To: tuck who wrote (205 ) 5/14/2002 4:55:16 PM From: nigel bates Read Replies (1) | Respond to of 407 Protein Design Labs Begins Phase I Trial of Remitogen(TM) in Cancer Patients With Solid Tumors FREMONT, Calif., May 14 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI - News) today said that it has initiated a Phase I clinical trial to evaluate the safety and pharmacokinetics of its humanized antibody Remitogen (apolizumab) in cancer patients with solid tumors. The Phase I clinical trial is an open-label, dose escalation trial to be conducted in up to 42 patients at two centers in the United States. The population treated will include patients with relapsed or refractory solid tumors expressing the 1D10 antigen for whom no standard treatment exists. Patients enrolled in the trial will receive a single dose of apolizumab via intravenous infusion once weekly for four consecutive weeks. Those whose disease has not progressed at their first evaluation will be eligible to receive a second course of treatment. "We are pleased to expand the possible indications for apolizumab by beginning to assess its potential in solid tumors," said Cary L. Queen, Ph.D., Senior Vice President, PDL. "We believe it could become an important element in our efforts to build an oncology franchise at PDL, which could potentially include other of our proprietary product candidates such as Zamyl(TM), which has completed a Phase III study in acute myeloid leukemia, and Nuvion®, which recently entered Phase II testing in steroid-resistant graft-versus-host disease." Apolizumab is a humanized antibody that binds to the 1D10 antigen, an HLA-DR determinant found on many pre-B and B-cell lymphomas as well as on multiple solid tumors, including breast, colon, kidney, ovary and stomach. The 1D10 antigen also is present on cancer cells from acute and chronic lymphocytic leukemia patients. A number of clinical trials of apolizumab are ongoing in various cancer indications, including a Phase II clinical trial in non-Hodgkin's lymphoma, a Phase I trial in combination with Rituxan® in patients with relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia, and a Phase I trial in chronic lymphocytic leukemia/small lymphocytic lymphoma and adult acute lymphocytic leukemia. The foregoing contains forward-looking statements involving risks and uncertainties and PDL's actual results may differ materially from those in the forward-looking statements. Factors that may cause such differences are discussed in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2002, and in its Annual Report on Form 10-K for the year ended December 31, 2001, as amended. In particular, there can be no assurance that PDL will complete the clinical trials of apolizumab or other of its oncology product candidates described here, or that the data from those trials would be indicative of results to be obtained in the more extensive evaluations which would be required to show the antibodies to be safe and effective, or that would be adequate to seek or obtain regulatory clearance. Protein Design Labs, Inc. is a leader in the development of humanized antibodies to prevent or treat various disease conditions. PDL currently has antibodies under development for autoimmune and inflammatory conditions, asthma and cancer. PDL holds fundamental patents for its antibody humanization technology. For further information, visit www.pdl.com...