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The Multiple Myeloma Research Consortium (MMRC) Announces Initiation of Phase 1B Study of Elotuzumab (HuLuc63) Monoclonal Antibody in Combination With REVLIMID and Dexamethasone

October 13, 2008

The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a three-drug combination study of elotuzumab (also known as HuLuc63), a humanized anti-CS1 monoclonal IgG1 antibody administered intravenously, in combination with REVLIMID(R) (lenalidomide), and dexamethasone for the treatment of multiple myeloma in patients who are experiencing a relapse.

Emory University’s Winship Cancer Institute, Washington University, and St. Vincent’s Comprehensive Cancer Center of Saint Vincent Catholic Medical Centers of New York will evaluate the maximum tolerated dose of elotuzumab in combination with label dosing of lenalidomide and dexamethasone. The multi-center, open-label, dose-escalation Phase Ib study will enroll up to 26 patients.

“This three drug combination study is a pivotal study for patients with relapsed multiple myeloma as they may benefit from the synergistic effects of a new monoclonal antibody with two currently available drugs”, said Principal Investigator, Sagar Lonial, MD, Associate Professor of Medicine, at Emory University’s Winship Cancer Institute. “We look forward to testing this promising new combination.”

“The MMRC is proud to advance this combination trial as it aligns with our commitment to expand our portfolio of treatment options for multiple myeloma patients – especially those that show the most potential in effectively treating patients who have suffered a relapse.” said Kathy Giusti, Founder and Chief Executive Officer of the MMRC, and 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 REVLIMID(R)

REVLIMID, discovered and manufactured by Celgene Corporation, is approved for use in the EU, US Switzerland and Argentina for the treatment of multiple myeloma in combination with dexamethasone in patients who have received at least one prior therapy, and Australia for patients with multiple myeloma whose disease has progressed after one therapy. REVLIMID is an IMiDs compound, a member of a proprietary group of novel immunomodulatory agents. For more information, visit www.revlimid.com.

About the Multiple Myeloma Research Consortium (MMRC)

The Multiple Myeloma Research Foundation (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 15 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.




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