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

Apr 29, 2008, 01:00 ET from Lupus Foundation of America

    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 battle lupus
 with their families every day have waited long enough."
     About Lupus
     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.
     About the Lupus Foundation of America
     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.

SOURCE Lupus Foundation of America