Nuvion Antibody Led to a Sustained Response and Remission in Follow-up to
Phase 1 and Phase 1/2 studies and Was Adequately Tolerated in Patients with
IV Steroid-Refractory Ulcerative Colitis
FREMONT, Calif., May 22 /PRNewswire-FirstCall/ -- Data presented at the
Digestive Disease Week (DDW) meeting this week in Washington D.C. by Dr.
William Sandborn from the Mayo Clinic suggest that Nuvion (visilizumab), an
antibody in development as a treatment for intravenous steroid-refractory
ulcerative colitis (IVSR-UC), administered on day 1 and day 2, produced a
sustained clinical response up to 310 days and was adequately tolerated.
The results presented were from long-term follow up of 138 patients who had
received Nuvion in a Phase 1 and Phase 1/2 study as a treatment for
IVSR-UC, which contributes to the majority of an estimated 30,000 colectomy
procedures performed in the U.S. each year. In addition, early data also
will be presented at the meeting regarding the Nuvion antibody's potential
as a treatment for Crohn's disease.
"The data presented by Professor Sandborn further support our decision
to advance Nuvion into a Phase 3 program in patients with IV
steroid-refractory ulcerative colitis," said Mark McCamish, M.D., Ph.D.,
PDL's senior vice president and chief medical officer. "Patients with
severe ulcerative colitis face surgical intervention or colectomy, and
positive results from our Phase 3 program would lead to a welcomed
treatment for these difficult-to-treat patients who currently have very
limited non-surgical options."
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, with the aim of significantly reducing the
symptoms of the disease and potentially delaying or avoiding the need for
colectomy, or surgical removal of the colon. An estimated 60,000 colectomy
procedures are performed in the U.S. and Europe every year. In April, after
review of the current data from an external data monitoring committee, PDL
announced that it would advance the Nuvion antibody into a second pivotal
study in patients with IVSR-UC, the most severe form of this inflammatory
bowel disease that attacks the colon.
Summary of Results (Abstract T1279)
In the study presented by Dr. Sandborn, 138 subjects with IVSR-UC were
treated with visilizumab at 5, 7.5, 10, 12.5 or 15 mg/kg intravenously on
two consecutive days (Days 1 and 2). Eighty-nine (64.5%) of the 138
patients demonstrated a clinical response at day 30. Clinical response was
defined by using one of two standard measures to determine the severity of
the patient's ulcerative colitis.
Patients were followed for a median of 356 days, ranging from 21 to
792. During the follow-up period, 53% (73/138) received medical or surgical
rescue therapy. Only 28 (35%) of the Day 30 responders ended up undergoing
rescue therapy during subsequent observation. Encouraging new data
presented at DDW from this study show the median time to first rescue
therapy was 310 days. Forty-six (33%) patients underwent colectomy (colon
removal), either as first rescue therapy or subsequent to failed medical
rescue.
The Nuvion antibody was adequately tolerated, with 120 (87%) patients
experiencing transient, mild to moderate infusion reactions due to cytokine
release within the first three days of treatment. These symptoms were
minimized with pre-medication and hydration. A total of 17 (12%) patients
also experienced serious or opportunistic infections, including localized
mucocutaneous herpes and candida infections, but there were no disseminated
opportunistic infections. The Nuvion antibody also produced a transient
decline in T cells, which generally lasted less than 30 days.
Additional Nuvion Data Presentations
Two additional presentations at DDW support the potential of Nuvion as
a treatment for inflammatory bowel diseases:
-- On Monday, May 21, Lloyd F. Mayer, M.D., Professor and Chairman of the
Immunobiology Center, Professor of Medicine and Chief of the Divisions
of Clinical Immunology and Gastroenterology at the Mount Sinai School
of Medicine in New York, presented results of a study (Abstract M1679)
demonstrating that in in vitro culture experiment, the Nuvion antibody
induced expansion of CD8+ T cells, and the CD8+ T cells possessed
regulatory T cell activity. If confirmed in human studies, this
mechanism may contribute to the observed long-term response to the
Nuvion antibody in some patients with IVSR-UC, Dr. Mayer concluded.
-- On Wednesday, May 23, Daniel C. Baumgart M.D., Charite Medical Center,
Virchow Hospital, Berlin, Germany, will deliver an oral presentation of
data supporting the efficacy and safety of the Nuvion antibody in
patients with moderate-to-severe, refractory Crohn's disease (Abstract
1032). The data from this study are intriguing, and PDL is assessing
options for further study in this patient population.
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 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, results obtained in the Phase 1 and Phase 1/2 studies of the
Nuvion (visilizumab) antibody may not be predictive of results that may be
obtained in the additional evaluations that would be necessary to
demonstrate visilizumab to be safe and effective in the treatment of
IVSR-UC, nor can there be assurance that PDL will initiate or complete the
subsequent clinical trials and evaluations that 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, jean.suzuki@pdl.com; or Kathleen Rinehart,
Corporate Communications, +1-510- 574-1480,
kathleen.rinehart@pdl.com, both of PDL BioPharma, Inc.
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