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THE MULTIPLE MYELOMA RESEARCH CONSORTIUM AND NEREUS PHARMACEUTICALS INITIATE CLINICAL TRIAL INVESTIGATING NPI-0052 TO TREAT MULTIPLE MYELOMA
SAN DIEGO, Calif. & NORWALK, Conn., April 16, 2007 - The Multiple Myeloma
Research Consortium (MMRC) and Nereus Pharmaceuticals, Inc., a pioneer in drug
discovery and development from marine microbial sources, today announced the
enrollment of the first patient in a multi-center Phase I clinical trial to
study Nereus' novel, second generation proteasome inhibitor NPI-0052 in patients
with multiple myeloma.
The trial will evaluate the safety, tolerability, pharmacokinetic profile,
pharmacodynamics and efficacy of NPI-0052 in a single-agent, dose escalation
study of patients with relapsed or relapsed/refractory multiple myeloma. MMRC
member institutions prepared to enroll patients in the trial are The Dana-Farber
Cancer Institute (Paul Richardson, M.D.), Ohio State University (Craig
Hofmeister, M.D.), Roswell Park Cancer Institute (Asher Chanan-Khan, M.D.) and
University of Chicago (Todd Zimmerman, M.D.). Participants in the open label
study will receive escalating, once-weekly intravenous doses of NPI-0052 to
determine the safety profile in this patient population. Secondary objectives
will include response, pharmacokinetic and pharmacodynamic analyses.
- This study will allow us to evaluate a new proteasome inhibitor, which
preclinical studies suggest may have advantages compared to currently available
therapies, and thus could eventually become an important addition to our
therapeutic armamentarium, said Paul Richardson, M.D., Clinical Director of the
Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, who
enrolled the first patient. Dr. Richardson and his colleagues Kenneth Anderson,
M.D. (Director of the Jerome Lipper Multiple Myeloma Center) and Dharminder
Chauhan, Ph.D. have been involved in investigating NPI-0052 in laboratory models
of multiple myeloma and other cancers providing impetus for such clinical
studies.
- Based on these and other laboratory studies, we believe that NPI-0052 could
represent an important new option for multiple myeloma patients, said Kathy
Giusti, Founder and Chief Executive Officer of the MMRC, as well as a myeloma
patient. Through this innovative program and the others we support, our
organization continues to facilitate unprecedented collaborations between
industry and academia that are expediting meaningful new research and drug
development opportunities.
NPI-0052 was discovered from a new marine actinomycete (Salinispora tropica).
The compound is a potent inhibitor of human proteasomes, a high-interest drug
target for pharmaceutical companies after VelcadeŽ (bortezomib, Millennium) was
approved for the treatment of multiple myeloma and mantle cell lymphoma.
Preclinical studies indicate NPI-0052 is active against models of many common
cancers, including solid tumors, lymphomas and myeloma, including myeloma cells
from patients who are resistant to Velcade, steroid therapy, ThalomidŽ
(thalidomide, Celgene Corporation) and RevlimidŽ (lenalidomide, Celgene
Corporation). A clinical trial evaluating NPI-0052 in patients with solid tumors
and lymphomas (NPI-0052-100) has been ongoing since 2006.
- Given the preclinical data suggesting NPI-0052 may have utility in a number of
cancers including multiple myeloma, solid tumors, lymphomas and chronic
lymphocytic leukemia, we are excited to be expanding our clinical program. The
MMRC has made great strides in facilitating the development of effective new
treatments for myeloma, and we are very pleased that its sponsorship has made
the initiation of this trial possible. We have been impressed with the
scientific expertise this group brings to bear in the field of multiple myeloma,
said Matthew A. Spear, M.D., Chief Medical Officer of Nereus Pharmaceuticals,
Inc.
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, as an optimal research model to rapidly
address critical challenges in accelerating drug development and explore
opportunities in the most promising areas of myeloma research 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.
About Nereus Pharmaceuticals, Inc.
Nereus Pharmaceuticals pursues untapped sources of chemical diversity to
discover and develop novel therapeutics. With unmatched expertise in marine
microbiology and integrated technologies to identify novel biologically active
compounds, the Company's two oncology drug candidates are in Phase I clinical
trials. NPI-2358, a vascular disrupting agent, is being evaluated in patients
with solid tumors and lymphomas, and the proteasome inhibitor NPI-0052 is being
developed in patients with solid tumors, lymphomas and multiple myeloma. The
Company's discovery portfolio also includes potential drug candidates for
cancer, infectious diseases and inflammation. For more information, visit
www.nereuspharm.com.
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Nereus Pharmaceuticals is a registered trademark of Nereus Pharmaceuticals, Inc.
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