Tiltan Pharma started its first human trial with its investigational product (IP), phase 1/2, on November 2006 in Sheba Medical Center, Israel. The main objective of the study was to evaluate the safety of Tiltan Pharma’s IP. The study recruited 31 advanced cancer patients with solid tumors. The safety analysis concluded that the investigational product was safe and tolerable with expected manageable adverse events.
The second major study was a phase 2 open-label one-arm study (TLH-202), in metastatic castration resistant prostate cancer (CRPC) patients. It was initiated on March 2009. The study was held in 7 medical centers in Israel and recruited 49 patients. Safety analysis was consistent with the initial findings of the first study. The final report is being prepared.
Currently, Tiltan Pharma is conducting a phase 2 study in metastatic pancreatic patients, TLH-206. The study is an open-label two-arm study. It is held in 8 medical centers in Israel and 2 medical centers in Serbia. The trial is no longer recruiting patients.