Senesco's Lead Therapeutic Candidate, SNS01-T, Granted Orphan Drug Status from FDA for Treatment of Mantle Cell Lymphoma and Diffuse Large B-Cell Lymphoma
Senesco Technologies (NYSE: SNT) reported today that it was informed on July 26th that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for the company's lead drug candidate SNS01-T for treatment of both mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL). As a result, the company is eligible to receive a number of benefits, including tax credits, access to grant funding for clinical trials, accelerated FDA approval, allowance for marketing exclusivity after drug approval for a period of as long as seven years and potential exemption from the FDA's prescription drug application fee.
“We are pleased mantle cell and diffuse large B-cell lymphomas join multiple myeloma on the list of cancers for which SNS01-T has been granted orphan-drug status by the FDA,” said Leslie J. Browne, Ph.D., Senesco's Chief Executive Officer. “SNS01-T was designed to selectively trigger cell death in B-cell malignancies. Obtaining orphan-drug status for these cancers is complemented by the efficacy of SNS01-T in mouse models of MCL and DLBCL as well as our plans to evaluate the effectiveness of SNS01-T in patients with these cancers.”
The effects of SNS01-T in mouse models of MCL and DLBCL was presented orally on Thursday, May 17th, 2012 during the “Cancer-Targeted Gene & Cell Therapy” session at the 15th Annual Meeting of American Society of Gene & Cell Therapy in Philadelphia, PA.
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