Remune Development Stopped
Below are two news releases from Agouron reporting disappointing results from a Spanish study of 243 treatment naive patients receiving HAART + Remune or HAART. The second more recent news release announces an orderly transition in stopping development of Remune.
The Immune Response Corporation Reports
Findings From Phase II Clinical Trial of REMUNE in HIV-Infected Patients
Business Wire via Dow Jones
CARLSBAD, Calif.--(BUSINESS WIRE)--June 1, 2001--The Immune Response Corporation (NASDAQ:IMNR) announced today that an independent Data Safety Monitoring Board (DSMB) has evaluated the results from a phase II clinical trial (STIR 2102) completed in Spain with REMUNE(TM) (HIV-1 Immunogen), an investigational immune-based therapy.
The results indicated that the study did not meet the primary endpoint (i.e. time to increase to 5,000 copies/ml of viral load -- the amount of HIV detected in the blood -- or a 50% decrease in CD4+ T cells/ml or a decrease to less than 250 CD4+ T cells/ml while on antiretroviral therapy (ART)). The primary endpoint analysis revealed no significant difference between the control group 41% (50/121) and the REMUNE group 30% (35/118) p=0.20.
The DSMB also noted however, that their study included a subgroup analysis that seemed to indicate that REMUNE may have had a positive effect on viral load in patients that are more immunocompetent. The DSMB recommended further studies with REMUNE in such patients.
Results from this trial will be presented by the principal investigator, Professor Eduardo Fernandez-Cruz, M.D., Ph.D., on June 25, 2001, at the Sixth European Conference on Experimental AIDS Research in Edinburgh, Scotland. Professor Fernandez-Cruz is Head of the Department of Clinical Immunology at the University General Hospital "Gregorio Maranon" in Madrid, Spain.
"The treatment of HIV infection is remarkably complex and there is an increasing need for new immune based therapies. The results of this trial may have identified the patient population that is potentially immunologically capable of responding to an immune based therapy in which therapeutic vaccination with REMUNE may exert a positive impact on viral load," said Fernandez-Cruz.
The study conducted in Spain was a multicenter, double-blind, placebo-controlled, randomized trial of 243 antiviral naive patients with chronic HIV infection with CD4+ T cells between 300-700 cells/ml. Viral load measured at study entry ranged in this population from less than 10,000 copies/ml to greater than 100,000 copies/ml. The efficacy of REMUNE, administered in combination with antiretroviral therapy (ART), was assessed by comparing the time to increases in viral load and decreases in CD4 T cell counts between patient groups that received ART plus REMUNE or ART plus placebo. The trial was conducted at 13 major clinical centers throughout Spain.
REMUNE, an HIV-specific immune-based therapy under development, is a special preparation of modified, killed HIV that is designed to stimulate T cells to produce an immune response to HIV-specific antigen. It is hoped that this enhanced immune response will help to control infection and consequently slow the progression to AIDS. REMUNE is the subject of investigation in several clinical trials including a trial sponsored by Agouron Pharmaceuticals, Inc. and The Immune Response Corporation. The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, developing immune-based therapies to induce specific T-cell responses for the treatment of HIV, autoimmune diseases and cancer. In addition, the Company is developing a targeted non-viral delivery technology for gene therapy, which is designed to enable the delivery of genes directly to the liver via intravenous injection.
Agouron Pharmaceuticals, Inc. Terminates REMUNE(TM) Development Collaboration
CARLSBAD, Calif., July 6 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR) announced today it has received notification of the termination by Agouron Pharmaceuticals, Inc. (a Pfizer company) of the continued development and commercialization of REMUNE(TM) (HIV-1 Immunogen), an investigational immune-based therapy for the treatment of individuals infected with HIV. The Company will regain full rights in the U.S., Europe, Japan and certain other countries to REMUNE as a result of Agouron's decision to end the collaboration. Agouron has advised that it will cooperate with the Company to effect an orderly transition of Agouron's development responsibilities to the Company.
The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, developing immune-based therapies to induce specific T-cell responses for the treatment of HIV, autoimmune diseases and cancer. In addition, the Company is developing a targeted non-viral delivery technology for gene therapy, which is designed to enable the delivery of genes directly to the liver via intravenous injection.