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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
DATE OF REPORT: MAY 17, 1999
(Date of earliest event reported)
THE IMMUNE RESPONSE CORPORATION
(Exact name of registrant as specified in its charter)
DELAWARE 0-18006 33-0255679
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
5935 DARWIN COURT, CARLSBAD, CALIFORNIA 92008
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (760) 431-7080
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Item 5. OTHER EVENTS
The Immune Response Corporation (Nasdaq: IMNR) and Agouron
Pharmaceuticals, Inc. (Nasdaq: AGPH) announced today that an independent Data
Safety Monitoring Board (DSMB) completed a second interim analysis of the
2500-patient, placebo-controlled, Phase III clinical endpoint trial to
evaluate the immune-based therapy REMUNE(TM) added to patients' other
anti-HIV therapy. The DSMB recommended the trial be concluded at this time
because differences in clinical endpoints were not observed between treatment
groups and because extending the trial would be unlikely to provide
sufficient additional clinical endpoints to permit statistically significant
differences between the treatment groups to be observed in the near term. The
number of HIV-associated clinical endpoints observed in the trial was far
less than originally anticipated, which was believed to be the result of
increasing use of Highly Active Antiretroviral Therapy (HAART) including HIV
protease inhibitors, after the trial was initiated.
The Immune Response Corporation and Agouron Pharmaceuticals, Inc.
reported that separate analysis of a cohort of 250 patients randomly
pre-selected for surrogate marker analysis, showed a significantly greater
reduction in viral load (level of HIV RNA in plasma) after 48 and 96 weeks of
treatment and significantly greater increases in lymphoctye proliferation in
those who added REMUNE to their underlying anti-retroviral therapy, compared
with those who did not. The companies also reported that Agouron plans to
initiate two additional phase III surrogate marker trials of REMUNE in light
of an agreement previously reached with the Food and Drug Administration that
an application for the marketing of REMUNE could be submitted based upon
favorable virological endpoints.
The Immune Response Corporation and Agouron Pharmaceuticals, Inc.
entered into a collaboration in 1998 for the final development and
commercialization of REMUNE, an immune-based therapy for the treatment of HIV
infection.
This Form 8-K contains forward-looking statements. Actual results
could vary materially from those expected due to a variety of risk factors,
including whether or when additional clinical trials for REMUNE will be
initiated or successfully completed, and those risks set forth from time to
time 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, 1998. The
Immune Response Corporation 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.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Dated: May 18, 1999.
THE IMMUNE RESPONSE CORPORATION
By /s/ Dennis J. Carlo
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Dennis J. Carlo
President and Chief Executive Officer
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