Date: 2012-03-20
Type of information: Initiation of preclinical development
phase: 1-2
Announcement: completion of the safety portion of the trial
Company: Telormedix (Switzerland)
Product: TMX-101
Action
mechanism: TLR7 agonist
Disease: non-muscle invasive bladder cancer (NMIBC)
Therapeutic area: Cancer Oncology
Country:
Trial
details: This is an open-label, multicenter, dose escalation study which will consist of three parts. In the first part of the study, the safety has been tested in patients with non-muscle-invasive bladder cancer (NMIBC) who have undergone a complete transurethral resection (TUR). TMX-101 was administered once a week for a total of six instillations into the bladder of patients after 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. The third part will follow patients for one year for safety and status of the disease.
Latest
news: Telormedix, a clinical stage biopharmaceutical company focused on TLR7 agonists in the treatment of cancer and inflammatory diseases, announced that it has completed the safety portion of a Phase I/II trial for TMX-101 successfully.
In the initial safety part no serious adverse events were reported and all related adverse events were mild to moderate in severity, with immediate resolution, and were mainly limited to the genitourinary system. Based on the results, the Dose Escalation Committee has concluded that intravesical instillation of TMX-101 is safe at doses from 0.05% up to and including 0.4% and recommended the continuation of the trial.
The second part of the study, which will examine TMX-101’s safety on Marker Lesions (MTD), is scheduled to start in Q1/Q2 2012 and will be focused on a dose level of 100 mg in 50 mL (0.2%).
