And give worship to the Lord your God, who will send his blessing on your bread and on your water; and I will take all disease away from among you. Exodus 23:25 (The Israel Bible™)
A new treatment for prostate cancer in men who don’t want to undergo radical surgery because of the side effects and are afraid to just remain under their doctor’s observation has been developed by Israeli scientists.
Steba Biotech, a privately-owned company, in collaboration with scientists at the Weizmann Institute of Science in Rehovot, has conduct extensive research and development on the treatment named TOOKAD, and has received marketing authorization to make it available in 31 European countries. Following approval from the European Medicines Agency, the first patients are now being treated in leading Israeli, German, British and Italian medical centers.
In addition, a training center for urologists who want to use the treatment method has been established at the University Hospital of Angers in France.
Every year in the European Union alone, about 365,000 men are diagnosed with prostate cancer; about 77,000 of them die of the disease.
Up to 35% of patients are diagnosed at the “low risk” in the early stages of prostate cancer; these patients have a much better prognosis than patients in the later metastatic stages. But these men face a difficult choice: either undergo invasive surgery or radiation, both of which may result in such severe side effects as erectile dysfunction and urinary incontinence; or else adopt the “active surveillance” approach, monitoring the cancer’s progression and delaying radical treatment. This approach, while being riskier and without preventing the progression of the cancer, can preserve their quality of life for as long as possible.
Now, Vascular Targeted Photodynamic therapy (VTP) with TOOKAD offers a middle way with minimally invasive treatment. It removes 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 shown in a randomized controlled trial of 413 patients (level-one evidence), across 10 countries (according to an article in The Lancet Oncology). The Israeli-developed treatment was shown to reduce the progression of cancer and the need for radical therapy, thus preserving of erectile and urinary function in the overwhelming majority of the treated patients.
TOOKAD VTP was invented by Prof. Avigdor Scherz and Prof. Yoram Salomon of the Weizmann Institute’s Plant and Environmental Sciences and Biological Regulation Departments. 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.
TOOKAD is a novel drug derived from the chlorophyll found in light-harvesting aquatic bacteria (bacteriochlorophyll). When given intravenously, the drug combines with the protein serum albumin in the blood, and the complex circulates for several hours before being eliminated.
The drug is inactive unless illuminated with non-thermal light; when activated by a laser light, TOOKAD 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 that initiate a chain of biological events that kill 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.
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 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 protocol, TOOKAD VTP can be performed in an outpatient procedure lasting around an hour and a half. Patients are released a few hours later ‒ up to a day ‒ and they can return to normal activities within few days. This new, minimally invasive technology offers a unique alternative to patients diagnosed with early-stage prostate cancer.
Steba has conducted extensive, successful clinical trials of TOOKAD for prostate cancer in leading hospitals in Europe and in Latin America, as well as at Memorial Sloan-Kettering, in New York City. 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 of the treatment, itself.
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 over 20 years and continue to collaborate today on exploring further cancer applications and getting the treatment to those who need it.