Today, Senesco Technologies reported that the clinical trial of SNS01-T has been expanded to include diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). The company has enrolled the first patient with DLBCL in cohort 2; that patient received the first dose last week.
Like multiple myeloma, DLBCL and MCL are B-cell cancers that SNS01-T was designed to treat. Senesco submitted a protocol amendment to the United States Food and Drug Administration in August to open the study to patients suffering with these non-Hodgkin’s B-cell lymphomas. Having the ability to include other hematological cancers broadens Senesco’s results and can potentially accelerate patient enrollment at the three clinical sites where SNS01-T is being investigated. This should keep the company on track to disclose results of cohort 2 near the end of 2012.
Previously, Senesco reported that two of three patients that had completed dosing with SNS01-T in cohort 1 had not progressed on treatment, based on criteria that included the monoclonal protein; these patients were considered stable at week 3 and week 6, which was the end of the dosing regimen.
An open-label, multiple-dose, dose-escalation study, this trial is evaluating the safety and tolerability of SNS01-T when administered by intravenous infusion to around 15 relapsed or refractory multiple myeloma, DLBCL, and MCL patients. These patients are dosed twice a week for six weeks followed by an observation period. Members of the first group of multiple myeloma patients were given 0.0125 mg/kg – approximately 1 mg per patient – by intravenous infusion. The second group is currently receiving 0.05 mg/kg, and the planned dose levels for the third and fourth groups are, respectively, 0.2 and 0.375 mg/kg. The main objective of this study is to evaluate safety and tolerability, but the effect of SNS01-T on tumor response and time to relapse or progression will also be assessed using multiple well-established metrics.
Senesco Technologies is a leader in eIF5A technology. The company is currently running a clinical study in multiple myeloma with lead therapeutic candidate SNS01-T and has already partnered with leading companies that are engaged in agricultural biotechnology and biofuels development. Senesco is entitled to earn research and development milestones and royalties if its gene-regulating platform technology is incorporated into its partners’ products.
For more information, visit www.senesco.com
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