First Portion of TMX-101 Study Complete

Telormedix, a clinical stage biopharmaceutical company focused on TLR7 agonists in the treatment of cancer and inflammatory diseases, has successfully completed the safety portion of a Phase 1/2 trial for TMX-101.

This three-part trial is an open-label, multicenter, dose escalation study. In the first part of the study, which has now completed, safety was tested in patients with non-muscle-invasive bladder cancer (NMIBC) who had also 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. 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.

Johanna Holldack, CEO of Telormedix, commented, “Since 1984, no new drugs have been approved for the treatment of non-muscle invasive bladder cancer (NMIBC) .There is a high unmet clinical need for better and innovative therapies and Telormedix hopes to introduce its TMX-101, a TLR7 agonist, as a treatment for bladder cancer. Our study results so far are encouraging and we are excited that we are now able to initiate the marker lesion part of the study in order to evaluate the biological activity.”

The second part of the study will be an assessment of the effective biological dose in patients with one marker lesion remaining after TUR. Specifically, this study will examine TMX-101’s safety on Marker Lesions (MTD) focused on a dose level of 100 mg in 50 mL (0.2%) and  is scheduled to start in Q1/Q2 2012. The third and final part of the study will follow patients for one year for safety and status of the disease.

Date: March 19, 2012