing on the development and commercialization of products for the treatment and prevention of cancer, viral and other life-threatening diseases. The Company's lead HIV product, PRO 542, has completed two Phase I/II clinical trials, and two follow-on HIV products, PRO 367 and PRO 140, are preparing to commence Phase I/II trials. Progenics also has collaborations with F. Hoffmann-La Roche Ltd in the area of HIV fusion co-receptors, and with American Home Products and Pharmacopeia, Inc. focusing on HIV attachment and fusion. The Company's most advanced product, GMK, is a cancer vaccine in pivotal Phase III clinical trials for the treatment of malignant melanoma. The company is also prepared to commence Phase II trials with a second cancer vaccine, MGV, with broad application to a variety of cancers. GMK and MGV are the subject of a collaboration with Bristol-Myers Squibb Company. The Company, with Cytogen Corporation, has formed a joint venture focusing on the development of cancer immunotherapies based on PSMA (Prostate Specific Membrane Antigen) technology.
The Company is also developing a novel small-molecule antioxidant, DHA, to treat stroke and other disorders.
This press release contains forward-looking statements. Any statements contained herein that are not statements of historical fact may be forward-looking statements. When Progenics uses the words "anticipates," "plans," "expects" and similar expressions, the Company is identifying forward-looking statements. Such forward-looking statements involve risks and uncertainties which may cause Progenics' 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 when or proceed as planned, the risks and uncertainties associated with dependence upon the actions of the Company's corporate, academic and other collaborators and of government regulatory agencies, the risk that products that appeared promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the uncertainty of future profitability and other factors set forth more fully in Progenics' Annual Report on Form 10-K for the fiscal year ended December 31, 1999 and other periodic filings with the Securities and Exchange Commission. In particular, Progenics cannot assure you that any of the Company's programs will result in a commercial product. Progenics does not have a policy of updating or revising forward-looking statements, and 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.
Contact: Ronald J. Prentki, President of Progenics Pharmaceuticals, Inc., 914-789-2800, rprentki@progenics.com; or Renee Connolly, Media of Noonan-Russo Communications, Inc., 212-696-4455, ext. 227, renee@noonanrusso.com
SOURCE: Progenics Pharmaceuticals, Inc.
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