- HIV Clinical Trials Terminated in Order to Redirect Resources -
CARLSBAD, Calif., April 4 /PRNewswire-FirstCall/ -- The Immune Response
Corporation (OTC Bulletin Board: IMRP) announced today that effective April
16 the company will be known as Orchestra Therapeutics, Inc. This new
corporate identity reflects the Company's expanded focus on the treatment
of autoimmune diseases. The Company will announce a new ticker symbol prior
to April 16.
"This is a transformative moment in the Company's history," said Dr.
Joseph O'Neill, President and CEO of The Immune Response Corporation. "We
believe we have a substantial opportunity to benefit patients living with
autoimmune diseases by concentrating our resources and further leveraging
the scientific technology pioneered with our investigational MS therapy
NeuroVax(TM)."
Autoimmune processes are implicated in more than 60 conditions,
including multiple sclerosis (MS), rheumatoid arthritis (RA), Crohn's
disease, psoriasis, lupus and type-1 diabetes. Orchestra Therapeutics'
unique approach to controlling autoimmune diseases uses small peptide
vaccines that appear to stimulate FOXP3+ Regulatory T-cells; a component of
the immune system that is now recognized as being key in autoimmune
pathogenesis.
In MS, for example, a specific subset of a patient's own white blood
cells, pathogenic T-cells, attack myelin, a fatty tissue in the central
nervous system, which surrounds and protects nerve fibers. This pathologic
process creates multiple areas of inflammation that ultimately lead to
scarring (sclerosis) and that interfere with normal transmission of nerve
impulses. This nerve damage, in turn, leads to a variety of chronic and
often debilitating neurological symptoms, ranging from serious movement and
balance problems to vision impairment.
NeuroVax(TM), an investigational T-Cell Receptor peptide vaccine for
the treatment of relapsing-remitting forms of MS, appears to work by
enhancing levels of FOXP3+ Regulatory T-cells within the immune system,
which may help control levels of pathogenic T-cells in MS patients. Data
from the Company's most recent Phase II clinical trial in MS showed that
reduced levels of FOXP3 can be restored to normal levels after repeated
vaccinations with NeuroVax(TM). The Company recently announced the
injection of the first patient in a large multi-center Phase II study to
assess the safety and efficacy of NeuroVax(TM).
Recognizing that a growing base of scientific research has demonstrated
the potential significance of the role of FOXP3+ Regulatory T-cells in the
prevention and treatment of a variety of autoimmune diseases, the Company
has made a strategic decision to emphasize this program and will redirect
its resources toward the execution and expansion of product development in
this area.
The Company is in discussions with several academic institutions to
conduct pre-clinical work on therapeutic vaccines to treat psoriasis and
RA. Based on findings to be derived from these product development
programs, the Company plans to initiate Phase I trials in one of these new
autoimmune areas in 2008.
The transition to the new name coincides with the Company's decision to
terminate the HIV clinical trials to fully focus the weight of the
Company's resources on the autoimmune program. The 52-week data from the
first large cohort of HIV clinical-trial participants have already been
gathered, and analysis of the data will be completed and disclosed in the
second quarter of 2007. Based on this data, the Company will consider
strategic alternatives for the HIV program.
Additionally the Company has decided to scale back operations at its
manufacturing facility in King of Prussia, Pennsylvania, effective
immediately. This decision will reduce costs by approximately $3 million
per year, while allowing the Company to maintain the facility pending
strategic decisions about the HIV program.
The Company raised $902,000, gross, from the exercise of warrants in
the last week of March 2007. These were from the second tranche of warrants
issued in the Company's spring 2006 Private Placement. Under special
amended terms, each exercising warrant holder received 2.5 common shares
for each $2 of exercise price paid. A total of 5,530,125 second tranche
warrants expired on March 30, thereby significantly reducing the Company's
overhang.
Orchestra Therapeutics, which will soon be the new name of The Immune
Response Corporation (OTC Bulletin Board: IMRP), is an
immuno-pharmaceutical company focused on the discovery and development of
novel treatments for autoimmune diseases. The Company's lead immune-based
therapeutic product candidate is NeuroVax(TM) for the treatment of MS. In
addition to MS, the Company has proprietary technology and prior clinical
experience for clinical evaluation of TCR peptide-based immune-based
therapies for RA and psoriasis. The targeted strategy behind the Company's
autoimmune therapies is reflected in the name Orchestra. Rather than
disrupting the function of the entire immune system, these therapeutic
vaccines are designed to elicit a very specific response -- akin to
correcting one instrument in an orchestra that is out of tune -- to help
control disease.
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 clinical trials of NeuroVax(TM),
REMUNE(R) 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), REMUNE(R) or IR103
might not prove to be effective as either a therapeutic vaccine, whether
future trials will be conducted and whether the results of such trials will
coincide with the results of NeuroVax(TM), REMUNE(R) or IR103 in
preclinical trials and/or earlier clinical trials and the unresolved status
of the Company's HIV program. 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's
Annual Report on Form 10-K for the year ended December 31, 2006 will be
filed soon and the set of risks set forth there should also be studied. 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.
MEDIA CONTACT:
Rachel Kessler
Chamberlain Communications Group Inc.
(212) 389-9155
rkessler@chamberlainpr.com
INVESTOR CONTACTS:
Robert Giordano
ROI Associates
(212) 495-0201
rgiordano@roiny.com
Gene Marbach
Makovsky & Company
(212) 508-9645
gmarbach@makovsky.com
COMPANY CONTACT:
Michael K. Green, COO
The Immune Response Corporation
(760) 431-7080
info@imnr.com
SOURCE The Immune Response Corporation
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CONTACT: Media, Rachel Kessler of Chamberlain Communications Group Inc., +1-212-389-9155, rkessler@chamberlainpr.com, for The Immune Response Corporation; or Investors, Robert Giordano of ROI Associates, +1-212-495-0201, rgiordano@roiny.com, for The Immune Response Corporation; or Investors, Gene Marbach of Makovsky & Company, +1-212-508-9645, gmarbach@makovsky.com, for The Immune Response Corporation; or Michael K. Green, COO of The Immune Response Corporation, +1-760-431-7080, info@imnr.com
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