CARLSBAD, Calif., Nov. 3 /PRNewswire-FirstCall/ -- The Immune Response
Corporation (Nasdaq: IMNR) announced today that it has initiated a preclinical
development program with IR103, a new vaccine candidate for the prevention and
treatment of HIV, the virus that causes AIDS. The program is based on the
promising results obtained from proof-of-concept studies with IR103, and is
designed to provide data that would support regulatory filings for Phase I
clinical studies. IR103 combines AMPLIVAX(TM), an adjuvant being developed by
Hybridon, Inc. (OTC Bulletin Board: HYBN) to enhance the immune response to a
vaccine antigen, with the HIV-1 Immunogen technology employed in Remune(R), an
immune-based therapeutic vaccine currently being evaluated in Phase II
clinical trials by The Immune Response Corporation for the treatment of HIV
infected individuals.
"We are very pleased to be moving forward with the IR103 development
program," said Georgia Theofan, Ph.D., Vice President of Clinical Development
at The Immune Response Corporation. "IR103 demonstrated significant HIV-
specific cell mediated immune responses in early preclinical studies. These
data confirm initial results indicating that the combination of our vaccine
antigen and immunomodulatory adjuvants such as AMPLIVAX can have a strong
effect on the overall immune response. Based on these results, we believe
that the new IR103 vaccine candidate could have broad prophylactic and
therapeutic applications that would complement our activities with Remune."
"IR103 is composed of two agents, the HIV-1 Immunogen from The Immune
Response Corporation, and AMPLIVAX, a second generation CpG DNA
immunostimulatory adjuvant that we recently licensed from Hybridon," noted
John N. Bonfiglio, Ph.D., Chief Executive Officer of The Immune Response
Corporation. "Both agents are currently in human clinical trials as stand
alone therapeutics. Having safety data from human studies for each of the
components should facilitate the clinical development of the combined product
candidate. We are eager to complete the IR103 preclinical development program
as quickly as possible with the goal of starting a Phase I clinical study
during the first half of 2004. The Company's recent success at fund raising
will allow us to initiate and complete this program according to our plan."
About The Immune Response Corporation and Remune (R)
The Immune Response Corporation is a biopharmaceutical company dedicated
to treating and preventing HIV and AIDS through the development of immune-
based therapeutic vaccines such as Remune, its lead product candidate. The
Company was co-founded by medical pioneer Dr. Jonas Salk, who was instrumental
in the formulation of Remune, which is currently in Phase II clinical
development.
HIV, the human immunodeficiency virus, is the virus that causes AIDS, a
condition that slowly destroys the body's immune system, making it vulnerable
to infections. Remune is designed to induce a specific immune response to the
HIV virus. It is comprised of HIV-1 virus that has been chemically killed and
inactivated so that it is non-infectious, plus an adjuvant that helps enhance
the body's immune response to the virus. More than 60 million people have
been infected with HIV since it was first recognized in 1981, and
approximately 40 million people around the world are living with HIV today.
This news release contains forward-looking statements. Actual results
could vary materially from those expected due to a variety of risk factors,
including whether the new vaccine candidate will be effective for the
prevention or treatment of HIV or whether it will enter into clinical trials,
whether The Immune Response Corporation will continue as a going concern and
successfully raise proceeds from financing activities sufficient to fund
operations and additional clinical trials of Remune, the uncertainty of
successful completion of any such clinical trials, whether Remune will be
effective as either a preventive or therapeutic vaccine, whether future trials
will be conducted and whether the results of such trials will coincide with
the results of Remune in preclinical trials. These risks, among others, are
set forth in The Immune Response Corporation's SEC filings including, but not
limited to, its Annual Report on Form 10-K for the year ended December 31,
2002, and subsequent Quarterly Reports on Form 10-Q. The Immune Response
Corporation 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 (R) is a registered trademark of The Immune Response Corporation.
For further information please contact:
The Immune Response Corporation
(Investors) - Kathy Lane, (760) 771-2236 or info@imnr.com
(Media) - Gwen Rosenberg, Rosenberg Business Communications, (858) 759-0759
SOURCE The Immune Response Corporation
 back to top
Related links:
http://www.imnr.com
CONTACT:
investors, Kathy Lane of The Immune Response
Corporation, +1-760-771-2236, info@imnr.com; or media, Gwen
Rosenberg of Rosenberg Business Communications, +1-858-759-0759,
for The Immune Response Corporation
|
