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Immune Response BioPharma, Inc. TM        Copyright (c) 2010-2017

RAVAX TM  Rheumatoid Arthritis Vaccine 

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RAVAX TM IR501 & IR703 Phase 3: RHEUMATOID ARTHRITIS VACCINE

01/10/2014 U.S. Non Provisional Patent Application Filing #14152947 
                  TCR Peptides Vaccination & Methods Against RA Rheumatoid Arthritis  
 undefined                                         
Rheumatoid Arthritis is a chronic long term disease and a form of inflammatory arthritis known as an autoimmune disease. In RA, for reasons no one fully understands, the immune system – which is designed to protect our health by attacking foreign cells such as viruses and bacteria – instead attacks the body’s own tissues, specifically the synovium, a thin membrane that lines the joints. As a result of the attack, fluid builds up in the joints, causing pain in the joints and inflammation that’s systemic – meaning it can occur throughout the body. RA is a chronic disease that causes pain, stiffness, swelling and limited motion and function of many joints. While RA can affect any joint, the small joints in the hands and feet tend to be involved most often. Inflammation sometimes can affect organs as well, for instance, the eyes or lungs.
Rheumatoid Arthritis – 2.1 million + patients in the U.S.– 3-4% of the global population 75% of Patients are Women
 

RAVAX PHASE IIB: Phase 2B RAVAX Results

 

Multicenter Double Blind Adjuvant-Controlled Trial

of TCR Peptide Vaccination in Rheumatoid Arthritis Using a

Combination of BV3, BV14, and BV17 20 mer or 40 mer CDR2

Peptides (in Preparation)

 

Study Design

-Treatment regimen

340 RA patients, BV3, BV14, and BV17 CDR2 peptides,

17–20 mers or 40 mers

30 mg (10 mg each) or 90 mg (30 mg each) peptide/IFA

Four i.m. injections (weeks 0, 4, 8, and 20)

-Monitoring over 24 weeks

T cell proliferation responses and antibodies to each peptide

Delayed type hypersensitivity (DTH) responses to peptides

Clinical (joint pain and swelling scores, Health Assessment

and ACR scores)

Study Results

-Safety

TCR peptide immunization appeared to be safe and well

tolerated

3/27 serious adverse events were possibly related to study

treatment with 90 mg 40 mer

-Immunological responses

Higher proliferation responses observed in both dose groups

compared to controls

Responses were generally moderate (SI , 10) and short term

Patients with SI’s . 10 showed higher clinical responses

(7/10 . ACR30)

DTH responses to peptides sporadic

No antibody responses to peptides

-Clinical responses

Significant ACR20 response in 20 mer 30mg group versus

control at week 16

Clinically meaningful ACR20 improvement in 20 mer 90 mg

group at week 12

Clinically meaningful ACR20 improvement in 20 mer 30 mg

group at week 24

Clinically meaningful ACR20 improvement in 40 mer 90 mg

group at week 24

Significant response to 20 mers (30 mg and 90 mg) in patients

with early disease

 

Conclusions

-30 mg 20 mers and 90 mg 40 mers demonstrated significant

therapeutic effects

-40 mer peptides appeared to be more immunogenic than 20 mers

-Improvements in both strength and duration of immunological

responses should increase clinical responses

-Subgroups of patients showing ACR50 responses and those

showing ,ACR10 responses show potential of approach but need

for improved vaccines

-Monthly injections and enrollment of patients with disease less than

10 years may improve clinical outcome

 

Immune Response BioPharma, Inc.'s proprietary technology seeks to identify these 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.

Rationale: The observation of elevated expression and clonality of certain T cell receptors (TCR) in the rheumatoid synovium has led to clinical trials of TCR peptide vaccines for the treatment of 
rheumatoid arthritis (RA). IR501 Therapeutic Vaccine (IR501) consists of a combination of three, 17-20 amino acid peptides derived from TCRs (Vb17, Vb14 and Vb3) emulsified in incomplete Freunds adjuvant (IFA). A prior phase II study of IR501 in RA ) has shown it to be safe, well tolerated and effective. IR703
Therapeutic Vaccine (IR703) consists of three, 40 amino acid peptides which encompass the IR501 peptides. We report here the results of a double-blind placebo controlled phase IIb trial of IR501 and IR703 Therapeutic Vaccines in RA.

Methods: 340 patients with active RA were randomly assigned to five treatment groups: IR501: 30 mg; 90 mg; IR703: 30 mg; 90 mg; or IFA control. IM injections were given at weeks 0, 4, 8 and 20. Patients were assessed monthly for 24 weeks.

Results:Using ACR ³ 20% criteria, a statistically significant clinical response was found in the IR501 30 mg group compared with placebo (34% vs 18%, p< 0.05) at 16 weeks. The IR501 90 mg and IR703 90 mg groups also demonstrated significant improvement but did not reach statistical significance. Patients receiving 7.5 mg prednisone daily showed greater treatment effect. Patients with disease duration 3 years treated with IR501 30 mg and IR703 90 mg showed a statistically significant treatment effect at endpoint (50%, 50% vs 8%). In all but the IFA and IR703 30 mg treatment groups, improvement was seen after the initial 3 injections, but waned by week 20. In the IR501 30 mg and IR703 90 mg groups, dosing at week 20 boosted the clinical response.

Conclusions: These data suggest that IR501 and IR703 are safe, well tolerated and effective treatments for RA, particularly in early disease and in patients on physiologic low doses of prednisone. Enhancement of the clinical response may require monthly injections. These observations require confirmation in future 
clinical trials.

The double-blind trial 
enrolled 340 patients who received either 30 > micrograms (n=67)
or 90 micrograms (n=68) of IR501 Therapeutic Vaccine  or 30 micrograms (n=73) or 90
micrograms (n=66) of IR703 Therapeutic  Vaccine or adjuvant alone (n=65) as a control. Treatments were  administered as a single 1.0 mL intramuscular injection at Weeks 0, 4,  8, and 20, and patients were followed for 24 weeks.  The results of the trial suggest that the treatment may be safe and well > tolerated. Patients receiving both doses of IR501 and the higher dose of  IR703 appeared to have clinically meaningful improvement in their  disease condition after three injections. A statistically significant  (p patients with improvement in their disease condition was observed after  the third injection of IR501 Therapeutic Vaccine using the ACR 20  criteria for improvement.
 
 

 

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