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Breaking News, Trials & Filings

Senesco Begins Dosing in New Cohort

Continues dose escalation in multiple myeloma and non-Hodgkins B-cell lymphoma

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Senesco Technologies has administered SNS01-T to the first patient in cohort 4 of its Phase Ib/IIa study in multiple myeloma and non-Hodgkins B-cell lymphoma. The company has five sites recruiting patients for the trial and expects to increase this number in order to maintain enrollment and complete cohort 4 in 1H14.

The study is an open-label, multiple-dose, dose-escalation study to evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma and B-cell lymphoma patients. The primary objective is to evaluate safety and tolerability, but Senesco will also assess the effect of SNS01-T on tumor response and time to relapse or progression using multiple metrics, including measurement of monoclonal protein in multiple myeloma and CT imaging in B-cell lymphomas.

In the study, patients are dosed twice-weekly by intravenous infusion for six weeks followed by an observation period. The first three cohorts of patients received 0.0125, 0.05 and 0.2 mg/kg per dose, respectively. The dose level for cohort 4 is 0.375 mg/kg, which is 30 times higher than the starting dose in group 1. It is expected that the study will enroll six to nine patients to complete cohort 4.

SNS01-T is a gene-regulatory 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.

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