Telormedix’s Vesimune Successfully Completes Phase II for Carcinoma In Situ of the Bladder
Telormedix announced that it has successfully completed a Phase II trial, conducted under an IND, of Vesimune (TMX-101) in CIS (carcinoma in situ) of the bladder.
The open-label Phase II clinical trial involved 12 CIS patients recruited from sites in the USA to examine the efficacy of Vesimune over six doses. The study population involved both BCG (Bacillus Calmette-Guérin) pre-treated and naïve patients and each patient received 6 weekly instillations of Vesimune into the bladder. Ten of the 12 patients were evaluable with 4 showing a response. 3 out of the 4 were complete responders and therefore reached the clinical endpoint of complete remission after only one cycle of therapy. Only mild and moderate side effects were found mostly related directly to the bladder (burning, urge to void) and comparable to other commonly used intravesical agents.
The active ingredient in Vesimune is a known immuno-modulatory molecule with a favourable safety profile and a demonstrated clinical efficacy in oncological and viral diseases. Telormedix expects that this targeted therapy will have an improved safety and efficacy profile in comparison to standard of care.
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