Immune Response BioPharma To Keep U.S. NeuroVax Rights For MS Expects Phase IIb Enrollment Q2 2015
PRLog (Press Release) - Nov. 24, 2013 - NEW YORK -- Immune Response BioPharma, Inc., Today Announces it plans to Keep U.S. NeuroVax Rights for MS Expects Phase IIb Enrollment to begin by Q2 2015 and business update.
* Phase IIb NeuroVax Study to Begin in Q3 2015 upon Successful Government Sponsored Grant Funding Approval in 2014.
* IRBP to Keep U.S. NeuroVax Rights for Multiple Sclerosis Given Safety Issues with Current MS Drugs & Regulatory Environment.
* IRBP Expects to receive Orphan Designation of NeuroVax for Pediatric Use.
"IRBP has entered into discussions with government funding agencies for funding NeuroVax development. We are in fruitful dialogue with the government for assistance with funding initiatives to develop NeuroVax and complete the Phase IIb work to move the vaccine to towards a much larger Phase III study and eventual FDA approval" Mr.Buswell CEO IRBP.
"Given the FDA response towards Lemtrada & safety issues raised and safety issues with current MS drugs we have decided to keep U.S. rights to NeuroVax although partnering will be available for global rights for Big Pharmas who are serious about co-development. Whether we go it alone or partner NeuroVax is perhaps the safest treatment option and effective option in particular for MS patients, it will be safety that wins out in this new landscape of safe yet effective treatment options. I will consider 50-50% for NeuroVax U.S. rights but big pharma will now have to dig deep into their pockets, we probably will not partner until we have our Phase IIb results which will give us further leverage" further commented Mr. Buswell CEO IRBP.
About NeuroVax:
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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Immune Response BioPharma, Inc.
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