Senesco Technologies, Inc. (“Senesco” or the “Company”) (OTCQB:SNTI) reported results of cohort 3 in its Phase 1b/2a clinical study of SNS01-T at the 55th American Society of Hematology Annual Meeting in New Orleans.
Four heavily pre-treated, relapsed or refractory patients, two with diffuse large B-cell lymphoma (DLBCL) and two with multiple myeloma, who were enrolled in cohort 3 at a dosage of 0.2 mg/Kg, completed treatment. Three of the four patients were evaluable for safety. One patient had a dose reduction to 0.05 mg/kg due to pre-existing thrombocytopenia and was not evaluable for safety. No dose-limiting toxicities have been observed in any of the first three cohorts. As previously reported, based upon review of three patients treated at 0.2 mg/kg the Data Review Committee recommended dose escalation to the 4
dose level (0.375 mg/kg) and continued enrollment.
“In addition to the absence of dose-limiting toxicity, since all patients in cohort 3 completed the full protocol-specified 6-week treatment period, we appear to be seeing longer treatment durations and fewer dropouts compared to cohorts 1 and 2,” stated Alice S. Bexon, M.D., Vice President of Clinical Development. The most frequent adverse events are manageable infusion reactions, which decrease with repeated treatments and platelet count decreases, which recover over time. One myeloma patient had reductions in disease-related proteins in his blood and a second patient with DLBCL had evidence of tumor shrinkage in some lesions.”
Like the previous treatment group, all four patients included at this dose level were refractory to, or had relapsed on, a significant number of previous treatments. Upon treatment with SNS01-T, three of the four patients exhibited stable disease at week 3 and two of the four were stable at week 6, the end of treatment.
“The safety profile continues to be a positive feature of SNS01-T in this study,” stated Leslie J. Browne, Ph.D., President and Chief Executive Officer of Senesco. “Since our preclinical data in myeloma and lymphoma demonstrated significant tumor shrinkage at 0.375 mg/kg of SNS01-T, with a p-value of <0.01, we will be looking for evidence of clinical activity at this dose level in cohort 4.”