Mexico Approves Early-Stage Prostate Cancer Treatment Recently Developed in Israel
Judy Siegel-Itzkovich - Jpost
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January 31, 2016
Mexico’s Cofepris health authority has authorized the use of an early-stage prostate cancer drug and laser therapy developed by the Weizmann Institute of Science in Rehovot in collaboration with Luxembourg’s Steba Biotech.
A successful Phase III clinical trial in Mexico, Peru and Panama of the treatment called TOOKAD Solublem, involved 80 patients. The results confirmed a high rate of local cures and minimal side effects already reported in Phase II trials.
Negative biopsies and maintenance of patients’ potency, continence and overall quality of life were evidence of the high success rate. There are not many other successful drugs against early-stage prostate cancer.
The approved therapy follows a new paradigm developed by Weizmann Prof. Yoram Salomon of the biological regulation department and Prof. Avigdor Scherz of the plant and environmental sciences department, in the framework of photodynamic therapy.
The Israeli-invented drug was first synthesized in Scherz’s lab from bacteriochlorophyll, the photosynthetic pigment of certain aquatic bacteria that draw their energy supply from sunlight.
The marketing approval in Mexico follows the recent completion of a second Phase III clinical trial in Europe. This randomized pivot study compared disease progression, the cancer-free rate and urinary and erectile functions in patients including those undergoing active surveillance, with a follow-up of two years.
It involved more than 400 patients at 43 hospitals in 11 European countries and is under evaluation by the European Medicines Agency (EMA).
The therapy involves an intravenous infusion of TOOKAD Soluble, immediately followed by near-infrared laser illumination through thin optic fibers inserted into the cancerous tissue, while doctors control the process by ultrasound.
The non-toxic drug remains in the patient’s blood for three or four hours. Confined illumination of the diseased tissue activates the drug, resulting in the extensive generation of short-lived toxic molecules. The highly reactive oxygen and nitric oxide radicals initiate speedy occlusion and destruction of the tumor’s blood vessels, followed by necrotic death of the entire tumor while nearby healthy structures and their functions are spared.
The use of near-infrared illumination, the rapid clearance of the drug from the body and the unique non-thermal mechanism of action, make it possible to safely treat large, deeply embedded cancerous tissue using a minimally invasive procedure.
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