Jerusalem, Israel – February 5, 2014 – Tiltan Pharma Ltd. today announced that it has raised $1.5 million for the completion of its on-going Phase 2 clinical study of TL-118, an anti-angiogenic therapy for the treatment of metastatic pancreatic cancer.
Half of the patients have already been enrolled in the Phase 2 clinical trial that is expected to include 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.
The study is ongoing in seven major oncology centers in Israel: Sheba Medical Center, the Tel Aviv Sourasky Medical Center, Hadassah Medical Center, Assaf HaRofeh Medical Center, the Rambam Medical Center, Soroka Medical Center and Hilel-Yaffe Medical Center and two in the U.S.: Emory University Hospital, Atlanta GA and White Plains New-York Medical Center.
Dr. Dan Goldstaub, Tiltan’s Chief Operating Officer, said, “We have just completed the enrollment of half of the patients in our Phase 2 anti-angiogenic therapy for the treatment of metastatic pancreatic cancer and hope to expedite recruitment of the remaining 40 patients with these additional funds. So far there were no safety or tolerability issues with the product and the accumulated data seems promising. We plan to complete enrollment within a year and hope to be able to present results by mid-2015.”
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 is patent protected in the US, Europe and major markets.
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.
About Anti-Angiogenic Therapy
Angiogenesis is the process by which new blood vessels are formed and is a hallmark capability of tumors. Anti-angiogenic therapy aiming to starve the tumor by cutting off its blood supply has emerged as a most promising strategy to inhibit tumor growth, since solid tumors rely on aggressive angiogenesis for their growth. In contrast to tumors, active angiogenesis does not usually take place in healthy tissues, highlighting the therapeutic potential and feasibility of anti-angiogenic therapy. TL-118 was developed to inhibit several, non-overlapping, pathways that are involved in angiogenesis.
About Pancreatic Cancer
Pancreatic cancer is responsible for approximately 6% of cancer-related deaths in the U.S. and is the fourth most common cause of cancer-related death for both genders combined. Recent estimates indicate that during 2013 more than 45,000 men and women in the U.S. alone were diagnosed with pancreatic cancer. More than 90% of those patients will eventually die from pancreatic cancer, and only 2% of those diagnosed with metastatic disease will live over 5 years.
About Tiltan Pharma
Tiltan Pharma Ltd. is a biotechnology company dedicated to the development and commercialization of its proprietary anti-angiogenic platform for the treatment of cancer and other indications. The Company is jointly owned by Yissum, the Technology Transfer Company of the Hebrew University, its entrepreneurs, Israeli investors and a group of Canadian investors. For additional information, please visit www.tiltanpharma.com
Dan Goldstaub, Ph. D.
Chief Operating Officer
Tiltan Pharma Ltd.
Global Media Liaison