Immune Response BioPharma, Inc, has submitted an application to the US Food and Drug Administration for an orphan designation for its new vaccine, Ravax, which targets the immune system of patients with juvenile rheumatoid arthritis (RA).
“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 [juvenile RA], said David Buswell, Chief Operating Officer and Interim Chief Executive Officer of Immune Response BioPharma. The drug’s manufacturer believes that through vaccination with T-cell receptor peptides specific to the autoreactive T-cells, the patient’s immune system may be stimulated to downregulate and turn off the aberrant T-cells without involving normal cells. Ravax provides specific treatment without total immunosuppression, and, at the same time, uses typical pathways of self-regulating the immune system.
The filing of the new application is seen as a step forward in the development of this unique vaccine for patients with juvenile RA, charting a new approach to therapy for this patient population.
Immune Response BioPharma believes that the new vaccine may inhibit the T-cells that cause RA, which could prevent the development of or the deterioration of RA. The company has completed two phase 2 clinical trials with Ravax in patients with RA. A phase 2b trial with the vaccine involving 340 patients with RA showed a significant treatment response after the third injection using the American College of Rheumatology 20% response rate criteria (ACR20) in reducing swollen joint counts. Immune Response BioPharma, Inc, press release, October 23, 2012