Tiltan Pharma Ltd. has announced that it has commenced a Phase 2 clinical trial of its anti-angiogenic product TL-118 for the treatment of pancreatic cancer.
Following an approval by the Israeli Ministry of Health, Tiltan Pharma has launched the Phase 2 study in major oncology centers in Israel: The Tel Aviv Sourasky Medical Center, Hadassah Medical Center and the Sheba Medical Center at Tel-Hashomer.
The clinical trial will enroll 80 patients with newly diagnosed metastatic pancreatic cancer that have not yet been treated with chemotherapy. The trial will include two arms with 40 subjects each.
The control group will be treated with standard chemotherapy for pancreatic cancer, and the treated group will receive TL-118 in addition to standard-of-care chemotherapy.
Dr. Dan Goldstaub, Tiltan's Chief Operating Officer, said, "We are very excited with the results that we have seen on pancreatic cancer in animals and the initial safety and tolerability outcome in the first few human patients treated with TL-118 under compassionate use permission. We look forward to establishing TL-118's efficacy in pancreatic cancer in this clinical trial."
TL-118 was previously tested in a mouse model of pancreatic cancer. In pre-clinical trials, TL-118 monotherapy has been shown to inhibit tumor growth significantly, compared to the standard-of-care chemotherapy.
TL-118 therapy in combination with the standard-of-care chemotherapy has been shown to abolish the tumors in all treated animals.
TL-118 inhibits new blood vessel formations in tumors and thus inhibits their blood supply and growth.
TL-118 is an oral solution administered once daily and comprises a combination of agents that target different, non-overlapping aspects of the angiogenic process, all of which are approved by the regulatory authorities.
The therapy cycle is a carefully timed and balanced, patient-friendly, treatment regimen that maximizes the synergistic effect of these agents and combines them into a singularly safe and effective cancer treatment. Over 100 patients have been treated with TL-118 so far, for up to 3 years.
TL-118 was previously tested for safety in a Phase 1 clinical trial that was conducted in the Sheba Medical Center at Tel-Hashomer, Israel.
Thirty cancer patients were enrolled in the trial and the therapy was found to be safe and tolerable for the treatment of cancer patients and caused mostly minor clinically significant adverse reactions.
In parallel, TL-118 is being evaluated in parallel for the treatment of prostate cancer.
To date, about 50 patients have been recruited to a Phase 2 clinical trial that is being conducted in Israel and is under an active IND that was granted by the FDA.
Tiltan Pharma will be included as one of the portfolio companies of Integra Holdings, a holding company currently being formed by Yissum, the technology transfer company of the Hebrew University of Jerusalem.