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Immune Response BioPharma, Inc. Logo

Immune Response BioPharma, Inc. to Develop Zorcell the First Psoriasis Vaccine

Immune Response BioPharma, Inc. to Develop Zorcell Psoriasis Vaccine the First Vaccine for Psoriasis & Reviews Phase II Results

PRLog - Nov. 3, 2012 - Immune Response BioPharma, Inc. to Develop Zorcell the First Psoriasis Vaccine & Reviews Phase II Results.

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.

Zorcell Psoriasis Phase II Vaccine Multicenter Study Double Blind Placebo and Adjuvant-Controlled Trial of TCR Peptide Vaccination in Psoriasis Vulgaris
Using a Combination of BV3 and BV13S1 20 mer or 40 mer
CDR2 peptides (Gottlieb et al. in Preparation)
Study Design
-Treatment regimen
84 Psoriasis patients, BV3 and BV13S1 CDR2 20 mer or 40 mer
100 mg (50 mg each) peptide/IFA, peptide/Detox ™PC, or
peptide/Saline, or vehicles alone
Three i.m. injections (weeks 0, 4, 8)
-Monitoring over 16 weeks
T cell proliferation responses and antibodies to each peptide
Delayed type hypersensitivity (DTH) responses to peptides
Clinical grading of lesions and Psoriasis Area and Severity
Index (PASI)
Study Results
Higher number of adverse events in Detox ™PC and Saline
groups versus IFA group
Overall, TCR peptide immunization appeared to be safe and
well tolerated
-Immunological responses
Increased proliferation responses to peptides in both
peptide/adjuvant treatment groups
Immunogenicity of 40 mers/adjuvants . 20 mers/adjuvants .
adjuvants or peptides/saline
DTH responses to peptides sporadic but not different among
No antibody responses to peptides
-Clinical responses
Clinically meaningful PASI changes in IFA group (40 mer,
28%; 20 mer, 17%; IFA, 7%)
No clinically meaningful changes in Detox ™PC or Saline
No significant difference in target lesion score improvement in
any treatment group
-Maximal clinical effects (25% reduction of PASI scores) observed
with 40 mers in IFA within 4 weeks of peptide booster injection
-Immunological response to peptide/IFA related to 20% PASI
changes (40 mer 5 20 mer . controls)
-Peptides in Detox ™PC showed higher rates of adverse
reactions, were less immunogenic and yielded lower clinical
benefits (PASI)
-Peptides in saline weakly immunogenic with positive clinical trend

Conclusions & Discussion of Results:
Patients injected with 20 mer or 40 mer peptides in IFA had measurable but sporadic T cell proliferation responses to peptide,with the 40 mers appearing to be somewhat more immunogenic than the 20 mers. Peptides in saline were less immunogenic. Overall, significant immunological responses to peptide in either adjuvant were related to a 20% 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.

"IRBP will extend its TCR Vaccination technology and pipeline by developing Zorcell the first psoriasis vaccine. Zorcell used in combination with current psoriasis drugs may be a potent and powerful therapy to knock out psoriasis and give patients a safe alternative to current treatments. What we have learned from the previous studies is monthly dosing is optimal and to use the vaccine in combination with current treatments. IRBP will seek a partner for the new psoriasis Phase IIb study we are planning to co-develop Zorcell and bring this wonderful vaccine for psoriasis to market, demonstrating why IRBP is the quickly becoming the leader in vaccine technology worldwide" IRBP CEO Mr. Buswell

Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net

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Contact Email:
***@immuneresponsebiopharma.com Email Verified
Source:Immune Response BioPharma, Inc.
Phone:(917) 275-7931
City/Town:New York City - New York - United States
Industry:Biotech, Health
Tags:Immune Response BioPharma Inc., psoriasis, vaccine, drug, treatment
Last Updated:Nov 03, 2012
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