Multiple Myeloma Research Consortium (MMRC), Emory University Commence Multi-Center Combination Study for the Treatment of Multiple Myeloma

Norwalk, Conn. — June 14, 2007
Study to Determine Safety of VELCADE® (bortezomib) for Injection in Combination Tipifarnib in Patients with Relapsed or Refractory Multiple Myeloma

The Multiple Myeloma Research Consortium (MMRC) and Emory University today announced the initiation of a multi-center Phase I clinical trial to determine the optimal dose level of VELCADE® (bortezomib) for Injection, a proteasome inhibitor, in combination with tipifarnib, a first-in-clinic farnesyl transferase inhibitor, for the treatment of patients with relapsed or refractory multiple myeloma.

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. The MMRC is currently 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; and a Phase I study of perifosine, Revlimid®, and dexamethasone in collaboration with Keryx Biopharmaceuticals.

Entitled "A Phase I Protocol of the Combination Bortezomib and Tipifarnib for Relapsed or Refractory Multiple Myeloma," the MMRC's most recent clinical program represents its first international effort. MMRC Member Institutions that will enroll patients are City of Hope National Medical Center in Duarte, Calif., Emory University in Atlanta, Ga., and University of Toronto in Toronto, Ontario. Emory University and Dana-Farber Cancer Institute in Boston, Mass., will conduct associated correlative science studies.

"Encouraging pre-clinical data suggest that VELCADE in combination with tipifarnib may prove to be more active against multiple myeloma cells than either agent alone,"said Sagar Lonial, M.D., Associate Professor of Medicine at Emory University's Winship Cancer Institute and the study's principal investigator. "With the MMRC's support, we are able to take the first step in the clinical exploration of this promising combination therapy."

Pre-clinical laboratory data suggests that VELCADE and tipifarnib in combination have synergistic activity against multiple myeloma cells.

"The MMRC is pleased to partner with Emory to advance this new combination therapy to the clinic," said Kathy Giusti, Founder and Chief Executive Officer of the MMRC, as well as a myeloma patient. "Through this trial and other clinical programs we support, the MMRC continues to build collaborations that are so urgently needed to bring new treatment options to patients."

About VELCADE® (bortezomib) for Injection

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 www.themmrc.org.

About Emory University's Winship Cancer Institute

As a leader in cancer patient care and research, Emory University's Winship Cancer Institute serves as the coordinating center for a vast array of resources in medical, surgical, and radiation oncology, diagnostic imaging, and the subspecialties of cancer care throughout Emory University—from blood and bone marrow stem cell transplants to internationally recognized aerodigestive tract cancer treatment, research, and care.

Specific research projects that are currently underway include:

  • NIH funded studies of a "policing gene" that may protect against breast, ovarian, and prostate cancer.
  • Clinical trials of melanoma vaccines and treatments for metastatic melanoma.
  • Investigations into new drugs and vaccines for AIDS-related cancers.

For more information on The Winship Cancer Institute, visit www.cancer.emory.edu or call 888-WINSHIP (888-946-7447).