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 West Virginia University Research Corporation of Morgantown, West Virginia to evaluate SNS01-T, the Company’s lead therapeutic candidate, at the Mary Babb Randolph Cancer Center in the on-going Phase 1b/2a trial for the treatment of multiple myeloma.
The Mary Babb Randolph Cancer Center (MBRCC) is West Virginia’s premier cancer facility with a national reputation of excellence in cancer treatment, prevention and research. Located in Morgantown, within the Robert C. Byrd Health Sciences Center at West Virginia University School of Medicine, MBRCC is recognized by the American College of Surgeons Commission on Cancer for providing the best in cancer care. A multidisciplinary team of physicians, researchers and other healthcare experts work together to develop and implement the best possible individualized treatment plans, which include standard treatments and exciting alternatives offered through clinical trials. The principal investigator in the study at West Virginia University is Dr. Mehdi Hamadani.
“With the addition of MBRCC, we now have a total of three excellent clinical sites involved in recruiting patients into the multiple myeloma study with SNS01-T,” stated Leslie J. Browne, Ph.D, President and Chief Executive Officer of Senesco. “We expect that the additional broadening of patient access to SNS01-T achieved in the last week should significantly speed up completion of the study.”
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.