PDL BioPharma, Inc. announced today two presentations of data at medical conferences related to the company’s development-stage antibody products in multiple sclerosis and oncology
REDWOOD CITY, CA, USA | April 14, 2008 | PDL BioPharma, Inc. (NASDAQ: PDLI) announced today two presentations of data at medical conferences related to the company’s development-stage antibody products in multiple sclerosis and oncology. Details regarding each of the presentations are summarized below. Copies of the poster and plenary presentations will be available on PDL BioPharma’s website at the time of publication.
Daclizumab — Long-Term CHOICE Trial Follow-Up Data at AAN
Researchers will present 44-week follow-up data on the daclizumab phase 2 CHOICE trial in multiple sclerosis during a plenary session at the American Academy of Neurology (AAN) 60th Annual Meeting in Chicago on April 16.
Study: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Subcutaneous Daclizumab, a Humanized Anti-CD-25 Monoclonal Antibody, in Patients with Active, Relapsing Forms of Multiple Sclerosis – Week 44 Results Presenter: Michael Kaufman, M.D. Director of the Multiple Sclerosis Center at Carolinas Medical Center, representing the investigators
Where: The AAN annual meeting, McCormick Place West, Chicago
When: Plenary Session scheduled for 9:00 am CT April 16
Daclizumab is a humanized monoclonal antibody that binds to the IL-2 receptor on activated T cells, inhibiting the binding of IL-2 and the cascade of pro-inflammatory events contributing to organ transplant rejection and autoimmune-related diseases.
In October 2007, researchers presented positive 24-week follow-up data from the phase 2, randomized, double blind, placebo-controlled clinical study, known as the CHOICE trial. In patients with active MS, daclizumab used in combination with interferon beta therapy resulted in a substantial reduction in new/enlarged gadolinium contrast enhanced lesions compared to interferon beta therapy used in combination with a placebo. In general, the combination therapy was shown to be safe and well tolerated in the study.
Biogen Idec, PDL’s co-development partner, is currently enrolling patients in an additional study, the SELECT Trial, which evaluates daclizumab as a monotherapy for MS.
PDL192 — Poster Presentation at AACR
PDL presented pre-clinical data on its novel investigational drug, PDL192, on April 13 at the American Association for Cancer Research (AACR) Annual Meeting 2008, which takes place in San Diego, April 12-16.
Study: Anti-TweakR Antibodies Inhibit Tumor Growth In Vivo Through Dual Mechanisms Presenter: Patricia Culp, Ph.D, PDL BioPharma
Where: AACR Annual Meeting, San Diego Convention Center, San Diego,Calif.
When: April 13, 2008, 1:00 pm PT
PDL192 is an investigational monoclonal antibody that binds to the TWEAK (tumor necrosis factor-like weak inducer of apoptosis) receptor (TweakR), also known as Fn14 or TNFRSF12A, a cell surface protein with homology to the family of tumor necrosis factor (TNF) receptors. Dr. Culp’s team at PDL demonstrated that TweakR is over-expressed in a number of solid tumor indications including pancreatic, colon, lung, renal, breast and head & neck cancers. In pre-clinical studies PDL192 significantly inhibited tumor growth of various models of human cancer in mice.
The poster presentation will provide a detailed description of the pre-clinical data demonstrating the anti-tumor potential of PDL192, and the overall scientific rationale for brining this novel program into clinical testing in oncology. PDL BioPharma is planning to submit an IND for PDL192 in the second quarter of 2008 and intends to initiate a phase 1 clinical trial this year.
Forward-looking Statements
This press release contains forward-looking statements, including regarding PDL’s plan to submit an IND for PDL192 in the second quarter of 2008 and intent to initiate a phase 1 clinical trial of PDL192 in 2008. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, expressed or implied, in these forward-looking statements because of various factors, risks and uncertainties. In particular, results observed in pre-clinical studies of PDL192 may not be predictive of the results that would be observed in human clinical trials of PDL192 and the additional evaluations and studies that would be necessary to demonstrate PDL192 to be safe and effective in the treatment of patients and there can be no assurance that PDL will initiate clinical trials of PDL192, including the phase 1 trial, which PDL is currently planning. Other factors that may cause PDL’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are discussed in PDL’s filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" sections of its annual and quarterly reports filed with the SEC. Copies of PDL’s filings with the SEC may be obtained at the "Investors" section of PDL’s website at http://www.pdl.com. PDL expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in PDL’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
About PDL
PDL BioPharma, Inc. is a biopharmaceutical company focused on the discovery and development of novel antibodies in oncology and immunologic diseases. For more information, please visit http://www.pdl.com.
SOURCE: PDL BioPharma, Inc.
