Senesco Technologies, Inc. ("Senesco" or the "Company") (NYSE Amex: SNT), announced today that the U.S. Food and Drug Administration (the "FDA") has informed the Company that its planned study in multiple myeloma is on hold until the Drug Master File (the "DMF") of one of its suppliers is updated. At the same time, Senesco was informed by the FDA that there are no other significant, outstanding issues that would delay the initiation of the clinical study associated with the Company's IND submission.
"We are disappointed that our supplier's DMF needs to be updated but believe that this can happen expeditiously," said Leslie J. Browne, Ph.D., Chief Executive Officer. "On the other hand we are pleased that Senesco's IND seems to have addressed all other major manufacturing, safety and clinical criteria. Senesco will work closely with FDA and our supplier to provide the requested information so that planned clinical studies in multiple myeloma can start as planned in the first half of 2011."
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