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."
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