Senesco Technologies, Inc. (“Senesco” or the “Company”) (NYSE AMEX: SNT) today announced that it has received Institutional Review Board approval and has finalized a clinical trial research agreement with the University of Arkansas for Medical Sciences (“UAMS”) in Little Rock, Arkansas to evaluate SNS01-T, the Company’s lead therapeutic candidate for the treatment of multiple myeloma in the on-going Phase 1b/2a study.
The University of Arkansas for Medical Sciences (“UAMS”) is one of the region's major academic health centers, located in Little Rock, Arkansas, with outreach programs operating in every county and a regional campus in Northwest Arkansas. The principal investigator in the study at UAMS is Saad Usmani, M.D., Director of Developmental Therapeutics in the Myeloma Institute for Research & Therapy.
“We are very pleased to have added UAMS as a clinical site along with the Mayo Clinic in order to accelerate patient enrollment and increase awareness of the SNS01-T study,” stated Leslie J. Browne, Ph.D, President and Chief Executive Officer of Senesco. “We believe that the addition of UAMS will help accomplish both of these objectives by broadening access to the trial.”
In the study, patients are dosed twice-weekly for 6 weeks followed by an observation period. The first group of three patients will receive 0.0125 mg/kg by intravenous infusion. At the end of their 6 weeks of dosing, safety data for the group will be reviewed before the subsequent group receives a higher dosage. The escalated doses administered to the second to fourth groups will be 0.05, 0.2 and 0.375 mg/kg, respectively. The study is an open-label, multiple-dose, dose-escalation study, which will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to a total of approximately 15 relapsed or refractory multiple myeloma patients. While the primary objective of this study is to evaluate safety and tolerability, the effect of SNS01-T on tumor response and time to relapse or progression will be assessed using multiple well-established metrics including measurement of the monoclonal protein (M-protein). Patient dosing in the study was initiated in November, 2011 at the Mayo Clinic in Rochester, Minnesota.