NPI-0052 yet another update

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. 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.

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 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 and Revlimid. A clinical trial evaluating NPI-0052 in patients with solid tumors and lymphomas (NPI-0052-100) has been ongoing since 2006.

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

SOURCE: Nereus Pharmaceuticals, Inc.