- Preliminary data suggest Nuvion shows clinical activity in pretreated
moderate-to-severe Crohn's disease patients -
- Additional research data support potential for Nuvion in ulcerative colitis
FREMONT, Calif., May 24 /PRNewswire-FirstCall/ -- PDL BioPharma, Inc.
(PDL) (Nasdaq: PDLI) today announced that new data from studies of Nuvion(R)
(visilizumab) in Crohn's disease (CD) and ulcerative colitis (UC) were
presented at the annual Digestive Disease Week (DDW) conference this week. In
addition to the first presentation of preliminary clinical data evaluating
Nuvion in moderate-to-severe inflammatory, non-penetrating Crohn's disease
(CD), investigators also presented research data that further characterize
Nuvion's potential mechanism of action and support the continued investigation
of Nuvion in patients with intravenous steroid-refractory ulcerative colitis
Nuvion is a humanized monoclonal antibody that binds to CD3, a protein on
the surface of T cells. It is under investigation as a potential treatment
for various autoimmune diseases such as inflammatory bowel disease. DDW is
the largest meeting in the world for gastroenterologists and is taking place
from May 20 to 25 in Los Angeles, Calif.
Nuvion Shows Promise in Crohn's Disease
An oral presentation, "A Phase I Study: Visilizumab Therapy in Crohn's
Disease (CD) Patients Refractory to Infliximab Treatment" [Abstract #769]
given by Daan Hommes M.D., Head, Center for Inflammatory Bowel Diseases,
Academic Medical Center, Amsterdam, featured preliminary results from a multi-
center, open-label study of Nuvion in moderate to severe, inflammatory, non-
penetrating CD. The data suggested that two 10 mcg/kg doses of Nuvion could
be administered by IV bolus injection on consecutive days and appeared to have
In these patients with severe inflammatory CD, the coincident drop in the
inflammatory blood marker, C-reactive protein (CRP), suggested Nuvion may have
had a role in symptom improvement.
"Initial results from this study showed that Nuvion appeared to improve
Crohn's disease symptoms," Dr. Hommes said. "These results suggest that, in
addition to its potential as a treatment alternative for patients with severe
to fulminant ulcerative colitis, Nuvion merits further study as a potential
treatment for moderate-to-severe Crohn's disease patients, particularly those
who failed prior infliximab treatment."
Ten of the 14 patients reported a clinical response by Day 59, as
determined by a drop in the Crohn's Disease Activity Index (CDAI) score of 100
points. Five of the patients achieved a complete remission, as defined by a
CDAI score of 150 or less, during the 59 days. Of note, two patients who
never responded, as well as seven patients who lost their response to
infliximab, responded to Nuvion.
The severity, incidence and drug relatedness of the adverse events were
similar to what has been seen in UC patients who had received the same dose of
Nuvion (10 mcg/kg). Specifically, a transient decline in T cells and mild-to-
moderate symptoms of cytokine release syndrome (CRS) were reported in the
majority of patients. In addition, a transient elevation of transaminases was
observed in 10 of 14 patients within days following the infusions. No
lymphoproliferative, malignant or life-threatening adverse events were
Steven Benner, M.D., Senior Vice President and Chief Medical Officer, PDL,
said, "We are encouraged by the growing body of clinical evidence suggesting
Nuvion is a clinically active treatment for patients with CD as well as UC.
Based on the early results presented here, we are engaged in active
discussions with our advisors to determine next steps to further evaluate
Nuvion's potential in CD. Separately, we are continuing to enroll patients in
our pivotal Phase 2/3 RESTORE 1 trial, which is investigating Nuvion as a
potential treatment option in IVSR-UC patients. Pending a DSMB review later
this year, we hope to initiate a second pivotal Phase 3 study of Nuvion in UC
Research Data Support Nuvion Clinical Program
During the meeting, research analyses using patient samples from a now
completed Phase 1/2 study of Nuvion in IVSR-UC patients were the subject of
three poster presentations. Of the 76 patients treated with Nuvion and
evaluated in an interim analysis, 51 responded to treatment. Major findings
- Identification of biomarkers of Nuvion activity in IVSR-UC. The study
titled, "Biomarkers for Visilizumab Therapy of Intravenous Steroid
Refractory Ulcerative Colitis (IVSR_UC)" [Abstract S1322 - Sunday,
May 21], showed higher levels of CD8+ T-cell counts and serum IP-10
levels in responders compared with non-responders long after Nuvion had
cleared the circulation, suggesting these biological activities could
potentially be used as biomarkers of Nuvion activity in IVSR-UC.
