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Biotech / Medical : ANRG -- Anergen -- new CEO big chance ? -- Ignore unavailable to you. Want to Upgrade?

To: Douglas who wrote (80)	3/17/1998 8:26:00 AM
From: bob jaremsek	Read Replies (1) \| Respond to of 123

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. __________________________________________________________________ ........................ Bob