US-based clinical-stage biotech firm Senesco Technologies has dosed the first patient in cohort 4 with its therapeutic candidate SNS01-T in a Phase Ib/IIa trial for the treatment of multiple myeloma and non-Hodgkins B-cell lymphoma (NHLs).
The open-label, multiple-dose, dose-escalation trial is aimed at assessing the safety and tolerability of SNS01-T when administered by intravenous infusion to about 15 relapsed or refractory multiple myeloma and B-cell lymphoma patients.
The primary objective of the trial is to assess safety and tolerability, the effect of SNS01-T on tumour response and time to relapse or progression is assessed using multiple well-established metrics including measurement of monoclonal protein in multiple myeloma and CT imaging in B-cell lymphomas.
Senesco president and CEO Leslie Browne said: "The dose level in cohort 4 of 0.375 mg/kg of SNS01-T is the dose that was most efficacious in the non-clinical cancer models that we used. As we have increased the dose level through the first three patient groups we have observed a steady increase in SNS01-T's effect. We expect this trend to continue."
Currently, the company is recruiting patients at five sites for the clinical trial and expects to increase the number in order to maintain enrolment into the trial and meet the goal of completing cohort 4 in the first half of 2014.
In the trial, patients are dosed twice-weekly by intravenous infusion for six weeks followed by an observation period.
The first three cohorts of patients were given 0.0125, 0.05 and 0.2mg/kg per dose, respectively, while the dose level for cohort 4 is 0.375mg/kg, which is 30 fold higher compared to the starting dose in group one.
The company intends to enrol six to nine patients in the trial in order to complete cohort 4.
SNS01-T, a novel, gene regulatory approach to cancer therapy, is designed to selectively trigger apoptosis in B-cell cancers such as multiple myeloma, and, mantle cell and diffuse large B-cell lymphomas.
Image: Micrograph of a plasmacytoma. Photo: courtesy of Nephron.