IRBP will extend its focus on RA by expanding RAVAX™ into the area of Juvenile Rheumatoid Arthritis, (JRA) is a term used to describe a common type of arthritis in children. It is a long-term (chronic) disease resulting in joint pain and swelling. JRA affects approximately 50,000 children in the United States. Inflammation causes redness, swelling, warmth, and soreness in the joints.
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.
Immune Response BioPharma, Inc.'s proprietary technology for RAVAX™ seeks to identify unique T cell receptor proteins and determine their peptide sequence. These peptides can then be artificially synthesized and used to vaccinate the patient. The Company believes that by vaccinating with T cell receptor peptides specific to the autoreactive T cells, the therapy may induce the immune system to down-regulate turn off the aberrant T cells without affecting other normal cells. Vaccination holds the appeal of not only providing a specific therapy without global immunosuppression, but also utilizing normal pathways of immune system self regulation.
DNA vaccines encoding key "superantigen"
"RAVAX is a first in class and best in class vaccine for Rheumatoid Arthritis, which works by down regulating aberrant T cells and treating the underlining causes of the RA disease. Orphan designation will allow for a more speedy development of RAVAX and will give us further flexibility in trial design and expand the RA Vaccine use into the rare disease JRA. This is an important step in the process of bringing RAVAX to market and getting through the clinical development phase. By filing for orphan designation for RAVAX this will give the RA Vaccine expanded use and allow IRBP an acclerated and expedited pathway to bring this important therapeutic vaccine for RA to market. IRBP is currently seeking a big pharma partner to co-develop RAVAX and initiate our Phase 3 Study for RA and we continue to have active discussions with our potential partners. IRBP will likely license both NeuroVax for MS & RAVAX for RA to the same corporate partner to guarantee their success in the clinic. We hope to have a partner secured in coming months" Mr. Buswell CEO IRBP.
About RAVAX™ the first RA Vaccine it has completed two Phase II clinical trials in rheumatoid arthritis using IRBP's proprietary immune-based therapy based on TCR peptide vaccines. In a phase IIb trial of 340 rheumatoid arthritis patients, RAVAX demonstrated safety and tolerability, and suggested a statistically significant treatment effect after the third injection using criteria established by the American College of Rheumatology (ACR 20). The ACR 20 criteria require an improvement in tender and swollen joint counts of at least 20% from baseline, along with improvement in three of five other disease-related criteria.
Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net