- 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 patients -
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 (IVSR-UC).
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 clinical activity.
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 reported.
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 patients."
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
include:
o 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.
o 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.
o 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 IVSR-UC.
About DDW
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 http://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
http://www.pdl.com.
Forward-looking Statement
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
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 trademark and
RESTORE is considered a trademark of PDL BioPharma, Inc.
SOURCE PDL BioPharma, Inc.
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Related links:
http://www.pdl.com/
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.
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