Senesco Technologies, Inc. (“Senesco” or the “Company”) (NYSE MKT: SNT) reported today that it was informed on July 26 th 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 17 th, 2012 during the “Cancer-Targeted Gene & Cell Therapy” session at the 15 th Annual Meeting of American Society of Gene & Cell Therapy in Philadelphia, PA.
The United States Orphan Drug Act of 1983 was created to promote the development of new drug therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States.About SNS01-T SNS01-T is a novel approach to cancer therapy that is designed to selectively trigger apoptosis in B-cell cancers such as multiple myeloma, and, mantle cell and diffuse large B-cell lymphomas. Senesco is the sponsor of the Phase 1b/2a study that is actively enrolling patients at Mayo Clinic in Rochester, MN, the University of Arkansas for Medical Sciences in Little Rock, and the Mary Babb Randolph Cancer Center in Morgantown, WV. http://www.clinicaltrials.gov/ct2/show/NCT01435720?term=SNS01-T&rank=1 About Multiple Myeloma Multiple myeloma is an incurable cancer of plasma cells, a type of white blood cell derived from B-lymphocytes, normally responsible for the production of antibodies, in which abnormal cells accumulate in the bone marrow leading to bone lesions and interfering with the production of normal blood cells. Senesco was previously granted orphan drug status for SNS01-T, the Company’s lead drug candidate for treatment of multiple myeloma.