The Immune Response Corporation Announces Publication of Phase 2 Trial Results For Rheumatoid Arthritis Treatment
PR Newswire - November 24, 1998 08:17
CARLSBAD, Calif., Nov. 24 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR) announced today the publication of results from a Phase 2 double-blind, placebo-controlled trial completed last year, using IR501 Therapeutic Vaccine. This immune-based, T cell receptor (TCR) peptide therapy was used to treat 99 patients with active rheumatoid arthritis. The results appear in a paper entitled "T Cell Receptor Peptide Vaccination in Rheumatoid Arthritis: A Placebo-Controlled Trial Using a Combination of Vb3, Vb14, and Vb 17," which was published in the journal ARTHRITIS & RHEUMATISM (Volume 41, Number 11, November 1998). The trial results suggest that patients receiving intramuscular injections of IR501 Therapeutic Vaccine (IR501) combined with Incomplete Freund's Adjuvant (IFA) showed statistically significant improvement when compared with patients receiving only IFA.
During the study, 31 patients received 90 mg of IR501, 35 patients received 300 mg of IR501, and 33 patients received IFA alone as a control. The study medication and placebo were administered as a single intramuscular injection (1 ml) at weeks 0, 4, 8, and 20. In conservative efficacy analyses, based on the American College of Rheumatology 20% improvement criteria, the 90-mg dosage group showed a significant decrease in disease symptoms, including swollen joints and arthritis-related pain, compared with control patients at the 20-week time point. Larry Moreland, M.D., principal investigator, noted: "The observation that the 90-mg dosage group showed a statistically significant treatment effect in the conservative analysis warrants additional studies to further investigate the potential usefulness of this therapy as a treatment for rheumatoid arthritis." As a follow-up to the Phase 2 trial that is the subject of this publication, the Company has recently completed a Phase 2b trial using the IR501 Therapeutic Vaccine and anticipates releasing the results by the end of 1998.
The Immune Response Corporation, a biopharmaceutical company based in Carlsbad, California, develops immune-based therapies to induce specific T cell responses for the treatment of HIV, autoimmune diseases, and cancer. The Company is conducting clinical trials on immune-based therapies for HIV, rheumatoid arthritis, psoriasis, multiple sclerosis, colon cancer, and brain cancer, and preclinical studies for melanoma and prostate cancers. In addition, the Company is developing a delivery technology that enables intravenously-injected genes to target the liver. This gene therapy program currently includes preclinical studies for the treatment of hemophilia and hepatitis.
This news release contains forward-looking statements. Actual results may vary materially from those expected due to a variety of risk factors, including the uncertainty of successful completion of clinical trials, and those risks set forth from time to time in the Immune Response Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended December 31, 1997. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
SOURCE The Immune Response Corporation
/CONTACT: Paula Margulies, The Immune Response Corporation, 760-603-3321/
/Company News On-Call: prnewswire.com or fax,
800-758-5804, ext. 434675/
/Web site: imnr.com
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