Telormedix, a Switzerland-based clinical stage biopharmaceutical company focusing on toll-like receptor 7 (TLR7) small molecules in the treatment of cancer and inflammatory diseases, has recruited the first patient in a phase II trial of its lead product TMX-101, a TLR-7 agonist, in carcinoma in situ (CIS) in the bladder.

The planned phase II study with TMX-101 will involve a small number of CIS patients recruited from private urology clinics in the U.S. to examine the efficacy of the drug over six doses.

Patients with high-grade tumors or CIS currently most often receive treatment with Bacillus Calmette-Guérin (BCG), an intravesical immunotherapy that is unfortunately often accompanied by prolonged bladder irritation, fever and bleeding, which may force the doctor to decrease the BCG dosage or to discontinue the therapy.

“It is great to be starting 2013 with significant progress in advancing our product TMX-101 in the clinic, as we believe that it will offer several advantages over the current standard treatment with BCG,” said Dr. Johanna Holldack, CEO of Telormedix. “Our specialist oncology CRO, Medelis, is also doing superb work on this trial and has been supporting us through the whole IND set up process.”

Neal D. Shore, M.D., principal investigator in this trial, added, “TMX-101 has already demonstrated a strong disease-modifying cytokine response in a clinical trial involving patients with non-muscle invasive bladder cancer (NMIBC). CIS is obviously a more aggressive cancer, but we do know that it responds well to immunotherapeutic interventions. We are therefore extremely hopeful that targeting TLR-7 with TMX-101 will prove to be a successful and efficacious treatment option in these patients.”