The Multiple Myeloma Research Consortium And Nereus Pharmaceuticals Initiate Clinical Trial Investigating NPI-0052 To Treat Multiple Myeloma

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 17 Apr 2007 - 0:00 PDT

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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 Velcade(R) (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, Thalomid(R) (thalidomide, Celgene Corporation) and Revlimid(R) (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 http://www.nereuspharm.com.

Nereus Pharmaceuticals is a registered trademark of Nereus Pharmaceuticals, Inc.

Nereus Pharmaceuticals, Inc.
http://www.nereuspharm.com

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