The Multiple Myeloma Research Consortium Commences Phase I/II Combination Study for the Treatment of Multiple Myeloma

Phase I/II Study to Explore the Safety and Efficacy of TORISEL in Combination With VELCADE in Patients With Relapsed or Refractory Multiple Myeloma


NORWALK, Conn., Sept. 17, 2007 (PRIME NEWSWIRE) -- The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a multi-center Phase I/II clinical program to explore the combination of TORISEL(tm) (temsirolimus), a novel mTOR inhibitor, and VELCADE(r) (bortezomib) for Injection, a proteasome inhibitor, for the treatment of relapsed or refractory multiple myeloma. Under the lead of Irene M. Ghobrial, M.D., of the Dana-Farber Cancer Institute, the study will also be conducted at two other MMRC Member Institutions, University of Michigan and Washington University.

The MMRC is the only research model of its kind that brings together 13 leading academic institutions to accelerate the development of novel and combination treatments for multiple myeloma, an incurable cancer of the plasma cell. In addition to this trial, the MMRC is supporting several other clinical trials, including a Phase I study of NPI-0052, a proteasome inhibitor, in collaboration with Nereus Pharmaceuticals; a Phase I study of TKI258, an FGFR3 (fibroblast growth factor receptor 3) inhibitor, in collaboration with Novartis Oncology; a Phase I study of perifosine, Revlimid(r), and dexamethasone in collaboration with Keryx Biopharmaceuticals; and a Phase I study of VELCADE and tipifarnib.

"The commencement of this trial is another example of how our collaborative research model works toward our goal of delivering new and better treatment options to patients," said Kathy Giusti, founder and chief executive officer of the MMRC. "The MMRC is committed to identifying and facilitating the testing of new combination therapies to effectively treat multiple myeloma."

This trial is open to patients with relapsed or refractory multiple myeloma who have received prior therapy. The Phase I component of this trial will evaluate the safety of VELCADE when given in combination with TORISEL and will identify the maximum tolerated dose (MTD) of the combination, as well as a recommended dose of the combination for Phase II study. The Phase II component of this trial will evaluate patients' response to the combination of VELCADE and TORISEL.

Data from pre-clinical studies have demonstrated that TORISEL in combination with VELCADE is highly active against multiple myeloma cells.

About TORISEL

For more information about TORISEL, visit www.wyeth.com.

About VELCADE

VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. For more information on VELCADE, visit www.velcade.com.

About the Multiple Myeloma Research Consortium (MMRC)

The Multiple Myeloma Research Consortium (MMRC) is a 509a3 non-profit organization that integrates leading academic institutions to accelerate drug development in multiple myeloma. It is comprised of the MMRC and 13 member institutions: City of Hope Cancer Center, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, Hackensack University Medical Center, H. Lee Moffitt Cancer Center & Research Institute, 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, and Washington University.

The MMRC was founded in 2004 by Kathy Giusti, a myeloma patient, and with the help of the scientific community. The MMRC is a sister organization to the Multiple Myeloma Research Foundation (MMRF), the world's leading funder of multiple myeloma research. The MMRC is widely recognized as an optimal research model to rapidly address critical challenges in drug development and to explore opportunities in the today's most promising research areas -- genomics, compound validation, and clinical trials. The MMRC is the only consortium to join academic institutions through membership agreements, customized IT systems, and an integrated tissue bank. For more information, please visit http://www.themmrc.org.


            

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