To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Colloral Shows Potential In Rheumatoid Arthritis URL: http://www.pslgroup.com/dg/25F26.htm Doctor's Guide May 12, 1997
LEXINGTON, Mass., May 12, 1997 -- Preliminary results from two Phase II trials of Colloral(R) for rheumatoid arthritis demonstrate positive trends, although statistical significance was not demonstrated versus placebo. Based on these data and previous trials, AutoImmune Inc. believes that Colloral has therapeutic benefit, but may require further development before entering Phase III trials. The company will conduct additional analysis of the Colloral data before defining the next development steps for this product. A third Phase II trial comparing Colloral to an active control remains ongoing. Independent statisticians conducted an interim analysis of this study and recommended that the trial continue to completion. Preliminary analysis of the results should be available in July. In the first study, a dose refinement trial, patients received 5, 20, or 60 microgram (mcg) doses of the drug versus placebo. Only patients with rheumatoid arthritis for nine years or less were admitted to the study. The most favorable trends from baseline were observed with the 60 mcg dose. Colloral was safe and well tolerated by patients at all dose levels. The second Phase II trial was designed to determine the clinical impact of Colloral on patients abruptly withdrawn from methotrexate, a frequently used disease modifying anti-rheumatic drug (DMARD). Patients received either 20 mcg of Colloral or placebo, and were observed for six months. On an intent-to-treat basis, more patients had a positive response by the Paulus criteria in the Colloral group than the placebo group. Those patients who did not complete the primary protocol were allowed to resume DMARD therapy if their physicians deemed it necessary. Although more patients on Colloral than on placebo resumed DMARD treatment, patients who continued on Colloral without DMARDs showed a therapeutic benefit versus the matching placebo group. Colloral was again found to be safe and well tolerated. The presence of anti-type II collagen antibodies in patients at baseline was not a predictor of response to Colloral. Patients in the ongoing third Phase II trial are receiving either Colloral or the anti-inflammatory drug, hydroxychloroquine. The patients entered in this trial were failing non-steroidal therapy and had not previously been treated with DMARDs. AutoImmune Inc. is a biopharmaceutical company developing a new class of drug therapies for the treatment of autoimmune diseases. With highly focused human and capital resources, the Company is developing products based on the principle of oral tolerance. These orally administered products are targeted for the treatment of rheumatoid arthritis, autoimmune-mediated diabetes, transplant rejection and uveitis. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.