Pre-clinical data demonstrate that NPI-0052, a second generation proteasome inhibitor developed by Nereus Pharmaceuticals, may have potential in treating myeloma patients. NPI-0052 has been shown in vitro to be active against myeloma cells that are resistant/refractory to Velcade®, steroid, Thalomid and Revlimid therapies, and appears to exhibit lower levels of toxicity than existing treatments in preclinical models. NPI-0052 has also demonstrated activity against animal models of myeloma when given orally or intravenously. As such, NPI-0052 may hold promise in treating myeloma patients, including those with advanced disease who have not responded to or progressed on other treatments.

A Phase I clinical trial of NPI-0052, conducted in collaboration with Nereus Pharmacueticals, is now being initiated. This trial was designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of NPI-0052. It will enroll approximately 35 patients with relapsed or relapsed/refractory multiple myeloma.

This trial is being performed entirely within the MMRC. The four MMRC Member Institutions that will accrue patients for this trial are:

• Dana-Farber Cancer Institute
• Ohio State University Comprehensive Cancer Center
• Roswell Park Cancer Institute
• University of Chicago

The MMRC is also supporting associated correlative studies, including serial evaluations of proteasome inhibition, to evaluate the biological activity of NPI-0052 in myeloma patients.

For more information about this clinical trial, contact Alicia Sable-Hunt, RN, MMRC Program Manager, at sablehunt@themmrc.org.