Switzerland-based biopharmaceutical firm Telormedix has completed an open-label Phase II clinical trial, conducted under an IND, of Vesimune (TMX-101) in CIS (carcinoma in situ) of the bladder.
The trial involved 12 CIS patients recruited from sites in the US to examine the efficacy of Vesimune over six doses.
Population in the trial involved both BCG pre-treated and naïve patients with each patient receiving six weekly instillations of Vesimune into the bladder.
Out of the 12 patients, ten were evaluable with four showing a response and three of these were complete responders, so reached the clinical endpoint of complete remission after only one cycle of therapy.
In the trial, only mild and moderate side effects were observed mostly related directly to the bladder and comparable to other commonly used intravesical agents.
Carolina Urologic Research Center medical director and one of the principal investigators on the trial Neal Shore said bladder cancer is a disease with significant unmet therapeutic needs, with a lack of new drug therapies for more than three decades.
“Currently, BCG and valrubicin are the only FDA-approved intravesical options for bladder cancer, and if these options fail, then surgical removal of the bladder is considered,” Shore said.
“Vesimune intravesical therapy is a promising option with an alternative and promising pathway of therapeutic activity.”
The company said that 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 CEO Johanna Holldack said: “With this successful Phase II completed, we are now eager to speak to potential license partners we can work with to progress Vesimune to market.”
The company expects that in comparison to standard of care the targeted therapy will have an improved safety and efficacy profile.