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PDL BioPharma, Inc. Presents Preclinical Data On Novel Monoclonal Antibody For Multiple Myeloma At The American Society of Hematology Annual Meeting

Published: Dec 12, 2006

FREMONT, Calif., Dec. 11 /PRNewswire-FirstCall/ -- PDL BioPharma, Inc. 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 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 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.

PDL BioPharma, Inc.

CONTACT: Ami Knoefler, Corporate and Investor Relations, +1-510-284-8851or 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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