Killer T Cells Against the AIDS Virus Appear to be Activated By Combination Treatment With REMUNE(TM) (Investigational HIV-1 Immunogen) and Antiviral Drugs
Data Reported at the 13th International AIDS Conference
CARLSBAD, Calif., July 13 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR - news) announced today that preliminary interim clinical results from an ongoing Phase II trial in Spain indicate that functionally active cytotoxic T lymphocytes (CTL) or ``killer'' T cells appear to be stimulated in HIV-positive individuals treated with the Company's investigational product REMUNE(TM) (HIV-1 Immunogen) in combination with antiviral drug therapy (ART). CTLs are white blood cells of the immune system that are capable of killing cells infected with HIV.
Professor Eduardo Fernandez-Cruz, M.D., Ph.D., Head of the Division of Clinical Immunology at University General Hospital ``Gregorio Maranon'' in Madrid and Principal Investigator of the Phase II trial of REMUNE in Spain presented the data in an oral presentation at the 13th International AIDS Conference in Durban, South Africa.
Dr. Fernandez-Cruz commented, ``We observed an increase of a specific subset of T cells displaying cell-surface proteins that are characteristic of effector CTLs in REMUNE-treated individuals. Importantly, this investigation has also shown that those effector CTLs are functionally active, that is to say, they have the capability to kill cells expressing HIV antigens.'' Dr. Fernandez-Cruz indicated that the CTL analysis includes a total of 23 patients and confirms earlier results indicating that REMUNE may enhance the population of memory CTLs (cells that can become effector CTLs upon re-exposure to a particular pathogen) in patients concurrently on antiviral drug therapy.
``In the patients tested thus far, we are observing CTL activity against HIV only in patients treated with REMUNE and not in the patients treated with antiviral drugs alone. These data lend support to the investigational use of REMUNE in conjunction with antiviral drugs in order to rebuild the immune system against HIV. Specifically, boosting the population of CTLs that can kill other cells infected with HIV may enable REMUNE to have a positive impact on viral load,'' said Dr. Fernandez-Cruz.
In addition, Dr. Fernandez-Cruz presented evidence that the REMUNE-induced CTLs were capable of attacking the Clade B strain of HIV. Whereas, REMUNE itself is derived from Clade A/G, an African strain of HIV, the CTLs induced by immunization with REMUNE were able to recognize and attack Clade B, the most common HIV strain in the U.S. and Europe. The same cross-strain reactive ability has also been observed for REMUNE-induced CD4 helper T cells in proliferation tests against HIV.
``These results indicate that the immune responses induced by REMUNE are directed at conserved regions of the virus, or those less likely to mutate,'' said Dr. Fernandez-Cruz. ``This is an important observation given that HIV's ability to mutate has been a key obstacle to developing effective therapeutic vaccines against HIV. The apparent ability of REMUNE to stimulate broad cross-reactive immune responses that include CTLs to several different strains of the virus suggests that REMUNE may potentially address the mutation issue and also serve as a potential universal immunogen with utility in different regions of the world where different subtypes of the virus prevail.''
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 that is designed to enable the intravenous injection of genes for delivery to the liver.
NOTE: News releases for The Immune Response Corporation are available through PR Newswire Company News On-Call fax service. For a menu of available news releases or to retrieve a specific release made by The Immune Response Corporation, please call 800-758-5804, extension 434675. Please retain these numbers for future reference. Company information can also be located on the Internet Web Site: www.imnr.com.
This news release contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including, but not limited to, whether additional clinical trials will be successfully concluded and whether REMUNE will be approved for marketing or be successfully commercialized. Those factors are discussed more thoroughly in The Immune Response Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended December 31, 1999 and subsequent forms 10-Q. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
REMUNE(TM) is a trademark of The Immune Response Corporation.
SOURCE: The Immune Response Corporation
Data Reported at the 13th International AIDS Conference
CARLSBAD, Calif., July 13 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR - news) announced today that preliminary interim clinical results from an ongoing Phase II trial in Spain indicate that functionally active cytotoxic T lymphocytes (CTL) or ``killer'' T cells appear to be stimulated in HIV-positive individuals treated with the Company's investigational product REMUNE(TM) (HIV-1 Immunogen) in combination with antiviral drug therapy (ART). CTLs are white blood cells of the immune system that are capable of killing cells infected with HIV.
Professor Eduardo Fernandez-Cruz, M.D., Ph.D., Head of the Division of Clinical Immunology at University General Hospital ``Gregorio Maranon'' in Madrid and Principal Investigator of the Phase II trial of REMUNE in Spain presented the data in an oral presentation at the 13th International AIDS Conference in Durban, South Africa.
Dr. Fernandez-Cruz commented, ``We observed an increase of a specific subset of T cells displaying cell-surface proteins that are characteristic of effector CTLs in REMUNE-treated individuals. Importantly, this investigation has also shown that those effector CTLs are functionally active, that is to say, they have the capability to kill cells expressing HIV antigens.'' Dr. Fernandez-Cruz indicated that the CTL analysis includes a total of 23 patients and confirms earlier results indicating that REMUNE may enhance the population of memory CTLs (cells that can become effector CTLs upon re-exposure to a particular pathogen) in patients concurrently on antiviral drug therapy.
``In the patients tested thus far, we are observing CTL activity against HIV only in patients treated with REMUNE and not in the patients treated with antiviral drugs alone. These data lend support to the investigational use of REMUNE in conjunction with antiviral drugs in order to rebuild the immune system against HIV. Specifically, boosting the population of CTLs that can kill other cells infected with HIV may enable REMUNE to have a positive impact on viral load,'' said Dr. Fernandez-Cruz.
In addition, Dr. Fernandez-Cruz presented evidence that the REMUNE-induced CTLs were capable of attacking the Clade B strain of HIV. Whereas, REMUNE itself is derived from Clade A/G, an African strain of HIV, the CTLs induced by immunization with REMUNE were able to recognize and attack Clade B, the most common HIV strain in the U.S. and Europe. The same cross-strain reactive ability has also been observed for REMUNE-induced CD4 helper T cells in proliferation tests against HIV.
``These results indicate that the immune responses induced by REMUNE are directed at conserved regions of the virus, or those less likely to mutate,'' said Dr. Fernandez-Cruz. ``This is an important observation given that HIV's ability to mutate has been a key obstacle to developing effective therapeutic vaccines against HIV. The apparent ability of REMUNE to stimulate broad cross-reactive immune responses that include CTLs to several different strains of the virus suggests that REMUNE may potentially address the mutation issue and also serve as a potential universal immunogen with utility in different regions of the world where different subtypes of the virus prevail.''
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 that is designed to enable the intravenous injection of genes for delivery to the liver.
NOTE: News releases for The Immune Response Corporation are available through PR Newswire Company News On-Call fax service. For a menu of available news releases or to retrieve a specific release made by The Immune Response Corporation, please call 800-758-5804, extension 434675. Please retain these numbers for future reference. Company information can also be located on the Internet Web Site: www.imnr.com.
This news release contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including, but not limited to, whether additional clinical trials will be successfully concluded and whether REMUNE will be approved for marketing or be successfully commercialized. Those factors are discussed more thoroughly in The Immune Response Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended December 31, 1999 and subsequent forms 10-Q. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
REMUNE(TM) is a trademark of The Immune Response Corporation.
SOURCE: The Immune Response Corporation
