Statement From the Lupus Foundation of America Regarding the Release of Top-Line Results From a Study of Rituxan for the Treatment of Lupus

WASHINGTON, April 29, 2008/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.

"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 battle lupus with their families every day have waited long enough."

Lupus is the result of an unbalanced immune system that can become destructive to any major organ or tissue in the body. Lupus is unpredictable and potentially fatal, yet no satisfactory treatment or cure exists. Its health consequences may include heart attacks, strokes, seizures, or sudden organ failure. Current treatments are immune-suppressing agents, which have toxic side effects, increasing risks for infections and other bodily damage. The LFA estimates that more than 1.5 million Americans have some form of lupus.

Although lupus can strike any person at any age, nine of 10 people with lupus are women of childbearing age (ages 15-45). Lupus is two to three times more common among women of color, including African Americans, Hispanics, Native Americans and Asians.

The LFA is the nation's foremost nonprofit voluntary health organization dedicated to finding the causes of and cure for lupus, and providing support, services, and hope to all people affected by lupus. The LFA and its network of nearly 300 chapters, branches, and support groups conduct programs of research, education, and advocacy.

CONTACT: Sandra C. Raymond of the Lupus Foundation of America,+1-202-349-1144, raymond@lupus.org

Web site: http://www.lupus.org/

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Posted: April 2008

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