FDA Grants Orphan Drug Status to Senescoâ€™ SNS01-T
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.
Multiple myeloma is a cancer of plasma cells, a type of white blood cell 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.
Up to two-thirds of patients with the disease currently survive less than five years. Senesco was previously granted $244,479 in immediately available funds from the US government under the Qualified Therapeutic Discovery Project in connection with the companyâ€™s multiple myeloma program.
Leslie Browne, CEO of the company, said: â€œWe are pleased that the FDA has granted orphan drug status for our lead therapeutic candidate SNS01-T as we prepare to begin our clinical studies in multiple myeloma.
â€œOrphan drug designation can provide us with significant regulatory and financial advantages to rapidly move our candidate forward in clinical trials. We believe that the tumor growth inhibition observed during preclinical studies is very promising and that orphan drug status could allow Senesco to accelerate clinical development and hopefully make this therapy available to patients sooner.â€
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