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Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor

Wednesday, August 15, 2007 General News
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NORWALK, Conn., Aug. 14 The Multiple MyelomaResearch Consortium (MMRC) today announced its participation in a Phase IIstudy to determine the efficacy of LBH589 for the treatment of patients withrelapsed or refractory multiple myeloma. LBH589 is an orally administereddeacetylase inhibitor developed by Novartis Pharmaceuticals.
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The MMRC is the only research model of its kind bringing together 13leading academic institutions to accelerate the development of novel andcombination treatments for multiple myeloma, an incurable cancer of the plasmacell. In addition to its most recent partnership with Novartis, the MMRC isfacilitating several other clinical trials, including a Phase I study of NPI-0052, a proteasome inhibitor, in collaboration with Nereus Pharmaceuticals,and a Phase I study of perifosine, lenalidomide (REVLIMID(R)), anddexamethasone in collaboration with Keryx Biopharmaceuticals.
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"Deacetylase inhibitors may represent a new treatment options for cancerpatients and the MMRC is proud to work with Novartis to advance this importantclinical program," said Kathy Giusti, Founder and Chief Executive Officer ofthe MMRC, as well as a myeloma patient. "This trial and the others the MMRC isfacilitating demonstrate the importance of novel collaborations in bringingnew treatments to patients."

Named ALPHA-MM, this trial is a single arm, open label, multi-centerglobal study that will enroll 144 patients in the United States, Canada, andEurope. MMRC Member Institutions that will enroll patients are Dana-FarberCancer Institute, City of Hope National Medical Center, Emory University,Hackensack University Medical Center, Mayo Clinic, H. Lee Moffitt CancerCenter & Research Institute, and Washington University.

This trial is open to patients with relapsed or refractory multiplemyeloma who have received at least two lines of therapy, and whose diseaseprogressed on their most recent therapy. Prior therapy must have includedbortezomib (VELCADE(R)) or lenalidomide.

LBH589 is part of a promising class of drugs called deacetylase inhibitorsor HDAC inhibitors, which may play an important role in helping to slow orstop the growth of multiple myeloma cells. Preclinical laboratory datasuggests that LBH589 has significant activity against multiple myeloma cells,including those that are resistant to conventional therapies.

About the Multiple Myeloma Research Consortium (MMRC)

The Multiple Myeloma Research Consortium (MMRC) is a 509(a)3 non-profitorganization that integrates leading academic institutions to accelerate drugdevelopment in multiple myeloma. It is led from MMRC offices in Norwalk,Conn., and comprises 13 member institutions: City of Hope, Dana-Farber CancerInstitute, Emory University's Winship Cancer Institute, the Cancer Center atHackensack University Medical Center, H. Lee Moffitt Cancer Center & ResearchInstitute, Mayo Clinic, Ohio State University, Roswell Park Cancer Institute,St. Vincent's Comprehensive Cancer Center of Saint Vincent Catholic MedicalCenters 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 withthe help of the scientific community. The MMRC is a sister organization to theMultiple Myeloma Research Foundation (MMRF), the world's leading funder ofmultiple myeloma research. The MMRC is widely recognized as an optimalresearch model to rapidly address critical challenges in drug development andto explore opportunities in the today's most promising research areas --genomics, compound validation, and clinical trials. The MMRC is the onlyconsortium 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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