Orphan Drug Status Granted to Vesimune for Bladder Cancer
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.
Most read news
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.