OHSU tests MS drug in clinical trial

Portland Business Journal - 10:35 AM PDT Monday, May 21, 2007

A 55-year-old Montesano, Wash., woman will be the first person in the Northwest to be treated with a promising developed entirely at Oregon Health & Science University and the Portland Veterans Affairs Medical Center.

Anne Foster, who has secondary-progressive MS, will be the third person in the country to receive an infusion of the OHSU/VAMC-invented drug, RTL1000, as part of a Phase I trial when she arrives Monday for treatment at OHSU's Center for Health & Healing. She will be awake as the drug is administered intravenously and will stay in the hospital for 24 hours for evaluation.
During the Phase I trial on RTL1000, initiated by Tigard-based Artielle ImmunoTherapeutics Inc., researchers will test the drug in a total of 30 participants at six study sites, including OHSU, Yale University, Indiana University, University of Kansas Medical Center, University of Maryland, and the MS Center at Evergreen, in Kirkland, Wash. They will evaluate its safety, determine a safe dosage range and identify side effects.

OHSU and VAMC researchers who developed RTL1000 are enthusiastic about the drug's potential. Named for the "recombinant T-cell receptor ligand" that is the center of its activity, RTL1000 is a highly selective protein that binds to disease-causing white blood cells, or T-cells, and inactivates them.

MS is caused by a subgroup of pathogenic T-cells that attack myelin, the fatty sheath insulating nerve fibers in the brain and spinal cord, and cause the fibers to lose their ability to conduct impulses. RTL1000 was bioengineered to bind specifically to the T-cells believed to cause MS, and then inactivate or "stun" these cells.

Arthur Vandenbark, a professor of neurology and molecular microbiology and immunology at the OHSU School of Medicine, and senior research career scientist at the VAMC, led the RTL1000 research team that included Halina Offner, a professor of neurology and anesthesiology and peri-operative medicine at OHSU and the VAMC, and Gregory Burrows, OHSU research associate professor of neurology.

Vandenbark called the clinical trial with RTL1000 "the holy grail" of his research.

In early studies that Vandenbark, Offner and Burrows conducted on mouse models for MS, RTL1000 appeared to reverse demyelination and nerve fiber damage. That meant the drug was both neuroregenerative and neuroprotective.

RTL1000's appearance in a clinical trial is the culmination of more than 20 years of work by MS scientists and clinicians at OHSU and the VAMC to develop a treatment that enhances the body's natural ability to control disease-causing T-cells. They recently helped launched an international trial for another MS drug invented by Vandenbark and Offner, called NeuroVax, that boosts the activity of protective T-cells that regulate MS. This treatment approach, referred to as T-cell receptor peptide vaccination, may also prove useful for treating a variety of autoimmune diseases, such as diabetes mellitus and rheumatoid arthritis.

http://www.bizjournals.com/portland/stories/2007/05/21/daily6.html

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Subject:	Orchestra Therapeutics to Present at Red Chip Small-Cap Investor Conference - Health - RedOrbit
Date:	Thu, 24 May 2007 19:08:09 -0400
From:	Bill
To:	smyrnios

Orchestra Therapeutics to Present at Red Chip Small-Cap Investor Conference

CARLSBAD, Calif., May 24 /PRNewswire-FirstCall/ -- Orchestra Therapeutics, Inc. (BULLETIN BOARD: OCHT) today announced that a presentation about the Company's new corporate identity and expanded focus on the treatment of autoimmune diseases will be given at the Red Chip Small-Cap Investor Conference in San Francisco, Wednesday, May 30, 2007. The annual conference represents an opportunity for Orchestra Therapeutics to discuss its immune-based therapeutic vaccine program with global investors and leading financial professionals in the small-cap industry.

Dr. Joseph O'Neill, Orchestra Therapeutics President and CEO, will make the presentation. Dr. O'Neill will discuss the Company's drug development pipeline, including the status of the double-blind, placebo controlled Phase II clinical trial now in progress for NeuroVax(TM), a T-Cell Receptor peptide vaccine for the treatment of relapsing-remitting forms of multiple sclerosis (MS).

"We believe we have a substantial opportunity to benefit patients living with various autoimmune diseases by further leveraging the scientific technology pioneered with NeuroVax(TM)," said Dr. O'Neill. "We are currently in final discussions with various prestigious academic institutions about conducting pre-clinical work with human samples toward the development of several therapeutic vaccines to treat other autoimmune diseases including psoriasis and rheumatoid arthritis (RA). We expect the findings from these programs to position us to initiate Phase I trials of a TCR peptide vaccine in at least one of these new autoimmune diseases in 2008."

Autoimmune processes are implicated in more than 90 conditions, including MS, RA, psoriasis, Crohn's disease, lupus and type-1 diabetes. Orchestra Therapeutics' unique approach to controlling autoimmune diseases uses small TCR peptide vaccines that appear to stimulate strong disease immunity that includes Foxp3+ Regulatory T-cells; a component of the immune system that is now recognized as being key in autoimmune pathogenesis. The Company was one of the first to demonstrate that these T Reg cells were diminished in MS patients, and has subsequently shown that NeuroVax(TM) can replenish the levels of these T Reg cells back to or greater than those seen in healthy controls.

Dr. O'Neill added, "We look forward to learning more about the clinical impact of NeuroVax(TM) and to potentially expanding our product portfolio based on this platform technology. We believe we have cause to be excited about future developments for the Company."

As part of the presentation, Dr. O'Neill will also provide updates on key decisions made by the Company to reduce costs and focus resources on the expanded autoimmune program.

About Orchestra Therapeutics

Orchestra Therapeutics, Inc. (BULLETIN BOARD: OCHT) , formerly The Immune Response Corporation (former symbol 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 Company also has two HIV product candidates, REMUNE(R) and IR103. The 52-week data from the first large cohort of HIV clinical trial participants from a now-terminated Phase II clinical trial 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.

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), 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 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 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 Reports as 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

Orchestra Therapeutics, Inc.

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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