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Orchestra Therapeutics Announces New Phase II Clinical Data on,NeuroVax Demonstrating Marked Expansion of Regulatory T Cell,Populations in Patients With Multiple Sclerosis

ax(TM) may be able to exert broad and potent immunomodulatory effects on pathogenic T cells," said Dr. Joseph O'Neill, President and CEO of Orchestra Therapeutics, Inc. "The indication that this vaccine candidate increases both native and induced types of Foxp3+ Tregs against a broad population of pathogenic T cell families is also important as it provides further insight into the targeted mechanism of NeuroVax(TM). Orchestra Therapeutics is investigating how this TCR peptide vaccine technology, pioneered with NeuroVax(TM), could be leveraged to develop similar therapeutic vaccines for other autoimmune diseases such as rheumatoid arthritis (RA) and psoriasis."

In MS, 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), which is currently being tested in a double-blind, placebo-controlled 200-patient Phase II study, may represent a significant advance in the treatment of MS, which affects more than 2.5 million people worldwide, including more than 400,000 in the United States. NeuroVax(TM) has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all treated patients. NeuroVax(TM) appears to work in part by enhancing levels of Foxp3+ Tregs, which may help regulate expression of pathogenic T cells in MS patients. The three TCR peptides combined in NeuroVax(TM) correspond to one or more TCR gene families which are over expressed in 90% of MS patients. Previous clinical trials conducted by the Company and other independent researchers have associate
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