Anergen Announces IND Filing for Rheumatoid Arthritis
Candidate, AnergiX(TM)
Milestone in Collaboration With N.V. Organon
REDWOOD CITY, Calif., March 17 /PRNewswire/ -- Anergen, Inc. (Nasdaq: ANRG - news)
announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug
Administration (FDA) to commence clinical evaluation of AnergiX for treatment of rheumatoid
arthritis (RA). The company anticipates that the Phase I trial will begin in approximately 30 days.
The filing of the IND for AnergiX represents a milestone in Anergen's collaboration with N.V.
Organon, of Oss, The Netherlands. The drug combines an Organon peptide derived from HCgp39,
human cartilage-derived glycoprotein, with Anergen's proprietary AnergiX technology. AnergiX
products are designed to selectively inactivate T cells that are causing the inflammatory autoimmune
process, without inducing generalized suppression of the immune system. AnergiX for RA will be the
second AnergiX drug in clinical trials. The first is AnergiX for multiple sclerosis, which is currently in a
Phase I trial. Anergen expects to complete that trial later in 1998.
The Phase I trial in RA will be conducted at eight clinical centers in the U.S. and will enroll over thirty
patients who have long standing rheumatoid arthritis and who are concomitantly taking methotrexate.
Safety, tolerability and biological effects of AnergiX in RA will be evaluated. Secondary objectives
include pharmacokinetic data and initial assessments of clinical activity.
''The IND submission expands the depth and value of our autoimmune therapeutic programs, and
represents an important validation of our AnergiX technology platform,'' Barry M. Sherman, M.D.,
President and CEO, said. ''The company has established a strong intellectual property position
around this technology, which should bring value to our partners at Organon, as well as Anergen
shareholders.''
Dr. Sherman noted that this is the Company's second clinical entry into development of
genomics-based treatments for rheumatoid arthritis. The first drug, AnervaX(TM), recently
completed a Phase IIa clinical trial. The study found that administration of the therapeutic peptide
vaccine is safe and yields persistent clinical benefit in RA patients. Anergen is planning to initiate an
additional Phase II trial of AnervaX as soon as possible.
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.
N.V. Organon is one of the pharmaceutical business units of Akzo Nobel. Akzo Nobel,
headquartered in Arnhem, the Netherlands, is a market-driven and technology based company,
serving customers throughout the world with healthcare products, coatings, chemicals, and fibers.
The company employs 70,000 people and has activities in more than 60 countries. In 1997,
consolidated sales aggregated NGL 24.1 billion.
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.
SOURCE: Anergen, Inc.
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........................ Bob |
