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Senesco Technologies, Inc. (“Senesco” or the “Company”) (OTC QB: SNTI) reported results of cohort 2 in its Phase 1b/2a clinical study of SNS01-T.
In cohort 2, the requisite number of 3 patients was evaluable for the primary safety endpoint from the total of 4 enrolled. Two multiple myeloma patients and one diffuse large B-cell lymphoma patient completed the required number of doses to be evaluable. As with the previous dose level, there were no drug-related serious adverse events or dose-limiting toxicities in either the evaluable patients or in the one patient who received only 5 infusions before being withdrawn. Over cohorts 1 and 2 at the two lowest dose levels, stabilization of serum monoclonal protein levels has been observed in three of the five evaluable multiple myeloma patients, and, in three of nine patients overall.
“Now that cohort 2 is completed, we are pleased to be recruiting patients into cohort 3 at a four-fold increase in the dose level from 0.05 mg/kg to 0.2 mg/kg, where we have seen efficacy in the preclinical cancer models in mice,” stated Leslie J. Browne, Ph.D., President and Chief Executive Officer of Senesco. “We are also pleased to have Dr. Alice Bexon join Senesco as Vice President of Clinical Development to lead our clinical activities and focus on timely patient enrollment.”
Like the previous group, all four patients included at this dose level were refractory to, or had relapsed on, a significant number of previous treatments, including bone marrow transplant in 3 of the 4 patients. One of the 3 myeloma patients at this dose level showed stabilization of their serum monoclonal protein levels at weeks 3 and 6, while 2 patients progressed during treatment. The single DLBCL patient treated at this dose level had progressive disease at week 6.
“I am very encouraged by the absence of drug-related safety issues at the lower doses with this exciting new targeted approach to treating B-cell cancers,” stated Alice S. Bexon, M.D., Vice President of Clinical Development. “We will be looking for more robust evidence of therapeutic effect at the higher dose levels. Our extensive preclinical data in animal models of myeloma and lymphoma showed strong evidence of target engagement, biomarker decreases and tumor shrinkage at 0.2 to 0.375 mg/kg of SNS01-T.”