Senesco Technologies, Inc. (“Senesco” or the “Company”) (NYSE MKT: SNT) reported today that the first patient has been enrolled and dosing has been initiated in cohort 2 of its clinical trial with SNS01-T in multiple myeloma. SNS01-T was well tolerated and met the criteria for Stable Disease in 2 of the 3 evaluable patients that comprised cohort 1.
"We were very pleased that the first group, infused with the lowest dose of SNS01-T provided encouraging results including two patients with stable disease of which one patient remained stable at 4 weeks and progressed at 8 weeks after the end of the dosing period," stated Leslie J. Browne, Ph.D., President and CEO of Senesco. "Now that cohort 2 is underway and there are three clinical sites recruiting patients we hope to be able to disclose results on the four-fold higher dose of approximately 4 mg per patient around the end of 2012."
The study is an open-label, multiple-dose, dose-escalation study, which is evaluating the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma patients. Patients are dosed twice-weekly for 6 weeks followed by an observation period. The first group of patients received 0.0125 mg/kg, approximately 1 mg per patient, by intravenous infusion. The planned dose levels for the second, third and fourth groups are 0.05, 0.2 and 0.375 mg/kg, respectively.
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 monoclonal protein.
SNS01-T is a novel approach to cancer therapy that is designed to selectively trigger apoptosis in B-cell cancers such as multiple myeloma, and, mantle cell and diffuse large B-cell lymphomas. Senesco is the sponsor of the Phase 1b/2a study that is actively enrolling patients at Mayo Clinic in Rochester, MN, the University of Arkansas for Medical Sciences in Little Rock, and the Mary Babb Randolph Cancer Center in Morgantown, WV.
About Multiple Myeloma
Multiple myeloma is an incurable cancer of plasma cells, a type of white blood cell derived from B-lymphocytes, normally responsible for the production of antibodies, in which abnormal cells accumulate in the bone marrow leading to bone lesions and interfering with the production of normal blood cells. Senesco was previously granted orphan drug status for SNS01-T, the Company’s lead drug candidate for treatment of multiple myeloma.