Telormedix, a clinical stage biopharmaceutical company focused on TLR7 agonists in the treatment of cancer and inflammatory diseases, today 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 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.
Neal Shore, MD, Medical Director, Carolina Urologic Research Center, Myrtle Beach, South Carolina and one of the Principal Investigators on this trial commented: "Bladder cancer is a disease with significant unmet therapeutic needs, with a paucity of new drug therapies for over 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. Vesimune intravesical therapy is a promising option with an alternative and promising pathway of therapeutic activity."
Johanna Holldack, CEO of Telormedix, added: "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 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.
Telormedix will be conducting an investigator meeting on 17 May while also attending the American Urological Association (AUA) conference on 16-21 May in Orlando, Florida.