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Atiprimod Granted Orphan Drug Designation for Multiple Myeloma Indication
Atiprimod has unique properties, centering on its ability to inhibit angiogenesis and proliferation of cancer cells through its ability to inhibit production of vascular endothelial growth factor (VEGF) and Interleukin-6 (IL-6), two essential factors for tumor growth and metastasis in multiple myeloma and other solid tumors. Patients will also be evaluated for the effect of Atiprimod on bone resorption, a debilitating side effect of multiple myeloma. Other anti-cancer uses for Atiprimod are presently being evaluated pre-clinically in collaboration with the National Cancer Institute.
The FDA grants orphan drug status for drug candidates that are intended to treat rare life-threatening diseases that, at the time of application, affect no more than 200,000 patients in the United States. The drug must have the ability to provide significant patient benefit over currently available treatment or fill an unmet medical need. Orphan drug designation entitles Callisto to seven years of market exclusivity in the United States upon FDA approval, provided that Callisto continues to meet certain conditions established by the FDA.
Once the FDA grants marketing approval of a new drug, the FDA will not accept or approve other applications to market the same medicinal product for the same therapeutic indication. Other incentives provided by orphan status include certain tax benefits, eligibility for research grants and protocol assistance. Protocol assistance includes regulatory assistance and possible exemptions or reductions of certain regulatory fees.
Source: Callisto Pharmaceuticals, Inc.