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COLLORAL® SCIENCE

Over $45 million dollars was spent on the development of Colloral® including safety, pilot, dosing and efficacy studies. Prominent rheumatologists with large clinical practices and/or major university affiliations ran all of the clinical trials. Every study was conducted according to the FDA's Good Clinical Practice Guidelines.

 

 

ARTHRITIS & RHEUMATISM

Vol. 41, No. 2, February 1998. pp 290-297
© 1998, American College of Rheumatology

TREATMENT OF RHEUMATOID ARTHRITIS WITH
ORAL TYPE II COLLAGEN

Results of a Multicenter, Double-Blind, Placebo-Controlled Trial

MARTHA L. BARNETF, JOEL M. KREMER, F. WILLIAM ST. CLAIR, DANIEL 0. CLEGG, DANIEL FURST, MICHAEL WEISMAN, MALCOLM J. F. FLETCHER, SCOTT CHASAN-TABER, EDUARDO FINGER, ALEJANDRO MORALES, CHRISTINE H. LE, and DAVID E. TRENTHAM

Objective. Oral administration of cartilage-derived type II collagen (CII) has been shown to ameliorate arthritis in animal models of joint inflammation, and preliminary studies have suggested that this novel therapy is clinically beneficial and safe in patients with rheumatoid arthritis (RA). The present study was undertaken to test the safety and efficacy of 4 different dosages of orally administered CII in patients with RA.
Methods. Two hundred seventy-four patients with active RA were enrolled at 6 different sites and randomized to receive placebo or 1 of 4 dosages (20, 100, 500, or 2,500µg/day) of oral CII for 24 weeks. Efficacy parameters were assessed monthly. Cumulative response rates (percentage of patients meeting the criteria for response at any time during the study) were analyzed utilizing 3 sets of composite criteria: the Paulus criteria, the American College of Rheumatology criteria for improvement in RA, and a requirement for =30% reduction in both swollen and tender joint counts.
Results. Eighty-three percent of patients completed 24 weeks of treatment. Numeric trends in favor of the 20µg/day treatment group were seen with all 3 cumulative composite measures. However, a statistically significant increase (P = 0.035) in response rate for the 20µg/day group versus placebo was detected using only the Paulus criteria. The presence of serum antibodies to CII at baseline was significantly associated with an increased likelihood of responding to treatment. No treatment-related adverse events were detected. The efficacy seen with the lowest dosage is consistent with the findings of animal studies and with known mechanisms of oral tolerance in which lower doses of orally administered autoantigens preferentially induce disease-suppressing regulatory cells.
Conclusion. Positive effects were observed with CII at the lowest dosage tested, and the presence of serum antibodies to CII at baseline may predict response to therapy. No side effects were associated with this novel therapeutic agent. Further controlled studies are required to assess the efficacy of this treatment approach.

ARTHRITIS & RHEUMATISM

Vol. 39, No. 4, April 1996, pp 623—628
© 1996, American College of Rheumatology

A PILOT TRIAL OF ORAL TYPE II COLLAGEN IN THE TREATMENT
OF JUVENILE RHEUMATOID ARTHRITIS

MARTHA L. BARNETT, DANIEL COMBITCHI, and DAVID E. TRENTHAM

Objective. To evaluate the efficacy of oral chicken type II collagen (CCII) in the treatment of juvenile rheumatoid arthritis (JRA).
Methods. Ten patients with active JRA were treated with CCII for 12 weeks. Efficacy parameters, which included swollen and tender joint count and score, grip strength, 50-foot walking time, duration of morning stiffness, and patient and physician global scores of disease severity, were assessed monthly.
Results. All patients completed the full course of therapy. Eight patients had reductions in both swollen and tender joint counts after 3 months of CCII. The mean changes from baseline in swollen and tender joint counts for the 8 responders at the end of the study were —61% and —54%, respectively. Mean values for other efficacy parameters also showed improvement from baseline. There were no adverse events that were considered to be treatment related.
Conclusion. Oral CCLI may be a safe and effective therapy for JRA, and its use in this disease warrants further investigation.

 

SCIENCE

24 September 1993, Volume 261, PP. 1727—1730

Effects of Oral Administration of Type II Collagen
on Rheumatoid Arthritis

David E. Trentham,* Roselynn A. Dynesius-Trentham, E. John Orav, Daniel Combitchi, Carlos Lorenzo, Kathryn Lea Sewell, David A. Hafler, and Howard L. Weiner

Rheumatoid arthritis is an inflammatory synovial disease thought to involve T cells reacting to an antigen within the joint. Type II collagen is the major protein in articular cartilage and is a potential autoantigen in this disease. Oral tolerization to autoantigens suppresses animal models of T cell—mediated autoimmune disease, including two models of rheumatoid arthritis. In this randomized, double-blind trial involving 60 patients with severe, active rheumatoid arthritis, a decrease in the number of swollen joints and tender joints occurred in subjects fed chicken type II collagen for 3 months but not in those that received a placebo. Four patients in the collagen group had complete remission of the disease. No side effects were evident. These data demonstrate clinical efficacy of an oral tolerization approach for rheumatoid arthritis.

 

Copyright © 1993 by the American Association for the Advancement of Science