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Progenics (PRO 140) Announces Progress and Presentations in HIV Therapy Program
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-- Enrollment for PRO 140 phase 2 clinical
studies completed --
-- Interim phase 2 results for intravenous
form of PRO 140 to be presented at 'late-breaker'
ICAAC session --
-- PRO 140 phase 1b clinical study
results published in Journal of Infectious Diseases --
"PRO140 is a humanized monoclonal antibody that binds to CCR5, a co-receptor characterized by Progenics and its collaborators in 1996 as the principal molecular portal used by HIV to enter and infect immune system cells. In February 2006, PRO140 was designated a Fast Track product by FDA for the treatment of HIV infection."
TARRYTOWN, N.Y., Oct 02, 2008 -- Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the completion of enrollment in two, phase 2 clinical studies of PRO 140, an investigational drug that is being developed for treatment of human immunodeficiency virus (HIV) infection. The phase 2 studies are separately evaluating intravenous and subcutaneous forms of PRO 140. The Company also reported that interim antiviral and tolerability data from the phase 2 study of intravenous PRO 140 have been selected for presentation in a "late-breaker" session at the joint meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases Society of America (IDSA) to be held October 25-28, 2008 in Washington, D.C. Finally, the Company announced the online publication of results from a phase 1b study, authored by Progenics' scientists and their academic collaborators, of intravenous PRO 140 in the Journal of Infectious Diseases, a peer-reviewed science journal.
"Despite recent progress, treatment of HIV infection remains challenged by viral resistance, daily adherence, drug toxicities, and our growing recognition of the widespread bodily damage caused by uncontrolled HIV replication," said Jeffrey M. Jacobson, M.D., Professor of Medicine, Microbiology, and Immunology, and Chief, Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine, and lead author of the Journal of Infectious Diseases article. "Continued advances will require a robust pipeline of new HIV drugs to address these therapeutic shortcomings. PRO 140 could offer a new approach to HIV therapy for patients with CCR5-tropic virus at various stages of their disease, in light of the extended antiviral activity, favorable tolerability and barrier to resistance exhibited by PRO 140 to date."
PRO 140 is a humanized monoclonal antibody directed against CCR5, the principal portal used by HIV to enter and infect immune system cells. As a viral-entry inhibitor, PRO 140 is designed to treat HIV by protecting healthy cells from infection.
Enrollment completed in two, phase 2 studies
The Company also announced the completion of enrollment of two phase 2 clinical studies which were initiated in January 2008. The double-blind, placebo-controlled trials are being conducted in individuals with early-stage HIV disease and who have not received antiretroviral therapy in the previous three months. Prior to treatment, all patients were screened for the presence of virus that uses CCR5, and the absence of virus that uses CXCR4, as the entry co-receptor. Patients are being monitored for approximately two months to assess tolerability, antiviral activity and blood concentrations of PRO 140. Additional information on the phase 2 trials is available at www.clinicaltrials.gov.
"The timely enrollment of the phase 2 studies reflects our dedication to furthering the clinical development of PRO 140, and the high degree of enthusiasm among HIV physicians for PRO 140," said Paul J. Maddon, M.D., Ph.D., Chief Executive Officer, Chief Science Officer and Founder of Progenics. "We look forward to sharing interim results from the phase 2 study of intravenous PRO 140 at the ICAAC/IDSA joint meeting. The complete data set from both phase 2 studies should provide information to help us design a registration program. We expect to present the full analysis of these studies at future scientific conferences and also plan to meet with the U.S. Food and Drug Administration to assess next steps for initiating pivotal studies."
The phase 2 trial of intravenous PRO 140 enrolled 31 individuals who were randomized to receive a single dose of placebo, 5 mg/kg PRO 140 or 10 mg/kg PRO 140. Interim data from this trial will be presented at the upcoming ICAAC/IDSA meeting.
The second phase 2 trial is evaluating subcutaneous PRO 140 administered as three weekly doses or two bi-weekly (once every two weeks) doses. This study is being conducted in 44 individuals randomized to receive placebo, 162 mg PRO 140 weekly, 324 mg PRO 140 weekly, or 324 mg PRO 140 bi-weekly. Subcutaneous PRO 140 is being developed as a potential long-acting, self-administered therapy for HIV infection. Progenics expects to report phase 2 data for subcutaneous PRO 140 in early 2009.
