Four presentations highlight in vitro and in vivo studies of HuLuc63 and
support advancement into the clinic
Phase 1 clinical trial in patients with relapsed/refractory multiple
myeloma underway
FREMONT, Calif., Dec. 11 /PRNewswire-FirstCall/ -- PDL BioPharma, Inc.
(Nasdaq: PDLI) today announced that preclinical data on HuLuc63, a
humanized monoclonal antibody product targeting human CS1, were presented
today at the 48th Annual Meeting of the American Society of Hematology
(ASH) taking place from December 9 to 12 in Orlando, Florida. Results
presented in one oral presentation and three poster presentations summarize
the data that supported the advancement of HuLuc63 into a Phase 1 clinical
trial, which is currently enrolling patients in the United States (U.S.).
HuLuc63 is a humanized monoclonal antibody that binds to human CS1, a
cell-surface glycoprotein that is highly expressed on multiple myeloma
cells but minimally expressed on normal cells.
"We are very excited about the preclinical results we have seen with
HuLuc63 in myeloma cells, particularly because the antibody's target, CS1,
is a truly novel target that I believe has not been explored in the
treatment of myeloma to date," said Mohamad Hussein, M.D., Clinical
Director, Leader, Myeloma Clinical Research Malignant Hematology Division,
H. Lee Moffitt Cancer Center and Research Institute. "We are hopeful that
the recently initiated Phase 1 trial will yield results that support what
we have seen in preclinical models, and will help move this exciting
compound forward as a potential new antibody treatment for these patients.
Multiple myeloma patients, in general and especially those who are eligible
for this trial, have an incurable disease associated with high morbidity
and mortality, representing the greatest unmet medical need in treating
multiple myeloma patients with active disease."
An oral presentation titled, "CS1 is expressed on myeloma cells from
early stage, late stage, and drug-treated multiple myeloma patients, and is
selectively targeted by the HuLuc63 antibody" [abstract # 660], given by
collaborators at the University of Arkansas, showed that myeloma cells
express high levels of CS1 regardless of the stage of disease.
Additionally, when these myeloma cells were treated in vitro with HuLuc63,
the antibody appeared to enhance the lysis or killing of the cells.
Three posters that further characterize HuLuc63's proposed mechanism of
action and target expression were also presented today:
-- Eradication of tumors in preclinical models of multiple myeloma by
anti-CS1 monoclonal antibody HuLuc63: mechanism of action studies
[abstract # 3503]
-- Killing of drug-sensitive and resistant myeloma cells and disruption of
their bone marrow stroma interaction by HuLuc63, a novel humanized
anti-CS1 monoclonal antibody [abstract # 3470]
-- CS1: a potential new therapeutic target for the treatment of multiple
myeloma [abstract # 3457]
The Phase 1 trial of HuLuc63 in patients with relapsed/refractory
multiple myeloma is currently underway. The trial is being conducted in the
U.S. and is designed to identify the maximum tolerable dose of HuLuc63, in
addition to evaluating preliminary safety and clinical activity.
"PDL researchers first identified the CS1 target and its biology
related to multiple myeloma, and are now working with colleagues at the top
myeloma institutions in this country to further characterize HuLuc63's
mechanism of action and advance the clinical program," said Richard Murray,
Ph.D., Chief Scientific and Technical Officer, PDL BioPharma. "The HuLuc63
program is representative of our commitment to the discovery and
development of novel approaches to therapeutic intervention for unmet
medical conditions in oncology and inflammation."
About Multiple Myeloma
Multiple myeloma is the second most common hematological malignancy in
the U.S., accounting for about 10 percent of all hematologic malignancies
and 1 percent of all malignancies. In 2005, approximately 50,000 Americans
were reported to have multiple myeloma, and about 16,000 Americans were
newly diagnosed with the disease. More than 11,000 patient deaths due to
multiple myeloma were reported in the U.S. in 2005. The average 5-year
survival is 32 percent and the average 10-year survival is 3 percent.
Multiple myeloma is characterized by malignant plasma cells that form
tumors in the bone marrow. These plasma cell tumors can spread throughout
the bone marrow, thereby disrupting the production of red blood cells and
platelets, which normally occur in the bone marrow. Excessive amounts of
malignant plasma cells may also decrease the number of white blood cells,
which are important in fighting off infections.
About PDL BioPharma
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's
diverse product pipeline includes investigational compounds in clinical
development for inflammation and autoimmune diseases, cardiovascular
disorders and cancer. The company's research platform is focused on the
discovery and development of antibodies for the treatment of cancer and
autoimmune diseases. For more information, please see PDL's website at
http://www.pdl.com.
Forward-looking Statements
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.
The actual results may differ materially from those in the forward-looking
statements because of various factors, risks and uncertainties. In
particular, results of in vitro and in vivo studies may not be predictive
of results that may be obtained in clinical trials and additional
evaluations would be necessary to demonstrate HuLuc63 to be safe and
effective in the treatment of advanced multiple myeloma. In addition, there
can be no assurance that the Phase 1 trial will be successfully completed
or that PDL will initiate subsequent clinical trials of HuLuc63 after the
planned Phase 1 trial. 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.
PDL BioPharma and the PDL BioPharma logo are considered trademarks of
PDL BioPharma, Inc.
SOURCE PDL BioPharma, Inc.
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Related links:
http://www.pdl.com
CONTACT:
Ami Knoefler, Corporate and Investor
Relations, +1-510-284-8851 or ami.knoefler@pdl.com, or Jean
Suzuki, Corporate Relations, +1-510-574-1550 or
jean.suzuki@pdl.com, both of PDL BioPharma, Inc.
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