Post Views: 103
PDL BioPharma, Inc. announced today two presentations of data at medical conferences related to the company’s development-stage antibody products in multiple sclerosis and oncology
REDWOOD CITY, CA, USA | April 14, 2008 | PDL BioPharma, Inc. (NASDAQ: PDLI) announced today two presentations of data at medical conferences related to the company’s development-stage antibody products in multiple sclerosis and oncology. Details regarding each of the presentations are summarized below. Copies of the poster and plenary presentations will be available on PDL BioPharma’s website at the time of publication.
Daclizumab — Long-Term CHOICE Trial Follow-Up Data at AAN
Researchers will present 44-week follow-up data on the daclizumab phase 2 CHOICE trial in multiple sclerosis during a plenary session at the American Academy of Neurology (AAN) 60th Annual Meeting in Chicago on April 16.
Study: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Subcutaneous Daclizumab, a Humanized Anti-CD-25 Monoclonal Antibody, in Patients with Active, Relapsing Forms of Multiple Sclerosis – Week 44 Results Presenter: Michael Kaufman, M.D. Director of the Multiple Sclerosis Center at Carolinas Medical Center, representing the investigators
Where: The AAN annual meeting, McCormick Place West, Chicago
When: Plenary Session scheduled for 9:00 am CT April 16
Daclizumab is a humanized monoclonal antibody that binds to the IL-2 receptor on activated T cells, inhibiting the binding of IL-2 and the cascade of pro-inflammatory events contributing to organ transplant rejection and autoimmune-related diseases.
In October 2007, researchers presented positive 24-week follow-up data from the phase 2, randomized, double blind, placebo-controlled clinical study, known as the CHOICE trial. In patients with active MS, daclizumab used in combination with interferon beta therapy resulted in a substantial reduction in new/enlarged gadolinium contrast enhanced lesions compared to interferon beta therapy used in combination with a placebo. In general, the combination therapy was shown to be safe and well tolerated in the study.
Biogen Idec, PDL’s co-development partner, is currently enrolling patients in an additional study, the SELECT Trial, which evaluates daclizumab as a monotherapy for MS.
PDL192 — Poster Presentation at AACR
PDL presented pre-clinical data on its novel investigational drug, PDL192, on April 13 at the American Association for Cancer Research (AACR) Annual Meeting 2008, which takes place in San Diego, April 12-16.
Study: Anti-TweakR Antibodies Inhibit Tumor Growth In Vivo Through Dual Mechanisms Presenter: Patricia Culp, Ph.D, PDL BioPharma
Where: AACR Annual Meeting, San Diego Convention Center, San Diego,Calif.
When: April 13, 2008, 1:00 pm PT
PDL192 is an investigational monoclonal antibody that binds to the TWEAK (tumor necrosis factor-like weak inducer of apoptosis) receptor (TweakR), also known as Fn14 or TNFRSF12A, a cell surface protein with homology to the family of tumor necrosis factor (TNF) receptors. Dr. Culp’s team at PDL demonstrated that TweakR is over-expressed in a number of solid tumor indications including pancreatic, colon, lung, renal, breast and head & neck cancers. In pre-clinical studies PDL192 significantly inhibited tumor growth of various models of human cancer in mice.
The poster presentation will provide a detailed description of the pre-clinical data demonstrating the anti-tumor potential of PDL192, and the overall scientific rationale for brining this novel program into clinical testing in oncology. PDL BioPharma is planning to submit an IND for PDL192 in the second quarter of 2008 and intends to initiate a phase 1 clinical trial this year.
Forward-looking Statements
This press release contains forward-looking statements, including regarding PDL’s plan to submit an IND for PDL192 in the second quarter of 2008 and intent to initiate a phase 1 clinical trial of PDL192 in 2008. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, expressed or implied, in these forward-looking statements because of various factors, risks and uncertainties. In particular, results observed in pre-clinical studies of PDL192 may not be predictive of the results that would be observed in human clinical trials of PDL192 and the additional evaluations and studies that would be necessary to demonstrate PDL192 to be safe and effective in the treatment of patients and there can be no assurance that PDL will initiate clinical trials of PDL192, including the phase 1 trial, which PDL is currently planning. Other factors that may cause PDL’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are discussed in PDL’s filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" sections of its annual and quarterly reports filed with the SEC. Copies of PDL’s filings with the SEC may be obtained at the "Investors" section of PDL’s website at http://www.pdl.com. PDL expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in PDL’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
About PDL
PDL BioPharma, Inc. is a biopharmaceutical company focused on the discovery and development of novel antibodies in oncology and immunologic diseases. For more information, please visit http://www.pdl.com.
SOURCE: PDL BioPharma, Inc.
Post Views: 103
