- Company Admits No Fault and Settlement Is Covered by Insurance -
CARLSBAD, Calif., Nov. 14 /PRNewswire-FirstCall/ -- The Immune Response
Corporation (OTC Bulletin Board: IMNR) announced today that the Company has
reached an agreement with class counsel to settle the consolidated federal
securities law class action litigation filed against the Company in 2001,
as well as the related California state-court derivative lawsuit, without
admitting to any wrongdoing, fault or liability. The settlements also
include Company directors and officers who were named in the lawsuits.
The class action settlement, for approximately $9.6 million, will have
no effect on the Company's operations, cash flow or financial position, as
it is within insurance limits. The settlement is conditioned on notice to
the class members and court approval. The preliminary settlement approval
hearing is scheduled to occur on December 4, 2006.
The shareholder derivative complaint was filed on July 5, 2005 against
certain of the Company's current and former officers and directors. The
Company was also named as a nominal defendant in the complaint.
The $0.25 million settlement for the California state-court derivative
lawsuit would also be funded entirely by the Company's insurers. As
anticipated by an agreement in principle for the settlement, the Company
will also agree to adopt certain corporate governance requirements. The
definitive state-court settlement agreement is conditioned on court
approval and must be filed with the court by November 20, 2006. The
settlement hearing is scheduled to occur on November 27, 2006.
About The Immune Response Corporation
The Immune Response Corporation (OTC Bulletin Board: IMNR) is an
immuno-pharmaceutical company focused on developing products to treat
autoimmune and infectious diseases. The Company's lead immune-based
therapeutic product candidates are NeuroVax(TM) for the treatment of
multiple sclerosis (MS) and IR103 for the treatment of HIV infection. Both
of these therapies are in Phase II clinical development and are designed to
stimulate pathogen-specific immune responses aimed at slowing or halting
the rate of disease progression.
NeuroVax(TM), which is based on the Company's patented T-cell receptor
(TCR) peptide vaccine technology, has shown potential clinical value in the
treatment of relapsing forms of MS. NeuroVax(TM) has been shown to
stimulate strong, disease-specific cell-mediated immunity in nearly all
patients treated and appears to work by enhancing levels of FOXP3+ Treg
cells that are able to down regulate the activity of pathogenic T-cells
that cause MS. Increasing scientific findings have associated diminished
levels of FOXP3+ Treg cell responses with the pathogenesis and progression
of MS and other autoimmune diseases such as rheumatoid arthritis (RA),
psoriasis and Crohn's disease. In addition to MS, the Company has open
Investigational New Drug Applications (IND) with the FDA for clinical
evaluation of TCR peptide-based immune-based therapies for RA and
psoriasis.
IR103 is based on the Company's patented, whole-inactivated virus
technology, co-invented by Dr. Jonas Salk and indicated to be safe and
immunogenic in extensive clinical studies of Remune(R), the Company's first
generation HIV product candidate. The federal class action litigation was
based on the Company's reporting of results from one of those clinical
studies of Remune(R). IR103 is a more potent formulation that combines its
whole-inactivated antigen with a synthetic Toll-like receptor (TLR-9)
agonist to create enhanced HIV-specific immune responses. The Company is
currently testing IR103 in two Phase II clinical studies as a first-line
treatment for drug-naive HIV-infected individuals not yet eligible for
antiretroviral therapy according to current medical guidelines.
NeuroVax(TM) and IR103 are in clinical development by The Immune
Response Corporation and are not approved by any regulatory agencies in any
country at this time. Please visit The Immune Response Corporation at
http://www.imnr.com.
This news release contains forward-looking statements. Forward-looking
statements are often signaled by forms of words such as should, could,
will, might, plan, projection, forecast, expect, guidance, potential and
developing. Actual results could vary materially from those expected due to
a variety of risk factors, including whether the Company will continue as a
going concern and successfully raise proceeds from financing activities
sufficient to fund operations and additional clinical trials of
NeuroVax(TM) or IR103, the uncertainty of successful completion of any such
clinical trials, the fact that the Company has not succeeded in
commercializing any drug, the risk that NeuroVax(TM) or IR103 might not
prove to be effective as either a therapeutic or preventive vaccine,
whether future trials will be conducted and whether the results of such
trials will coincide with the results of NeuroVax(TM) or IR103 in
preclinical trials and/or earlier clinical trials. A more extensive set of
risks is 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, 2005, and its subsequent Quarterly Reports filed on Form
10-Q. The Company undertakes no obligation to update the results of these
forward-looking statements to reflect events or circumstances after today
or to reflect the occurrence of unanticipated events.
REMUNE(R) is a registered trademark of The Immune Response Corporation.
NeuroVax(TM) is a trademark of The Immune Response Corporation.
INVESTOR CONTACTS: COMPANY CONTACT:
Gene Marbach Michael K. Green, COO and CFO
Makovsky & Company The Immune Response Corporation
(212) 508-9645 (760) 431-7080
gmarbach@makovsky.com info@imnr.com
Robert Giordano
ROI Associates
(212) 495-0201
rgiordano@roiny.com
SOURCE The Immune Response Corporation
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Related links:
http://www.imnr.com/
CONTACT:
Gene Marbach of Makovsky & Company,
+1-212-508-9645, gmarbach@makovsky.com; or Robert Giordano of ROI
Associates, +1-212-495-0201, rgiordano@roiny.com, both for The
Immune Response Corporation; or Michael K. Green, COO and CFO of
The Immune Response Corporation, +1-760-431-7080, info@imnr.com
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