The Multiple Myeloma Research Consortium and Nereus Pharmaceuticals Initiate Clinical Trial Investigating NPI-0052 to Treat Multiple Myeloma

05-01-2007

The Multiple Myeloma Research Consortium (MMRC) and Nereus Pharmaceuticals, Inc., a pioneer in drug discovery and development from marine microbial sources, 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.

Keywords: Cancer, Clinical Trial Research, Clinical Trials, Drug Development, Drug Discovery, Multiple Myeloma, Myeloma, Nereus Pharmaceuticals Inc., Oncology, Pharmaceutical Business, Pharmaceutical Company, Pre-Trials Research, Therapy, Treatment, Nereus Pharmaceuticals Inc.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.