TOOKAD^® optic fibers illuminate only the cancerous regions, leaving healthy tissue alone

REHOVOT, ISRAEL—April 29, 2019—Steba Biotech, a privately owned company, has, in collaboration with scientists at the Weizmann Institute of Science, conducted extensive research and development on the prostate cancer treatment TOOKAD^® – and now has received marketing authorization to make it available in 31 European countries. Following this regulatory approval, the first patients are currently being treated in top Israeli, German, English, and Italian medical centers.

Moreover, a training center for urologists who want to use the method has been established at the Angers University Hospital, France, by Prof. Abdel-Rahmène Azzouzi.  

In the European Union, about 365,000 men are diagnosed with prostate cancer each year; some 77,000 die of the disease. Up to 35% of patients are diagnosed at the “low risk” early stages, and so have a much better prognosis than patients in the later, metastatic stages. But these men face a difficult choice: undergo invasive surgery or radiation, each of which may result in severe side effects such as erectile dysfunction and urinary incontinence, or else adopt the “active surveillance” approach of monitoring the cancer’s progression and delaying radical treatment. The latter tactic, while more risky and does not avoid cancer progression, can preserve quality of life for as long as possible. 

Vascular-targeted photodynamic therapy (VTP) with TOOKAD^® offers a middle way with minimally invasive treatment. It ablates only the prostate lobe that contains the cancerous tissue while preserving the integrity and functionality of the surrounding healthy tissue. The safety and efficacy of TOOKAD^® VTP were demonstrated in a randomized controlled trial of 413 patients across 10 countries. TOOKAD^® reduces the progression of cancer and the need for radical therapy, thus preserving erectile and urinary function in the overwhelming majority of the treated patients. Following the recent marketing authorization from the European Commission, Steba Biotech, which produces TOOKAD^®, is currently making the treatment available to a number of leading European medical centers.  

TOOKAD^® VTP was invented by Profs. Avigdor Scherz and Yoram Salomon of the Department of Plant and Environmental Sciences and the Department of Biological Regulation, respectively, at the Weizmann Institute of Science. It was translated to clinical use through an extensive collaboration with Steba Biotech, which undertook clinical development through the first successful Phase III clinical randomized trials for low-risk prostate cancer.

How does it work?

TOOKAD^® is a novel drug derived from the chlorophyll found in light-harvesting aquatic bacteria (bacteriochlorophyll). Upon intravenous administration, TOOKAD^® forms a complex with the protein serum albumin in the blood. The complex circulates for several hours before the body eliminates it. TOOKAD^® is inactive unless illuminated with non-thermal light; when activated by a laser light, it reacts with oxygen in the blood, converting it into active molecules called radicals. This initiates a cascade of biological events that results in a permanent blockade of the tumor’s blood vessels, ultimately killing the tumor cells. Within several hours, the tumor undergoes non-thermal necrosis and eradication. This means the treatment can be highly efficient with limited side effects; for example, the treatment avoids erectile and urinary dysfunction in the vast majority of patients, and there are no long-term issues related to the toxicity of the drug itself. This was confirmed in a four-year follow-up study published in The Journal of Urology.

Urologic surgeon Dr. Jonathan Coleman at Memorial Sloan Kettering Cancer Center discusses TOOKAD^® VTP

To administer the treatment, thin optic fibers connected to a near-infrared laser are inserted into the cancerous area in the prostate, with the help of magnetic resonance imaging (MRI) and ultrasound guidance. TOOKAD^® is intravenously administered for 10 minutes, under general anesthesia, after which the laser is turned on for another 22 minutes to activate the drug locally. In the currently approved focal therapy setting, TOOKAD^® VTP can be performed in an outpatient procedure that lasts around 90 minutes. Patients are released a few hours later ‒ up to a day ‒ and they can return to normal activities within a few days. This new, minimally invasive technology offers a unique alternative to patients diagnosed with early-stage prostate cancer.  

In the past few years, Steba Biotech has conducted extensive, successful clinical trials of TOOKAD^® for prostate cancer in leading hospitals in Europe and Latin America, as well as in the U.S. at Memorial Sloan Kettering Cancer Center in New York. Hundreds of men who have undergone TOOKAD^® treatment are cancer free or have control of their disease progression ‒ avoiding or delaying the need for more radical approaches and suffering few to no side effects from the treatment. TOOKAD^® is now approved for use in 31 European countries, Israel, and Mexico.

Yeda Research and Development Company, the Weizmann Institute’s technology transfer arm, has exclusively licensed the drug to Steba Biotech worldwide. Yeda and Steba Biotech have collaborated on developing the treatment for more than 20 years, and continue to collaborate today on exploring further cancer applications and getting the treatment to those who need it. 

Prof. Avigdor Scherz’s research is supported by the Thompson Family Foundation; the Leona M. and Harry B. Helmsley Charitable Trust; Sharon Zuckerman; Lord and Lady Sharp of Grimsdyke; the Samuil and Petr Polsky Prostate Cancer Research Fund; the Lotte S. and Felix Bilgrey Memorial Fund; and the Berdie and Irvin Cohen Weizmann Institute Research Fund.