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The Multiple Myeloma Research Consortium (MMRC) Announces the Initiation of Phase I/II Study of Elotuzumab (Huluc63) Monoclonal Antibody in Combination with Velcade


NORWALK, Conn. — July 18, 2008
Clinical Trial Evaluates Safety and Efficacy of Elotuzumab in combination with Velcade

(BUSINESS WIRE)--The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a Phase I/II study of elotuzumab (also known as Huluc63), a humanized anti-CS1 monoclonal IgG1 antibody administered intravenously, in combination with VELCADE® (bortezomib) for Injection for the treatment of relapsed multiple myeloma.

This study, sponsored by PDL BioPharma, Inc., and conducted at the following MMRC Member Institutions: the University of Michigan, Dana-Farber Cancer Institute, University of Chicago, Hackensack University Medical Center, and Roswell Park Cancer Institute, will evaluate the safety and efficacy of the combination in patients who have received one to three prior therapies. "Elotuzumab is a novel antibody that hits a target — CS1 — known to be highly expressed on myeloma cells with a restricted expression on normal cells," says Principal Investigator, Andrzej Jakubowiak, MD, PhD, Associate Professor, Hematology/Oncology at the University of Michigan. "Preclinical research suggests synergy between the antibody and Velcade, so we look forward to testing this promising new combination within the MMRC."

"The MMRC is proud to partner with PDL BioPharma to move this exciting new combination into the clinic. The MMRC's facilitation of this trial underscores our commitment to advancing clinical trials of novel compounds and combination approaches that show the most potential in effectively treating patients," said Kathy Giusti, Founder and Chief Executive Officer of the MMRC, as well as a myeloma patient.

About Elotuzumab

Elotuzumab (or HuLuc63) is a humanized monoclonal antibody under development by PDL BioPharma that binds to human CS1, a cell-surface glycoprotein that is highly and universally expressed on multiple myeloma cells but minimally expressed on normal cells. The antibody is currently being evaluated in Phase I clinical studies as a monotherapy and combination therapy for the treatment of relapsed multiple myeloma.

About VELCADE

VELCADE is being co-developed by Millennium Pharmaceuticals, The Takeda Oncology Company, and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S. and Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. are co-promoting VELCADE in the U.S. For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

About the Multiple Myeloma Research Consortium (MMRC)

The Multiple Myeloma Research Consortium (MMRC), a 509a3 organization, was founded in 2004 by Kathy Giusti, a myeloma patient and Founder and Chief Executive Officer of the Multiple Myeloma Research Foundation, to accelerate the development of novel and combination treatments for patients with multiple myeloma by facilitating innovative clinical trials and correlative studies.

At the core of the MMRC model is an exceptional Executive Committee, based in Norwalk, Conn., which provides strategic oversight of the MMRC's drug development projects. The MMRC's 15 Member Institutions are among the prominent academic research centers worldwide: City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, the Cancer Center at Hackensack University Medical Center, H. Lee Moffitt Cancer Center & Research Institute, Indiana University, Mayo Clinic, Ohio State University, Roswell Park Cancer Institute, St. Vincent's Comprehensive Cancer Center of Saint Vincent Catholic Medical Centers of New York, University Health Network (Princess Margaret Hospital), University of Chicago, University of Michigan, University of California – San Francisco, and Washington University.

The MMRC model also includes an advanced Tissue and Data Bank, which serve as a "bridge" between laboratory and clinical research conducted by the MMRC and a vital resource in advancing MMRC clinical trials and correlative science studies.

As a results-driven organization, the MMRC has facilitated to date 14 Phase I and II clinical trials of the most promising novel compounds and combination approaches. MMRC clinical trials are designed to include correlative studies to better understand what drugs are most effective in treating various sub-groups of myeloma patients, laying the foundation for the eventual development of personalized medicines as a treatment for myeloma.

For more information, visit www.themmrc.org.