CARLSBAD, Calif., Aug. 30 /PRNewswire/ -- The Immune Response Corporation
(Nasdaq: IMNR) announced today that after a thorough review of the available
data, it has informed Agouron Pharmaceuticals, Inc. (a Pfizer Company
(NYSE: PFE)), the Company's former corporate partner, of the Company's
decision that it does not intend, and is not electing, to continue Agouron's
Study 202, a pivotal study of REMUNE(R), the Company's investigational immune-
based therapy to treat HIV infection. The decision was based on the fact that
the total number of endpoints (time to virological failure) to date appeared
to be falling short of the number assumed by Agouron in the protocol.
Additionally, the conditional power calculations (estimation of the likelihood
of correctly determining a treatment effect) provided by Agouron were reviewed
and revealed that while the power could be near 70%, it could also be as low
as 40%. Based on these factors, the Company determined that it would be
highly unlikely that Study 202 would be able to achieve its primary objective
of determining a treatment effect.
"In light of both our decision not to continue Study 202 and today's
announcement that the DSMB has expressed its view that the primary endpoint
was met in the REMUNE Phase II clinical trial (STIR 2102) in Spain, we plan to
meet with the appropriate regulatory authorities as soon as possible in both
Europe and the U.S. to discuss regulatory strategies regarding REMUNE," said
Dennis J. Carlo, Ph.D., President & Chief Executive Officer of The Immune
Response Corporation.
The primary objective of the randomized, double-blind, adjuvant-controlled
Study 202 was to determine whether the addition of REMUNE to a HAART regimen
of VIRACEPT(R) (nelfinavir mesylate) and COMBIVIR(R) delayed the time to
virologic failure (failure to fall below or a relapse above plasma HIV-1 RNA
levels of 50 copies/mL). The trial, commenced in September 1999, was to
continue for 48 weeks at designated sites in North America, Europe, and South
Africa. Eligible HIV-infected patients were to 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 were to receive
HAART in the following form: COMBIVIR(R) (zidovudine 300mg and lamivudine
150mg) twice daily (BID), and VIRACEPT(R) (nelfinavir mesylate) 1250mg twice
daily. Patients who achieved plasma HIV-1 RNA levels less than or equal to
2000 copies/mL were to be randomized to receive injections of either REMUNE or
placebo (Incomplete Freund's Adjuvant (IFA)). Those patients were to continue
to receive HAART and injections of either REMUNE or IFA administered once
every three months. It is the Company's understanding that Agouron will now
terminate its Study 202.
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: 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 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, 2000 and subsequent Forms 10-Q. 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(R) is a registered trademark of The Immune Response Corporation.
SOURCE Immune Response Corporation
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Related links:
http://www.imnr.com
Company News On-Call:
http://www.prnewswire.com/comp/434675.html
CONTACT:
Media, Jakob Jakobsen of Ogilvy Public
Relations, +1-310-407-7910, for Immune Response Corporation; or
Allison B. Small of Susan E. Atkins & Associates,
+1-858-860-0266, for Immune Response Corporation; or Investors,
Kathy Lane, +1-760-771-2236, for Immune Response Corporation
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