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Immune Response BioPharma to Seek Fast Track & Orphan Designation of NeuroVax for SPMS
9/4/2013 9:11:01 AM
PRLog (Press Release) - Sep. 3, 2013 - NEW YORK -- Immune Response BioPharma, Inc. Today, Announces plans to seek Fast Track & Orphan Designations of Blockbuster Drug/Vaccine NeuroVax for a new indication of Secondary Progressive Multiple Sclerosis. SPMS effects approximately 35% of MS patients and is under the 200,000 threshold in the U.S.A. and NeuroVax is the first vaccine to be developed for this debilitating rare disease.
Secondary Progressive MS follows an initial period of relapsing-remitting MS the most common form of MS in people who are newly-diagnosed. In SPMS, the disease begins to worsen more steadily, with or without occasional attacks, slight remissions, or plateaus. Of the 85 % of people initially diagnosed with RRMS, approximately half will transition to SPMS within 10 years, and 90% will transition within 25 years.
The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.
Orphan Drug Designation carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an expedited regulatory process.
"NeuroVax is a first in class and best in class vaccine for multiple sclerosis, which helps to restore deficient FOXP3+ Tregs and treat the underlining causes of the disease. By seeking Fast Track & Orphan Designation for patients with SPMS this will expand the use of NeuroVax & allow for a more speedy development of the drug. This also gives us a niche indication of MS to go after, as well it will give us further flexibility in trial design. Orphan designation for SPMS use of NeuroVax this will give IRBP and accelerated and expedited pathway to bring this important therapeutic vaccine for MS to market & treat this rare disease. We continue to seek a partner for co-development of this wonderful treatment for MS" Mr. Buswell CEO IRBP.
NeuroVax is a Once a Month Dosing injection, Safe, Tolerable, Enhances FOXP3+ Tregs & Regulates Pathogenic T Cells in MS Patients, a First in Class Disease Modifying Multiple Sclerosis Vaccine.
NeuroVax™ has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all treated patients. NeuroVax™ 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 TCRpeptides combined in NeuroVax™ correspond to one or more TCRgene families which are over expressed in 90% of MS patients. Previous clinical trials conducted by the Company and other independent researchers including a 27 patient clinical trial of NeuroVax have associated diminished levels of Foxp3+ Treg responses with the pathogenesis and progression of MS.This same mechanism appears to be important in the pathogenesis of other autoimmune diseases such as RA and psoriasis. Monthly vaccinations over one year with NeuroVax™ markedly expanded the capacity of regulatory T cells (Tregs) to recognize TCRs expressed by potentially pathogenic T cells. New data were also presented that showed NeuroVax™ produced a significant increase inTCR-specific T cells in patients with MS,including increases in interleukin-10-secreting T cells (IL-10) and Foxp3+ Tregs.
Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net
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