Tiltan Pharma Announces Enrollment of First U.S. Patient in a Phase 2 Clinical Trial of TL-118, Anti-Angiogenic Treatment for Metastatic Pancreatic Cancer

White Plains Hospital is the first U.S. site
to offer this innovative treatment to cancer patients

Jerusalem, Israel – Nov 13, 2012 – Tiltan Pharma Ltd. today 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.

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 2011, approximately 44,000 men and women in the United States 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

About White Plains Hospital

White Plains Hospital (WPH) is a 292-bed voluntary, not-for-profit health care organization with the primary mission of offering high quality, acute health care and preventive medical care to all people who live in, work in or visit Westchester County and its surrounding areas. Centers of Excellence include the Dickstein Cancer Treatment Center, The William & Sylvia Silberstein Neonatal & Maternity Center, The Ruth and Jerome A. Siegel Stroke Center and The Westchester Orthopedic Institute. The Hospital is a ten-time winner of the Consumer Choice Award, an honor given to the nation’s top hospitals by the National Research Corporation, and received Magnet designation in 2012 from the American Nurses Credentialing Center. WPH is a member of the New York-Presbyterian Healthcare System and the Stellaris Health Network, Inc.  For additional information, visit http://www.wphospital.org.

Company contact:
Dan Goldstaub, Ph. D.
Chief Operating Officer
Tiltan Pharma Ltd.
[email protected]

Media contact:
Tsipi Haitovsky
Global Media Liaison
[email protected]
+972-52-5989892