Progenics Selected to Present Clinical Results for Novel HIV Therapy PRO 140 at International Aids Conference
IAS plans to webcast live late-breaker-session presentations, which will then be archived. Progenics' presentation can be accessed through the IAS website at: http://www.ias2007.org/pag/PSession.aspx?s=151.
Separately, Progenics announced that it has been selected for an oral presentation of the PRO 140 phase 1b clinical trial results at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago. Additional results from this study will be presented in a plenary session on Tuesday, September 18, 2007 at 8:30 a.m., Central Daylight Time (9:30 a.m., Eastern Daylight Time).
In May 2007, Progenics announced positive top-line results from this phase 1b study, the first clinical trial of PRO 140 in HIV-infected individuals. These results showed average maximum viral load reductions of 98.5% (1.83 log10), and that PRO 140 was generally well tolerated in the study. The phase 1b trial established proof of concept for PRO 140 as a potent antiretroviral agent with extended activity following a single dose.
About PRO 140
PRO 140 is a humanized monoclonal antibody discovered by Progenics' scientists that binds CCR5 on immune system cells and shields the cells from HIV infection. CCR5 is a receptor for chemokines, members of a family of molecules that direct the migration of immune cells towards sites of inflammation in the body. Progenics and its collaborators discovered the role of CCR5 in HIV infection in 1996.
In laboratory studies, PRO 140 has demonstrated potent, broad-spectrum antiviral activity against approximately 100 genetically diverse HIV strains, isolated directly from infected individuals, which use the CCR5 receptor. In these preclinical models, PRO 140 was shown to protect both primary T-cells and macrophages, immune system cells that provide the major targets for HIV infection in vivo. In the laboratory, PRO 140 has shown synergistic activity when combined with small-molecule CCR5 antagonists in development. Importantly, in vitro testing also demonstrated that PRO 140 inhibited viruses that were resistant to small-molecule CCR5 antagonists. Unlike other CCR5 entry inhibitors currently in development, PRO 140 inhibits HIV entry at concentrations that do not block the natural activity of CCR5 in vitro.
PRO 140 has been designated Fast Track status by the United States Food and Drug Administration (FDA) for the treatment of HIV infection. The FDA Fast Track Development Program facilitates development and expedites regulatory review of drugs intended to address an unmet medical need for serious or life-threatening conditions. With Fast Track designation for PRO 140, Progenics can take advantage of several programs at FDA to streamline the regulatory review process and to work more closely with FDA on product development plans.
(PGNX-G)
About The Company
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 gastroenterology as well as 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 bowel dysfunction. In March 2007, the Company submitted a New Drug Application to the United States Food and Drug Administration for the subcutaneous formulation of methylnaltrexone for patients suffering from opioid-induced constipation while receiving palliative care. In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV co-receptor CCR5, which has completed phase 1b clinical studies with positive results. 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), a protein found on the surface of prostate cancer cells. Progenics is developing vaccines designed to stimulate an immune response to PSMA and has a recombinant PSMA vaccine is 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 July 12, 2007. 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, 2006, 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
Contact
Investors:
Progenics Pharmaceuticals, Inc.
Richard W. Krawiec, Ph.D., 914-789-2814
Vice President
Corporate Affairs
rkrawiec@progenics.com
or
Media:
WeissComm Partners
Barri Winiarski, 917-584-7468
Posted: July 2007
