Telormedix’ TMX-101 Commences Clinical Trial for Bladder Cancer
Telormedix announced the start of a Phase I/II clinical study of TMX-101 for the treatment of Non-Muscle Invasive bladder cancer (NMIBC). TMX-101 is an immunotherapeutic compound and Telormedix has already recruited the first patients for this clinical study.
The trial will be a Phase I/II, open-label, multicenter, dose escalation study which will consist of three parts. In the first part of the study, the safety and maximum tolerated dose (MTD) will be tested in patients with non-muscle-invasive bladder cancer (NMIBC) 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. The second part of the study will be an assessment of the effective biological dose in patients with one marker lesion remaining after TUR. Finally, 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. The study will be conducted in the Netherlands at four investigational sites and Telormedix anticipates that there will be a total of 21 to 30 patients.
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