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. Orphan designation will allow for a more speedy development of NeuroVax and will give us further flexibility in trial design. This is an important step in the process of bringing NeuroVax to market and getting through the clinical development phase. By filing for orphan designation for NeuroVax this will give IRBP and acclerated and expedited pathway to bring this important therapeutic vaccine for MS to market" 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-
Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net