FREMONT, Calif., April 26 /PRNewswire-FirstCall/ -- PDL BioPharma, Inc.
(PDL) (Nasdaq: PDLI) today announced that the company will advance its
Nuvion(R) (visilizumab) antibody in patients with intravenous steroid-
refractory ulcerative colitis (IVSR-UC) into a phase 3 program. Advancement
of the program follows guidance from an independent external Data
Monitoring Committee (DMC) based on a planned safety and futility
assessment of data from 60 patients enrolled in an ongoing phase 2/3
clinical trial of the Nuvion antibody in patients with IVSR-UC. As a
result, the company will continue with enrollment in this ongoing phase 2/3
trial, known as RESTORE 1, while starting a second pivotal trial in the
same patient population, known as RESTORE 2.
"We are pleased to continue development of Nuvion in this important
indication," said Mark A. McCamish, M.D., Ph.D., senior vice president and
chief medical officer, PDL BioPharma. "There is a significant unmet medical
need in patients with IVSR-UC, as patients at this stage of the disease
have exhausted other treatment options and are facing surgery to remove
their colons."
Nuvion is a humanized monoclonal antibody designed to target and
modulate the action of T cells, the cells believed to cause inflammation
leading to ulcerative colitis (UC), with the aim of significantly reducing
the symptoms of the disease and potentially delaying the need for
colectomy, or surgical removal of the colon. An estimated 60,000 UC
patients a year in both the U.S. and Europe undergo colectomies.
Long-term follow-up data from PDL's earlier Nuvion studies in this
patient population will be presented at the upcoming Digestive Disease Week
congress, which will be held from May 19 - 24, 2007 in Washington, D.C.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease caused by an abnormality in the
body's immune system that leads to inflammation and ulceration of the
innermost lining of the colon (or large intestine), which can cause
diarrhea, pain and bleeding. In severe cases, individuals may have diarrhea
10 to 20 times a day, which may lead to dehydration, fever, hospitalization
and the need for blood transfusions. More than one million people worldwide
suffer from UC, which primarily affects men and women in their 30s, but can
occur at any age. An estimated 25 to 40 percent of these patients
eventually fail to respond to standard medical therapy of oral and
intravenous steroids.
About PDL BioPharma
PDL BioPharma, Inc. is a biopharmaceutical company focused on
discovering, developing and commercializing innovative therapies for severe
or life-threatening illnesses. Commercially focused in the acute-care
hospital setting, PDL markets and sells its portfolio of leading products
in the United States and Canada. A pioneer of antibody humanization
technology, PDL promotes this technology through licensing agreements and
clinical development of its own diverse pipeline of investigational
compounds. PDL's research platform centers on the discovery and development
of antibodies to treat cancer and autoimmune diseases. For more
information, please visit http://www.pdl.com.
Forward-looking Statements
The information in this press release should be considered accurate
only as of the date of this press release. PDL has no intention of updating
and specifically disclaims any duty to update the information in this press
release for any reason, except as required by law, even as new information
becomes available or other events occur in the future. This press release
contains "forward-looking statements" that are based on current
expectations and assumptions that are subject to risks and uncertainties.
The actual results may differ materially from those in the forward-looking
statements because of various factors, risks and uncertainties. In
particular, the advancement of the Nuvion program following the guidance of
the DMC may not be predictive of continued advancement of the program or
predictive of results that would need to be obtained in the additional
evaluations and studies that would be necessary to demonstrate the Nuvion
antibody to be safe and effective in the treatment of patients with
IVSR-UC. There can also be no assurance that PDL will initiate or complete
the RESTORE 2 trial or any other subsequent clinical trials which would be
necessary to support marketing approval of the Nuvion antibody by the
United States Food and Drug Administration. For further information
regarding factors, risks and uncertainties that may cause such differences,
please refer to the filings PDL has made with the Securities and Exchange
Commission, including the "Risk Factors" sections of PDL's Quarterly and
Annual Reports, copies of which may be obtained at the "Investors" section
on PDL's website at http://www.pdl.com. All forward- looking statements in this
press release are qualified in their entirety by this cautionary statement.
NOTE: PDL BioPharma and the PDL BioPharma logo are considered
trademarks of PDL BioPharma, Inc. Nuvion is a registered U.S. trademark of
PDL BioPharma, Inc.
SOURCE PDL BioPharma, Inc.
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Related links:
http://www.pdl.com/
CONTACT:
Jean Suzuki, Investor Relations,
+1-510-574-1550, or jean.suzuki@pdl.com, or Kathleen Rinehart,
Corporate Communications, +1-510-574-1480, or
kathleen.rinehart@pdl.com, both of PDL BioPharma
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