Pharmaceutical Business review

Trin Gets Approval From German Regulatory Authority

Trin Pharma (Trin) has reported that BfArM, the German Regulatory Authority, has approved the start of a Phase I clinical trial of TRIN 2755 in solid tumors. The trial is expected to be conducted at two clinical sites in Germany, Westdeutsches Tumorzentrum in Essen and Tumor Biology Center in Freiburg.

The company said that TRIN 2755 is based on a new chemistry with solid IP platform. Preclinical experiments have demonstrated positive activity of TRIN 2755 in xenograft models of human malignant melanoma, breast and colon cancer, including drug resistant tumors.

The study result suggested that the vast majority of animals treated with TRIN 2755 reached complete and stable remission at well tolerated doses. TRIN 2755, the company’s lead molecule in a series of new triazene analogs, which exerts rapid metabolic clearance and is tolerable in early toxicology studies.

Stefan Wohlfeil, CEO of Trin, said: “We are very excited about the start of the clinical development of our lead molecule. We believe that TRIN 2755 has a high likelihood of showing clinical benefit and to become an important part of anti-cancer therapy.”