FDA Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Designation may be granted on the basis of preclinical data. A sponsor of a drug that receives fast track designation will typically have more frequent interactions with FDA during drug development. In addition, products that have been designated as fast track can submit portions of a marketing application before submitting the complete application, known as rolling review.
"IRBP is pleased the FDA has chosen to designate NeuroVax for SPMS and recognizes its value in slowing disease progression in SPMS patients. IRBP thanks the FDA for its support for the vaccine approach to treat MS" IRBP CEO Mr. Buswell commented.
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-
Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net