New PRO 140 phase 2 results to be presented as 'late-breaker' at scientific conference
The ICAAC/IDSA poster presentation will provide interim phase 2 data for intravenous PRO 140 and will be the first reported phase 2 clinical data for the investigational drug. Progenics is scheduled to present these data as follows:
Sunday, October 26, 2008, 11:15 a.m. - 12:15 p.m. ET
Session title: Antiretroviral Therapy: New Agents
Poster number: H-1269a
"Antiviral Activity and Tolerability of 5 mg/kg and 10 mg/kg
Doses of PRO 140, a Humanized Monoclonal Antibody to CCR5"
Published PRO 140 phase 1b results
The Journal of Infectious Diseases publication provides the first detailed analysis of the phase 1b clinical trial of PRO 140. The online article can be accessed via the home page of Progenics' website, www.progenics.com, or directly at: http://delivery.sheridan.com/index.php?ID=UCP_142660_EP. The print article will appear in the November 1, 2008 edition of the journal. Preliminary results from the phase 1b study were first presented in July 2007 at a plenary session of the International AIDS Society meeting in Sydney, Australia. Results were also presented at ICAAC in September 2007.
In the published study, all patients treated with 5 mg/kg PRO 140 experienced a greater than 10-fold reduction in viral load. PRO 140 was generally well tolerated, and no dose-limiting toxicity was observed. This first clinical study of PRO 140 in HIV-infected individuals established clear proof of concept for this monoclonal antibody as a potent antiretroviral agent with extended activity after a single dose.
About PRO140
Discovered by Progenics' scientists, PRO140 is a humanized monoclonal antibody that binds to CCR5, a co-receptor characterized by Progenics and its collaborators in 1996 as the principal molecular portal used by HIV to enter and infect immune system cells. Some strains of HIV use the CXCR4 co-receptor as a portal of entry either exclusively or alternatively to CCR5. Unlike small-molecule CCR5 antagonists, PRO140 inhibits HIV entry at concentrations that in vitro do not appear to block CCR5's natural activity of directing the migration of immune cells towards sites of inflammation in the body. As a monoclonal antibody, PRO140 is not metabolized by the liver, and therefore may have the potential for a better tolerability profile than many of the existing small-molecule therapies for HIV-1 infection. In February 2006, PRO140 was designated a Fast Track product by FDA for the treatment of HIV infection.
Progenics gratefully acknowledges the development funding it has received for PRO140 from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (1 U19 AI066329).
(PGNX-C)
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, virology--including human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections--and oncology. Progenics, in collaboration with Wyeth, is developing RELISTOR(TM) (methylnaltrexone bromide) for the treatment of opioid-induced side effects. In the U.S., RELISTOR (methylnaltrexone bromide) subcutaneous injection is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. In Canada, RELISTOR (methylnaltrexone bromide injection) for subcutaneous use is indicated for the treatment of OIC in patients with advanced illness receiving palliative care. In European member states and Iceland, Norway and Liechtenstein, RELISTOR (methylnaltrexone bromide) subcutaneous injection is indicated for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to the usual laxative therapy has not been sufficient. Marketing applications are pending for RELISTOR in Australia and other countries. In the area of virology, Progenics is developing the HIV entry inhibitor PRO 140, a humanized monoclonal antibody targeting the entry co-receptor CCR5, which is in phase 2 clinical testing. Pre-clinical programs for the development of novel HCV entry inhibitors are also underway. In the area of oncology, the Company is conducting a phase 1 clinical trial of a human monoclonal antibody-drug conjugate (ADC) for the treatment of prostate cancer--a selectively targeted cytotoxic antibody directed against prostate-specific membrane antigen (PSMA). PSMA is a protein found on the surface of prostate cancer cells as well as in blood vessels supplying other solid tumors. Progenics is also developing vaccines designed to treat prostate cancer by stimulating an immune response to PSMA.
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