Senesco Technologies, Inc. (“Senesco” or the “Company”) (NYSE MKT: SNT) reported today that it has completed the first cohort of patients in its Phase 1b/2a clinical trial for the treatment of multiple myeloma in which SNS01-T was safe and well tolerated and met the criteria for Stable Disease in 2 of the 3 evaluable patients that comprised cohort 1.
The safety data for the group were provided to the Data Review Committee (DRC) which advised Senesco that SNS01-T was safe and well tolerated and that it is appropriate to proceed with cohort 2 and to escalate the dose level to 0.05 mg/kg, a four-fold increase. No drug-related serious adverse events or dose limiting toxicities were recorded for any patients.
“We are extremely pleased with the results so far from the Phase 1b/2a study,” stated Harlan Waksal, M.D., Chairman of Senesco. “The promising result that we 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.”
The requisite number of 3 patients was evaluable from a total of 6 patients enrolled in the cohort. In two of these three patients their disease had not progressed on treatment, based on several criteria including the monoclonal protein, and was considered stable at week 3 and week 6, the end of the dosing regimen. Three patients were withdrawn from the study by their physicians due to disease progression before completing treatment. One of the responding patients has continued to have Stable Disease at week 10, a month after the end of treatment with SNS01-T.“SNS01-T’s profile in the clinic is very encouraging,” stated Leslie J. Browne, Ph.D., President and Chief Executive Officer of Senesco. “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 2. We hope to be able to disclose results from that cohort around the end of this year.”