Immune Response bricht aus. Hier die Meldung. - 500 Beiträge pro Seite

[doktore2]

Wenn Remune zugelassen wird, winkt ein Milliardenmarkt. Hier die Meldung, die in Deutschland schon eine kleine Kursexplosion ausgelöst hat. Doktore2



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., Jul 13, 2000 /PRNewswire via COMTEX/ -- The Immune Response
Corporation (Nasdaq: IMNR) 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: http://www.imnr.com.

[Deppi]

Kommt mal zu http://www.uptotrade.de ins BIOTECH-Forum!

[Deppi]

[03516]

Noch mehr News von heute 14.7.
Brigitte




INVESTOR RELATIONS
News




Clinical Data on REMUNE(TM) (Investigational HIV-1 Immunogen) Selected as a Late Breaker Presentation at the XIII International AIDS Conference in Durban, South Africa

Preliminary Results Suggest the Investigational Use of HIV Immune-Based
Therapy Alone or in Combination With Antiviral Drugs to Treat
HIV-Infected Individuals

CARLSBAD, Calif., July 14 /PRNewswire/ -- The Immune Response Corporation
(Nasdaq: IMNR) announced today that Trinity Medical Group, the Company`s
licensee for development of REMUNE in Southeast Asia, has informed the Company
that follow-up data from the Phase II clinical trial conducted in Thailand
were presented at the XIII International AIDS Conference in Durban, South
Africa.
In a late-breaker oral presentation, Vina Churdboonchart, Ph.D., of
Mahidol University, Bangkok, Thailand, reported an update on preliminary
results from a follow-up study of HIV-infected people who were previously
enrolled in a 40-week Phase II trial of Remune in Thailand for which she was
the Principal Investigator. The main objective of the Phase II trial was to
determine the effect of Remune as a monotherapy on CD4 helper T cells, which
are the primary targets of HIV. Patients treated with Remune had
significantly higher CD4 counts (an average increase of 84 CD4 cells) compared
to the placebo group at the end of the 40-week placebo controlled trial.
Furthermore, the increase in CD4 cells was associated with increased immune
activity against the virus, as measured by delayed type hypersensitivity skin
tests (a measure of cell mediated immunity against HIV) and western blot (a
measure of antibodies against HIV).
Upon conclusion and unblinding of the Phase II trial, all patients were
allowed to participate in an on-going open-label extension study with
continued Remune treatments every 12 weeks without concomitant antiviral drug
therapy. Patients are being monitored for changes in immune responses,
including number of CD4 helper T cells (specialized white blood cells), in
addition to body weight (an indicator of general health) and viral load (the
amount of replicating HIV in the bloodstream).
A total of 27 HIV-infected patients participating in the open-label study
have completed an additional 96 weeks (total of 136 weeks) of receiving Remune
as a monotherapy. Results were reported as a comparison of measurements taken
at baseline (at the conclusion of the original 40-week trial) and at
136 weeks. For the entire group, on average, CD4 counts increased by
100 cells, body weight increased by 1.05 kilograms, and viral load remained
stable (4,800 copies HIV RNA per mL at baseline vs. 4,700 copies HIV RNA per
mL at 136 weeks).
"At the end of the 40-week trial, patients treated with Remune experienced
a significant increase in CD4 cells compared to the placebo group. In the
subset of patients reaching 136 weeks, we are seeing an even greater increase
in CD4 cells with specific activity against HIV, which suggests that improved
immune responses may be the result of prolonged treatment with Remune," said
Dr. Churdboonchart. "Equally notable is that even without antiviral drug
therapy, viral load has remained stable on average for nearly three years in
this subset of patients." Dr. Churdboonchart added that the patients selected
for the Phase II trial were asymptomatic and relatively healthy individuals,
such that the observed positive immune responses to treatment with Remune
underscore the importance of early intervention to management of HIV
infection.
"These data are particularly relevant for this year`s AIDS meeting in
Africa as they suggest one potential strategy for slowing the AIDS epidemic in
developing countries where access to antivirals is limited," Dr.
Churdboonchart continued. "These results support our proposal to Thai health
authorities that Remune should be used as a first line therapy, with
cost-effective antivirals added on for non-responding patients. The stability
of these patients receiving REMUNE alone is comparable to that of clinical
non-progressors. These new data will be submitted to the Thai Ministry of
Public Health (the Thai FDA)."

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: 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 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







Web site: http://www.imnr.com


Company News On-Call: http://www.prnewswire.com/comp/434675.htmlor fax, 800-758-5804, ext. 434675


CONTACT: Kathy Lane of The Immune Response Corporation,760-771-2236

[shadow00]

Ich dachte immer IMMUNE RESPONSE befindet sich in Thailand in der Phase III. Nach dem Bericht aber Phase II. Weiss jemand wann Phase III beginnt und wie lange diese durchschnittlich dauert?