CARLSBAD, Calif., July 17 /PRNewswire-FirstCall/ -- Orchestra
Therapeutics, Inc. (OTC Bulletin Board: OCHT) announced today the
discontinuation of its HIV Vaccine Development Program. Analysis of data
from 70 patients who completed a 52 weeks clinical trial in Europe and
Canada did not show a clear advantage of Orchestra Therapeutics' second
generation HIV vaccine, IR103, over its original whole-killed HIV vaccine,
REMUNE(R). Furthermore, although interim analysis of patients in this trial
at 36 weeks suggested a trend toward stabilization of CD4+ counts in HAART
naive patients vaccinated with REMUNE(R) or IR103, this trend was not
observed at week 52.
"While recognizing that the sample size is too small to achieve
statistical significance, these results are, nonetheless, less than we had
expected," said Joseph F. O'Neill, MD MPH President and CEO of Orchestra
Therapeutics. "We are deeply appreciative of the support that our
investors, clinical researchers, and patients have given to development of
this approach to an HIV vaccine and know that knowledge gained through our
efforts will contribute to the eventual discovery of an immune therapy for
HIV/AIDS. Our company, however, does not have the resources to move this
program forward at this time."
Dr. O'Neill also announced that Orchestra has contracted with
PharmaBioSource Realty, LLC to act as a broker to sell its HIV vaccine
production facility located in King of Prussia, Pennsylvania. "Selling the
assets of this facility will bring new capital into the company, help us to
further reduce our burn rate, and thereby strengthen Orchestra's potential
to emerge as the world's leading autoimmune immunotherapy company in the
months and years ahead."
Orchestra Therapeutics is exploring a number of strategic options for
disposition of its other HIV assets. These include sale or donation of its
HIV related intellectual property to an entity interested in pursuit of
whole killed HIV vaccine technology. Dr. Peter Salk, a member of
Orchestra's HIV Scientific Advisory Committee, commented that "The
rationale for investigation of a whole killed virus approach to an HIV/AIDS
vaccine remains strong. I trust that the effort that Orchestra Therapeutics
has made will stimulate other researchers' interest and effort in this
field. The HIV/AIDS epidemic is far too devastating to leave any stone
unturned in the quest for an effective vaccine."
About Orchestra Therapeutics
Orchestra Therapeutics, Inc., formerly The Immune Response Corporation
(OTC Bulletin Board: OCHT, formerly 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
evaluation of TCR peptide-based immune therapies for RA and psoriasis.
The targeted strategy behind the Company's immune-based 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), 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) might not prove to be effective as a therapeutic vaccine,
whether future trials will be conducted and whether the results of such
trials will coincide with the results of NeuroVax(TM) in preclinical trials
and/or earlier clinical trials. A more extensive set of risks is set forth
in Orchestra Therapeutics' SEC filings including, but not limited to, its
Annual Report on Form 10-K for the year ended December 31, 2006, and its
subsequent Quarterly Report 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.
NeuroVax(TM) is a trademark of Orchestra Therapeutics, Inc. REMUNE(R)
is a registered trademark of Orchestra Therapeutics, Inc.
MEDIA CONTACT: INVESTOR CONTACT:
Rachel Kessler Robert Giordano
Chamberlain Communications Group ROI Associates
(212) 389-9155 (212) 495-0201
rkessler@chamberlainpr.com rgiordano@roiny.com
COMPANY CONTACT:
Michael K. Green, COO
Orchestra Therapeutics, Inc.
(760) 431-7080
info@orchestratherapeutics.com
SOURCE Orchestra Therapeutics, Inc.
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Related links:
http://www.imnr.com
CONTACT:
Media, Rachel Kessler of Chamberlain
Communications Group, +1-212-389-9155,
rkessler@chamberlainpr.com, for Orchestra Therapeutics, Inc.; or
Investors, Robert Giordano of ROI Associates, +1-212-495-0201,
rgiordano@roiny.com, for Orchestra Therapeutics, Inc.; or Michael
K. Green, COO of Orchestra Therapeutics, Inc., +1-760-431-7080,
info@orchestratherapeutics.com
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