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Statement From the Lupus Foundation of America Regarding the Release of Top-Line Results From a Study of Rituxan for the Treatment of Lupus
Date:4/29/2008

WASHINGTON, April 29 /PRNewswire-USNewswire/ -- Preliminary results were released today from a late-stage clinical trial of Rituxan (rituximab) for the treatment of lupus. The study did not meet its primary or secondary endpoints of clinically reducing the severity of SLE (systemic lupus erythematosus) in people with moderate disease.

The findings are initial results from a Phase II/III study conducted by Genentech, Inc., known as the EXPLORER study. Rituxan is approved by the U.S. Food and Drug Administration for the treatment of non-Hodgkin's lymphoma, and was more recently approved, in combination with methotrexate, to treat rheumatoid arthritis. More detailed findings from the trial are expected to be presented at a medical conference this fall.

Following is a statement about the study results from Sandra C. Raymond, President & CEO of the Lupus Foundation of America:

"Demonstrating the impact of a treatment in a lupus clinical trial can be difficult, as lupus manifests itself differently in different people, and can increase and decrease in severity from one day to another. So while these new results are disappointing, they are not necessarily surprising.

"People with lupus have been waiting for a new treatment for nearly 45 years while suffering from this disabling and sometimes life-threatening disease. But it's important to remember that there are a variety of promising therapies in the near-term pipeline - including an ongoing study of Rituxan for the treatment of lupus nephritis (kidney disease). That study assesses Rituxan's potential in a focused subset of lupus patients with a highly objective outcome. Thus, we remain optimistic that we are coming ever closer to new and better treatments for lupus.

"Lupus patients have suffered without a new treatment for more than four decades. For this reason, we are grateful to the companies that are searching for new lupus treatments. The millions of people who bat
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SOURCE Lupus Foundation of America
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