Tiltan Pharma Ltd. has announced that it has enrolled the first U.S. patient, at White Plains Hospital in Westchester County N.Y., in a Phase 2 clinical trial of its anti-angiogenic product, TL-118, for the treatment of metastatic pancreatic cancer.
The Phase 2 study is already ongoing in four major oncology centers in Israel: The Tel Aviv Sourasky Medical Center, Hadassah Medical Center, Assaf HaRofeh Medical Center and the Rambam Medical Center.
The clinical trial will enroll 80 patients with newly diagnosed metastatic pancreatic cancer that have not yet been treated with chemotherapy.
The trial includes two treatment groups with 40 subjects each. The control group is allocated to standard chemotherapy for pancreatic cancer, and the treatment group receives TL-118 in addition to standard-of-care chemotherapy.
Dr. Dan Costin, Director Westchester Institute for Treatment of Cancer and Blood Disorders, Co-Medical Director of White Plains Hospital Cancer Program and Principal Investigator for the TL-118 Study at White Plains Hospital, said: "We are happy to introduce this cutting edge therapy to our pancreatic cancer patients. Unfortunately, metastatic pancreatic cancer is a disease with very poor prognosis and we are urgently seeking new solutions that might enhance survival.
Dr. Costin added, “TL-118, which belongs to the family of angiogenesis inhibiting drugs demonstrated outstanding efficacy in pre-clinical studies, a promise we hope will be translated into significant clinical benefit to people suffering from pancreatic cancer."
Dr. Dan Goldstaub, Tiltan's Chief Operating Officer, said, "We are very pleased with the addition of the U.S. site to our study. The trial is advancing as planned, and we are satisfied with the recruitment rate. In Israel 15 patients were already enrolled, and we are certain that the new U.S. site will expedite the clinical trial. We are closely monitoring the efficacy, safety and tolerability of the product and so far we are happy with the outcome."
TL-118 was initially tested in a mouse model of pancreatic cancer. In these pre-clinical studies, TL-118 monotherapy has been shown to inhibit tumor growth significantly, compared to the standard-of-care chemotherapy.
Moreover, TL-118 therapy in combination with the standard-of-care chemotherapy has eliminated the tumors in all treated animals.
TL-118 inhibits new blood vessel formation in tumors and thus inhibits their blood supply and growth.
TL-118 is formulated as an oral solution administered once daily at home. It is comprised of 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 single, safe and effective cancer treatment. More than 100 cancer patients have been treated with TL-118 so far, for up to four 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.
Tiltan Pharma is one of the portfolio companies of Integra Holdings, a biopharmaceutical holding company founded by Yissum, the technology transfer company of the Hebrew University of Jerusalem.