The study is expected to be conducted in the Netherlands at four investigational sites and the company anticipates to evaluate total of 21 to 30 patients in the trial.
Telormedix said that Phase I/II study will be divided into three parts as an open-label, multicenter, dose escalation study.
The safety and maximum tolerated dose (MTD) will be tested in patients with NMIBC in the first part of the study, who have undergone a complete transurethral resection (TUR). TMX-101 will be administered once a week for a total of six instillations into the bladder of patients who have undergone TUR.
In the second part, the researchers are expected to assess the effective biological dose in patients with one marker lesion remaining after TUR.
Further, the third part of the study will follow each of the patients to assess the safety of TMX-101 and the status of the disease within the first year.
Johanna Holldack, CEO of Telormedix, said: “This trial marks a very significant milestone for Telormedix. In less than three years we have managed to advance our programmes to take our first product lead into the clinic which is a substantial achievement in our sector.”
Witjes, a urologist at the Radboud University Nijmegen Medical Center and principal investigator of the study, said: “Initial laboratory and animal studies have shown significant efficacy of TMX-101 so the clinical expectations are high.
“If the clinical trials are successful, TMX-101 could be the very first targeted therapy dedicated to this disease.”