Anergen Reports Interim Phase II Trial Results of AnervaX(TM) Peptide Vaccine for Rheumatoid Arthritis
First Clinical Report of Therapeutic Benefit from a HLA-Specific Vaccine to Prevent T-Cell Activation
REDWOOD CITY, Calif., Nov. 10 /PRNewswire/ -- Anergen, Inc. (Nasdaq: ANRG - news) today announced that an interim analysis of an early Phase II trial of multiple injections of AnervaX(TM) therapeutic peptide vaccine determined that the pharmaceutical was safe, well tolerated, and provided persistent clinical benefit for symptoms of advanced rheumatoid arthritis (RA) in a substantial proportion of patients in the study. The results, the first ever reported with a human leucocyte antigen (HLA)-derived vaccine for the treatment of chronic autoimmune disease, were presented at the annual meeting of the American College of Rheumatology (ACR) in Washington, D.C.
''AnervaX was designed to act on rheumatoid arthritis at a much earlier step in the disease process than other therapies under evaluation,'' said Barry Sherman, M.D., President and CEO of Anergen. ''The drug appears to interfere with the, activation of disease-causing T-cells, not the consequences of their activity. We are particularly pleased that this approach shows clinical benefit, since intervening at an early point in the disease process is the key to successful treatment of many autoimmune conditions.''
''These results are the first clinical affirmation of the AnervaX technology platform developed by Anergen, and support further clinical evaluation of the vaccine for the treatment of rheumatoid arthritis and other autoimmune diseases,'' Dr. Sherman noted.
Rheumatoid arthritis, for which no satisfactory treatment exists, is one of the world's most debilitating chronic autoimmune diseases. Approximately 2.5 million Americans are estimated to suffer from the condition.
AnervaX is a synthetic 20 amino acid peptide designed to block the stimulation of T cells specifically involved in the rheumatoid arthritis disease process, interrupting its progression. The preliminary safety and tolerability of the vaccine had been established in an earlier Phase I study.
The design of this double-blinded, placebo-controlled trial was primarily intended to further evaluate safety and tolerability, and explore biological mechanisms. Fifty-three patients were enrolled in the study and received one of three dosage levels given on a six or eight week schedule on an outpatient basis.
''More than fifty percent of patients receiving injections at six week intervals had at least 20 percent improvement in standard measures of their rheumatoid arthritis, while 25 percent of patients in the eight week group had 50 percent improvement or more, as determined by the clinical guidelines of the ACR,'' noted Michael Shulman, M.D., Vice President of Clinical Development and coauthor of the study. Improvements in the number of tender and swollen joints, as well as three of five other established criteria, are considered markers of clinical efficacy for experimental pharmaceuticals.
E. William St. Clair, M.D., the study's primary investigator and Associate Professor of Medicine, Division of Rheumatology, Allergy & Clinical Immunology at the Duke University Medical Center in Durham, NC, said that AnervaX vaccination in RA patients ''has demonstrated excellent safety to date in 56 patients receiving both primary and one to four booster injections. There was no evidence of generalized immunosuppression in either study.''
''We also found a trend towards decreased expression of HLA-DR on the surface of peripheral blood mononuclear cells in patients with clinical improvement, suggesting a possible biological mechanism to explain the observed clinical effects,'' he said.
Coauthors of the study included Stanley B. Cohen and Roy Fleischmann (Metroplex CRC-Dallas); Sicy Lee (Hospital for Joint Diseases, NY); Larry Moreland (University of Alabama - Birmingham); Nancy J. Olsen (Vanderbilt University); Parks W. Pratt (Dothan - Alabama); David Yocum (University of Arizona); Jeffrey Winkelhake and John Holcenberg (Anergen).
Anergen, Inc. is a biotechnology company focused on advancing the treatment of autoimmune diseases. The Company is developing proprietary biopharmaceutical compounds designed to selectively interrupt antigen presentation or inactivate T cells in the immune system that mediate the disease process. |
