August 22, 2008
The Multiple Myeloma Research Consortium (MMRC) Partners With Celgene Corporation on Phase I/II Trial of Pomalidomide (CC-4047) in Relapsed and Refractory Multiple Myeloma Patients
The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a clinical trial with the oral immunomodulatory agent pomalidomide (CC-4047) in patients who have received at least two prior therapies including treatments with REVLIMID(R) (lenalidomide) and VELCADE(R) (bortezomib) for Injection.
Paul Richardson, MD, Clinical Director of the Jerome Lipper Center for Multiple Myeloma at Dana-Farber Cancer Institute, is leading the Phase 1 / 2, multicenter, randomized, open-label, dose-escalation study. The Phase 1 study is designed to determine maximum tolerated dose of single-agent pomalidomide while the Phase 2 randomized study will compare the oral compound's efficacy alone against its combination with dexamethasone.
"This potent new immunomodulator, which is in the same class as thalidomide and lenalidomide, will hopefully be successful in treating patients who have relapsed or who don't respond to currently available treatment options. We are excited to be testing pomalidomide in this context and are optimistic that it will meaningfully add to our therapeutic options for our patients," said Dr. Richardson.
"This new clinical trial brings the total number of studies that the MMRC has initiated to fourteen. We are thrilled to advance this study in our mission to identify and prioritize the most promising treatments for patients with multiple myeloma", said Kathy Giusti, Founder and Chief Executive Officer of the MMRC, and a myeloma patient.
Pomalidomide is an IMiDs compound, a member of Celgene's proprietary group of novel oral immunomodulatory agents that impede or stabilize disease through several mechanisms of action, including anti-angiogenic activity.
Celgene's lead IMiDs compound, REVLIMID(R) (lenalidomide) continues to demonstrate unprecedented overall survival in multiple myeloma as well as significant clinical potential across a broad range of blood cancers. To date, REVLIMID has obtained orphan drug designation for myelodysplastic syndrome in the European Union (EU), United States (US), and Australia, orphan drug designation for multiple myeloma (MM) in the EU, US, Australia and Switzerland, and orphan drug designation for chronic lymphocytic leukemia (CLL) in the EU and US. REVLIMID is currently approved for use in the US and Canada for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is also approved for use in the EU, US and Switzerland 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.
IMiDs compounds are proprietary novel small molecule, orally available compounds that modulate the immune system and other biologically important targets through multiple mechanisms of action, including angiogenesis inhibition, modulation of the levels of key pro-inflammatory and regulatory cytokines and immune cell co-stimulation (eg, T cells, NK cells)
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.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.