Anergen Reports Successful Completion of Phase IIa Trial of
Anervax(TM) Peptide Vaccine for Rheumatoid Arthritis
Anergen CEO Provides Company Update
REDWOOD CITY, Calif., March 5 /PRNewswire/ -- Anergen, Inc. (Nasdaq: ANRG - news) announced that the completed
analysis of an early Phase II trial in rheumatoid arthritis of AnervaX therapeutic peptide vaccine confirmed the conclusions of
an earlier interim review of the study.
''The final data analysis confirms that AnervaX is safe and results in important clinical improvement in patients with rheumatoid
arthritis in this study,'' said Barry Sherman, M.D., President and CEO of Anergen. ''AnervaX has the potential to safely arrest
the disease at a very early step in the autoimmune process. We plan to initiate an additional Phase II study as soon as
possible.''
The Phase IIa trial was primarily intended to evaluate safety, and define the effect of AnervaX on certain biological
mechanisms. AnervaX was evaluated in 53 subjects with active RA, whose joints were painful, tender and swollen despite
taking methotrexate with or without oral corticosteroids. The final analysis confirms and strengthens the interim analysis of data
from the trial which was presented at the annual meeting of the American College of Rheumatology in November 1997.
Administration of AnervaX was not associated with suppression of the immune system, a major complication of many
therapies for chronic autoimmune diseases.
Clinical improvement in signs and symptoms of RA observed in patients dosed at six week intervals was clearly superior to
that seen in the placebo group or those patients dosed at eight week intervals. Six weeks following the last injection, 7/16
patients (44%) had an improvement in their disease severity score of at least 20%, ranging from 21 to 42%, with a mean of
34%. Improvement in the number of painful and swollen joints is the major contributor to the composite index. In the six week
group there was a 46% improvement in the number of painful joints (p=.12) and a 50% improvement in the number of swollen
joints (p=.02). Persistent benefit was reflected in 7/20 (35%) patients who had greater than 20% improvement in ACR score,
12 weeks after the final dose.
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. Rheumatoid arthritis is one of the world's most prevalent and
destructive chronic autoimmune diseases. Approximately 2.5 million Americans suffer from the condition.
In an update for employees and investors, Dr. Sherman reported that along with the success seen with AnervaX, the Company
has made significant progress in preclinical development of AnergiX(TM) for rheumatoid arthritis and DiavaX(TM) for the
prevention of Type I diabetes. With the addition of new management strength, the Company is well positioned for the
achievement of key milestones in 1998.
''We now have robust clinical and preclinical programs directed against three major autoimmune diseases: multiple sclerosis,
rheumatoid arthritis and diabetes, '' noted Dr. Sherman. ''In addition to the Phase IIa data on AnervaX, the Phase I AnergiX
clinical study in multiple sclerosis progressed well, as did our preclinical with AnergiX in rheumatoid arthritis and DiavaX for
the prevention of Type I diabetes. These developments are the basis for Anergen's future growth.''
Key product development milestones for the company in 1998 are:
* The filing of an Investigational New Drug (IND) application with the
U.S. Food and Drug Administration (FDA) in the first quarter and
subsequent initiation of a Phase I study for AnergiX in rheumatoid
arthritis, in conjunction with our corporate partner, N.V. Organon.
* Initiation in the third quarter of the Phase IIb study of AnervaX for
rheumatoid arthritis.
* Completion of the AnergiX Phase I clinical study in multiple sclerosis
in the third quarter.
* IND filing for DiavaX in late 1998 or early 1999 for the treatment of
new onset Type I diabetes.
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.
Note: Certain statements in this press release about the Company's utilization of resources, product development activities,
clinical trials, and product pipelines, other than statements of historical fact, are forward looking statements, and are made
pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve risks
and uncertainties. The Company's actual results could differ materially from the results discussed in these forward looking
statements. Factors that could cause or contribute to such differences include dependence upon collaborative partners for the
advancement of the company's research and development activities, uncertainties related to preclinical and clinical trials,
government regulation; no assurance of obtaining product approvals, and future requirements for additional capital. These items
are discussed in the Company's Form 10-K filed for fiscal years 1996 and 1997 and the reports filed on Form 10-Q. |
