Sunday November 14, 8:31 am Eastern Time
Company Press Release
Clinical Data On Two Amgen Rheumatoid Arthritis
Product Candidates Presented at ACR
BOSTON--(BUSINESS WIRE)--Nov. 14, 1999--Amgen (NASDAQ:AMGN - news)
today announced the release of data on an investigational drug that has the potential to
impact rheumatoid arthritis at its most basic biological levels, at the annual meeting of the American College of Rheumatology.
Data from a 419-patient, double blind, placebo-controlled trial of Amgen's interleukin-1 receptor antagonist, Kineret(tm)
(anakinra, IL-1ra), combined with methotrexate in patients with rheumatoid arthritis showed that 42 percent of the
Kineret/methotrexate patients at a Kineret dose of 1 mg/kg/day sc achieved a meaningful clinical response, compared to 23
percent of patients receiving methotrexate alone. Clinical response was measured by the ACR 20 composite index. These data
suggest that the combination produced a significant improvement in signs and symptoms associated with active disease. The
most frequently reported adverse event was injection site reaction.
As previously reported, the potential of Kineret to reduce both inflammation and bone and cartilage destruction, thereby
slowing disease progression, suggests that the molecule may provide a meaningful benefit to patients with rheumatoid arthritis.
IL-1 is a mediator of joint inflammation and destruction. The body's naturally-occurring IL-1ra directly and selectively blocks
the deleterious effects of IL-1, a substance released as part of the disease process in people with rheumatoid arthritis.
TNF(alpha), or tumor necrosis factor (alpha), also plays a major role in joint inflammation and appears to be blocked by a
second investigational drug that Amgen is developing, referred to as Soluble Tumor Necrosis Factor Receptor type I, or
sTNF-RI.
In the first human trial of sTNF-RI, the drug appeared to be safe and well-tolerated in people with moderate to severe disease.
No serious adverse events were seen, and those adverse events seen were similar among placebo and all treatment groups. A
total of three abstracts on this phase 1 study were presented at the ACR meeting. A phase 2 clinical trial in people with
rheumatoid arthritis is underway.
Rheumatoid arthritis is a common form of arthritis that causes inflammation in the lining of the joints and other organs. It can
cause damage to bone, cartilage, tendons and ligaments. This form of arthritis tends to last for many years and typically affects
many different joints.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets cost-effective human
therapeutics based on advances in cellular and molecular biology.
EDITOR'S NOTE: An electronic version of this news release may be accessed via our web site at www.Amgen.com. Visit the
Corporate Center and click on Amgen News. Journalists and media representatives may sign up to receive all news releases
electronically at time of announcement by filling out a short form in the Amgen News section of the web site.
Contact:
Amgen, Thousand Oaks
David Kaye, 805/447-6692 (media)
Cary Rosansky, 805/447-4634 (investors) |
