Orphan Drug Status Granted to Vesimune for Bladder Cancer
Telormedix announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Vesimune for the treatment of carcinoma in situ (CIS) in the bladder.
The FDA grants orphan drug status to products for rare diseases and defines a rare disease as one with a prevalence of less than 200,000 cases in the USA. As there are approximately 60.000 cases of non-muscle invasive CIS of the bladder, it is clearly a rare disease meaning that the orphan designation was extended to Vesimune.
Vesimune is Telormedix’ lead product, a TLR-7 agonist, that has successfully completed a Phase II trial in CIS of the bladder. The product is a unique sterile liquid formulation of a marketed immune modulatory compound, designed on innovative technology principles to carrier drug delivery systems in order to increase solubility, bio-adhesiveness and stability. These properties mean that the product can be used in therapeutic settings that the original product could not.
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