- Histological improvement in Nuvion-treated IVSR-UC patients. The study
titled, "Visilizumab Treatment Promotes Morphological Recovery, Reduces
Inflammatory Markers and Affects T Cell Subsets In Mucosa of Ulcerative
Colitis Patients" [Abstract S1332 - Sunday, May 21], presented an
evaluation of tissue biopsies of the intestinal mucosa pre- and
post-treatment with Nuvion. A decrease in disease activity and a
reduction of inflammatory markers were seen in these biopsy samples.
Nine of 11 clinical responders showed histological improvement.
Evidence of mucosal healing will also be presented.
- CD8+ regulatory T-cell activity. The study titled, "Clinical Responses
to Visilizumab in Intravenous Steroid Refractory Ulcerative Colitis
(IVSR-UC) is Associated with Changes in CD8+ T Cells" [Abstract M1735 -
Monday, May 22] showed that in a lymphocyte culture experiment, Nuvion
induced CD8+ T-cell expansion and CD8+ regulatory T-cell activity.
Two additional posters of UC research conducted in collaboration with
researchers at the University of California at San Francisco and at
Cedars-Sinai Medical Center were presented. The study titled, "Visilizumab
Induces Apoptosis of Mucosal T cells from Ulcerative Colitis Patients In
Vitro" [Abstract S1690 - Sunday, May 21] showed that Nuvion in vitro induced
apoptosis of intestinal T cells isolated from moderate-to-severe UC patients
and not of T cells from the blood. The study titled, "Relationship of
Phenotype and Function of Blood T Lymphocytes to Disease Severity in
Ulcerative Colitis Patients" [Abstract 1201 - Wednesday, May 24] suggested
that treatment strategies for UC patients should focus on therapies that
promote mucosal healing and restoration of the mucosal immune balance rather
than general immunosuppression. Collectively, these data help advance our
understanding of how Nuvion may produce its clinical activity in patients with
DDW is the largest international gathering of physicians, researchers and
academics in the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American Association for
the Study of Liver Diseases, the American Gastroenterological Association, the
American Society for Gastrointestinal Endoscopy and the Society for Surgery of
the Alimentary Tract, DDW takes place May 20-25, 2006, at the Los Angeles
Convention Center. The meeting showcases approximately 5,000 abstracts and
hundreds of lectures on the latest advances in GI research, medicine and
technology. For more information, visit www.ddw.org.
About PDL BioPharma, Inc.
PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering,
developing and commercializing innovative therapies for severe or life-
threatening illnesses. The company currently markets and sells a portfolio of
leading products in the acute-care hospital setting in the United States and
Canada and generates royalties through licensing agreements with top-tier
biotechnology and pharmaceutical companies based on its pioneering antibody
humanization technology. Currently, PDL BioPharma's diverse late-stage
product pipeline includes six investigational compounds in Phase 2 or Phase 3
clinical development for hepatorenal syndrome, autoimmune and inflammatory
diseases, cardiovascular disorders and cancer. Further information on PDL
BioPharma is available at www.pdl.com.
The information in this press release should be considered accurate only
as of the date of the 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 may
contain "forward-looking statements" that are based on current expectations
and assumptions that are subject to risks and uncertainties. PDL's actual
results may differ materially from those in the forward-looking statements
because of various factors, risks and uncertainties. For further information
regarding factors, risks and uncertainties that may cause such differences,
please refer to PDL's filings 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 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 trademark and RESTORE is
considered a trademark of PDL BioPharma, Inc.
SOURCE PDL BioPharma, Inc.
CONTACT: Jean Suzuki, Product Communications, +1-510-574-1550, or
Jean.Suzuki@pdl.com, or Jim Goff, Investor Relations, +1-510-574-1421, or
James.Goff@pdl.com, both of PDL BioPharma, Inc.
/Web site: http://www.pdl.com