LA JOLLA, Calif., Sept. 27 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
and The Immune Response Corporation (Nasdaq: IMNR) today announced that a
pivotal trial has been initiated to further evaluate the safety and efficacy
of REMUNE(TM) (HIV-1 Immunogen), in combination with highly active
antiretroviral therapy (HAART), for the treatment of HIV infection. This
clinical trial is being conducted as part of the registration strategy for
REMUNE, an immune-based therapy currently in development. Previous clinical
studies have suggested that when combination antiviral drug therapy is
accompanied by intramuscular injections of REMUNE administered once every
three months, improvements in immunologic markers and positive trends in
virologic markers of the response to HIV are observed.
In clinical trials conducted to date with REMUNE, with or without
antiviral drug therapy, the most frequently reported side effects include
local transient pain, soreness and redness at the site of injection, muscle
aches, fatigue, and headache.
The primary objective of this randomized, double-blind,
adjuvant-controlled study is to determine whether the addition of REMUNE to a
HAART regimen of VIRACEPT(R) (nelfinavir mesylate) and COMBIVIR(R) delays the
time to virologic failure (failure to fall below or a relapse above plasma
HIV-1 RNA levels of 50 copies/mL). The trial will continue to 48 weeks at
designated sites in North America, Europe, and Australia.
Eligible HIV-infected patients must have plasma HIV-1 RNA levels of
greater than or equal to 10,000 copies/mL and no previous exposure to
antiretroviral therapy. All patients enrolled in the study will receive HAART
in the following form: COMBIVIR (zidovudine 300mg and lamivudine 150mg) twice
daily (BID), and VIRACEPT (nelfinavir mesylate) 1250mg twice daily. The
approved dose of VIRACEPT is 750mg three times daily. Patients who achieve
plasma HIV-1 RNA levels less than or equal to 2000 copies/mL will be
randomized to receive injections of either REMUNE or placebo (Incomplete
Freund's Adjuvant (IFA)). Those patients will continue to receive HAART and
injections of either REMUNE or IFA administered once every three months.
For more information on REMUNE clinical trials, dial toll-free
1-877-858-7783.
Agouron, a wholly owned subsidiary of Warner-Lambert Company (NYSE: WLA),
is an integrated pharmaceutical company engaged in the discovery, development
and commercialization of drugs for treatment of cancer, viral diseases, and
diseases of the eye. Agouron employs more than 1,000 people of whom
approximately 700 are engaged in research and development.
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 and autoimmune diseases. In
addition, the company is developing cancer vaccines and gene therapy.
VIRACEPT is indicated for the treatment of HIV infection when
antiretroviral therapy is warranted. This indication is based on analyses of
surrogate marker changes in patients who received VIRACEPT in combination with
nucleoside analogs or alone for up to 24 weeks. At present, there are no
results from controlled trials evaluating the effect of therapy with VIRACEPT
on clinical progression of HIV infection, such as survival or the incidence of
opportunistic infections.
The most commonly observed adverse event of moderate or greater severity
in clinical trials of VIRACEPT was diarrhea, which was generally controlled
with over-the-counter medications. New onset or exacerbation of diabetes
mellitus and hyperglycemia, and body fat redistribution, as well as increased
bleeding in patients with hemophilia types A and B, have been reported with
protease inhibitors.
For further information about Agouron Pharmaceuticals, Inc., or about
VIRACEPT, please dial toll free 1-888-VIRACEPT (847-2237). To receive full
prescribing information for VIRACEPT via fax, dial 1-888-288-9639.
VIRACEPT(R) and Agouron(R) are registered trademarks of Agouron
Pharmaceuticals, Inc.
REMUNE(TM) is a trademark of The Immune Response Corporation.
COMBIVIR(R) is a registered trademark of Glaxo Wellcome Oncology/HIV.
SOURCE Agouron Pharmaceuticals, Inc.
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Related links:
http://www.agouron.com
Company News On-Call:
http://www.prnewswire.com/comp/019650.html or fax,
800-758-5804, ext. 019650
CONTACT:
Joy Schmitt, Associate Director, Product
Public Relations, of Agouron Pharmaceuticals, Inc., 858-622-3220;
or Creighton Lawhead, Vice President, Commercial Affairs &
Investor Relations of The Immune Response Corporation,
760-431-7080
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