Immune Response -> Mittel gegen AIDS gefunden? - 500 Beiträge pro Seite

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Immune Response Corp. (IMNR) rose as high as $3.05 in early Nasdaq trading. It closed at $1.63 Friday. The drug-development company said in a press release distributed by PR Newswire its Remune HIV therapy reduces the virus in the bloodstream at a statistically significant level. The drug outperformed a placebo and generated immune responses that ``correlate with control of the virus.`` Company officials weren`t immediately available for comment.

quelle: www.bloomberg.com

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micky

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Hier die ganze News:

IMNR
2.97
+1.34



Monday April 23, 7:00 am Eastern Time
Press Release
SOURCE: The Immune Response Corporation
The Immune Response Corporation Announces Publication of Study Suggesting That REMUNE(TM) Induces HIV-1 Specific T Helper Immune Responses That Correlate With Control of Virus
CARLSBAD, Calif., April 23 /PRNewswire Interactive News Release/ -- The Immune Response Corporation (Nasdaq: IMNR - news) announced the publication of data today that suggest REMUNE(TM) (HIV-1 Immunogen), an investigational immune-based therapy, induces HIV specific (T helper cells) immune responses that correlate with control of virus (viral load, the amount of HIV in the bloodstream) in HIV-positive individuals. An analysis of a protocol defined random cohort from a Phase 3 study showed that patients treated with REMUNE demonstrated a statistically significant reduction in viral load at multiple time points throughout the trial, regardless of concomitant antiretroviral drug therapy. The results of the study appear in the April edition of HIV Medicine (www.BlackwellScientific.com), the official Journal of the European AIDS Clinical Society and the British HIV Association.

The protocol defined random cohort involved 252 HIV-positive individuals who received injections of either REMUNE or a placebo (Incomplete Freund`s Adjuvant) in addition to un-restricted anti-retroviral drug use. A 2500-patient, multi-center, double-blind, adjuvant-controlled, clinical endpoint Phase 3 study begun in 1996 included this cohort study that was designed to determine the relationship between viral load (amount of virus in the blood) and HIV-specific immunity.

Viral load was measured as HIV-1 plasma RNA levels every 12 weeks, more frequently than in other patients in the larger study (whose viral load was measured every 24 weeks). In the REMUNE treated group, a significantly greater decline in viral load (p<0.05) at multiple time points was observed. These differences in viral load were not significant for the first two time-points but were observed at week 36 (p=0.01), and were maintained at weeks 48 (p=0.02), 60 (p=0.02), 84 (p=0.001), 96 (p=0.004), and 120 (p=0.03). The authors believe that the apparent 36-week ``lag time`` between the initial treatment with REMUNE and a significant reduction in viral load may suggest that the immune system requires a period of time after immunization to organize specific immune forces against the virus. Lymphocyte Proliferation Assays (LPAs) were also performed on blood samples taken every 24 weeks. LPAs are a common measure of the ability of the immune system to respond to HIV via T helper cells. LPA test results indicated that HIV-specific T helper cell immune responses were generated only in the REMUNE treated group (p<0.0001). In the REMUNE treated group, LPA to HIV antigens after immunization (24 weeks) correlated with the amount of virus in the blood (week 24, r=-0.32, p=0.002; week 48, r=-0.42, p=0.001; week 72, r=-0.29, p=0.05; week 96, r=-0.35, p=0.003; week 120, r=-0.53, p=0.001).

``Since many of these patients were taking potent antiretroviral drugs and were permitted to switch drugs ad lib, we expected to see a decrease in viral load in both the placebo group and the REMUNE group,`` said John Turner, M.D., of the Graduate Hospital (Philadelphia, PA) and principal author of the study. ``The data indicate, however, that patients treated with REMUNE tended to exhibit an even greater decrease in viral load when compared to the placebo group. The random cohort was sampled every three months for viral load. I believe that it is possible that the less frequent viral load sampling on the larger cohort which was obtained every six months (including a majority of the 435 patients on potent antiretroviral therapies at the beginning of the study), where little difference between the treatment groups was observed, impacted on the ability to detect effects of immunization on viral load. This is most likely due to the multiple antiviral drug switching which occurred during this trial. Most importantly, there was a correlation between the induced HIV specific T helper immune responses and control of the amount of virus in the blood. These findings further support the plausibility of the results in the random cohort. As the leading enrolling investigator in study 806, I am pleased that the details of this important information have been peer reviewed by HIV clinical experts and are now available to the HIV and scientific communities.``

``Most HIV-positive individuals lose the ability to recognize and respond to HIV soon after becoming infected despite treatment with antiretroviral drugs. The LPA results indicate that REMUNE may restore HIV specific T helper immune responses,`` said Dr. Turner. ``This is significant because HIV-1 specific immune responses, as shown by other investigators, are associated with the ability to control the level of virus in the blood in HIV-positive individuals who do not progress to AIDS. We observed for the first time a correlation between vaccine-induced HIV specific T helper responses in chronic HIV infection and control of virus.``

The 252 HIV-positive individuals involved in the published study were a randomly selected subset from a larger 2500-patient, multi-center, double-blind, adjuvant-controlled Phase 3 clinical study begun in 1996. All participants in the study were asymptomatic and had CD4 cell counts of 300-549cc/mm(3). There were no prerequisites as to the use of antiretroviral drug therapy; patients were allowed to take any combination of drugs and to switch combinations throughout the duration of the trial. Patients were randomized to receive intramuscular injections of either REMUNE or a placebo (Incomplete Freund`s Adjuvant) once every 12 weeks for 120 weeks. The trial was discontinued in May of 1999 when an independent data safety monitoring board determined that the trial would not reach statistical significance on the primary endpoints of progression to AIDS related illnesses or death (see Company Form 8-K dated May 14, 1999 and filed with the SEC on July 6, 1999). The trial was designed for a 6% per year rate of progression to AIDS or death as endpoints. During the trial, because of the fewer than expected clinical events, the endpoint definition was modified to include non-AIDS defining events. When the trial was stopped it was determined that the actual rate of progression to AIDS or deaths was <1% per year.

REMUNE is currently the subject of several clinical trials, including a Phase 2 trial being conducted in Spain and a Phase 3 trial sponsored by the Company`s partner Agouron Pharmaceuticals, Inc. (a Pfizer company) to evaluate REMUNE`s effect on viral load when administered in combination with potent antiviral drug therapy. Impact on viral load is now a measure of efficacy that is accepted by the Food and Drug Administration for approval of REMUNE.

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.

NOTE: News releases 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: http://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 preclinical data can be replicated in clinical trials, whether if initiated clinical trials will be successfully concluded and whether a preventative vaccine 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, 2000. The Company undertakes no obligation to publicly release the result 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.


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