PRLog (Press Release) - Dec 10, 2012 -- Immune Response BioPharma, Inc. Today Announces New ZORCELL Psoriasis Vaccine Phase IIb Study Safety & Efficacy 350 Patients ZORCELL + Methotrexate 6 Months Study.
IRBP's new clinical study will test safety & efficacy of ZORCELL the first psoriasis vaccine in combination with the standard comparable Methotrexate for six months.
"This is an exciting time for IRBP to bring the first psoriasis vaccine to market with an estimated $8 billion market by 2020 this is an exploding treatment area to be in. We are in the right place and the right time to bring this wonderful vaccine to market for psoriasis. IRBP is very proud of our vaccine candidate for psoriasis as it has a superior safety profile, the all natural protein based peptides are extremely safe and work to down regulate and shut down those aberrant T Cells that have gone awry. We are in active discussions with potential partners to bring the first psoriasis vaccine to market and help those afflicted with this incurable disease. IRBP's expertise in TCR peptide therapy will help propel our small biopharma into the preeminent and defacto leader in vaccine technology" IRBP CEO Mr. Buswell.
ZORCELL Phase IIb Study Protocol available @ https://skydrive.live.com/redir?resid=310AB990382AE320!13...
Psoriasis is a T cell-mediated autoimmune disease of the skin in which the pathology is complex but clearly involves activated T lymphocytes. The chronological steps in lymphocyte activation leading to the development of the psoriatic lesion are thought to include initial systemic activation and induction of specific CD4+ T cells, with infiltration and local accumulation of these specific CD4+ T cells in the skin, followed by recruitment of non-specific CD4+ lymphocytes and monocytes, and finally clonal intra-epidermal expansions of CD8+ lymphocytes. There are several compelling lines of evidence for T cell involvement in psoriasis, including the initiation of psoriatic lesions in immunodeficient mice after transfer of superantigen or IL-2 activated peripheral blood leukocytes from psoriasis patients. In addition, intra-epidermal CD8+ T cells isolated from plaque regions were found to be oligoclonal, expressing BV3 and BV13S1 genes in their TCRs. Finally, early stage elimination of activated T cells using IL-2 fusion toxin has therapeutic benefit.
In a previous Phase II Study with ZORCELL Patients injected with 40 mer peptides in IFA had measurable T cell proliferation immunogenic responses . Overall, significant immunological responses to peptide in either adjuvant were related to a 25-28% decrease in the psoriasis area and severity index (PASI). Overall, these early studies suggest a modest clinical effect of TCR peptide vaccination in psoriasis.These results are not too surprising given the current knowledge we now have on lymphocyte activation and the relatively late appearance of targeted CD8+ T cells in the psoriatic lesions, down-regulation of the specific early activated CD4+ and CD8+ T cells in the lesions may be possible using TCR peptide vaccines. Utilizing available agents that have broader but transient effects on PASI scores, such as anti-LFA antibody, followed by vaccination with TCR peptides to retard formation of new lesions and delay time to flare.
Immune Response BioPharma, Inc. maybe found on the World Wide Web @