Senesco Technologies has completed first cohort of patients in its Phase Ib/IIa multiple myeloma trial of SNS01-T that is designed to selectively trigger apoptosis in B-cell cancers and diffuse large B-cell lymphomas.
SNS01-T was safe, well tolerated and met the criteria for stable disease in two of the three evaluable patients that comprised the first cohort. No drug-related serious adverse events or dose limiting toxicities were recorded for any patients.
The Data Review Committee advised Senesco that it was appropriate to proceed with the second cohort and escalate the dose level to 0.05mg/kg, a four-fold increase.
Senesco chairman Dr Harlan Waksal said the promising result observed in the first patient has been confirmed by a similar effect, stable disease, in another patient.
"We are looking forward to seeing the effect of increasing the dose level in the next group of patients," Waksal said.
In two of the three patients in the first cohort, disease had not progressed on treatment, based on several criteria including the monoclonal protein, and was considered stable at week three and week six, the end of the dosing regimen.
Three patients were withdrawn from the open-label, multiple-dose, dose-escalation study due to disease progression before completing treatment.
One of the responding patients has continued to have stable disease at week ten, a month after the end of treatment with SNS01-T.
Senesco president and chief executive officer Dr Leslie Browne said; "Now that we have seen an effect at the lowest dose in the study and can increase the dose level from ~1 to ~4 mg per patient, with three sites open we expect patient recruitment should be faster in cohort two."
The study will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma patients.