The Weizmann Institute of Science in Israel has developed a novel prostate cancer treatment called Vascular Targeted Photodynamic therapy (VTP) with TOOKAD Soluble, in collaboration with Steba Biotech.
The therapy has now been granted approval in Mexico by Cofepris, the Mexican national health authority, for the treatment of early-stage prostate cancer. The treatment includes the drug TOOKAD Soluble and a laser.
A sucessful Phase III trial in South America (Panama, Mexico and Peru) with 80 patients confirmed the high occurrence of local cures and inconsequential side effects of VTP, already reported in Phase II clinical trials.
The Mexican marketing approval comes after the recent conclusion of a second Phase III clinical trial in Europe, a randomized pivot study comparing disease progression, erectile and urinary functions, and the cancer-free rate in patients receiving TOOKAD Soluble treatment and those under active surveillance with a two-year followup. More than 400 patients were enrolled in the trial at 43 hospitals in 11 European countries. The study is now under evaluation by the European Medicines Agency (EMA).
The therapy approved in Mexico combines an intravenous infusion with TOOKAD Soluble (first synthesized in Professor Avigdor Scherz’s lab from the photosynthetic pigment of certain aquatic bacteria that gain their energy from sunlight). The drug remains in the bloodstream of patients until it fully clears three to four hours later, so far showing no toxicity in trials. With the drug’s rapid clearance from the body and the use of near-infrared laser illumination, it is now possible to treat large, deeply embedded cancerous tumors with a minimally invasive procedure. And it spares nearby structures and their functions.
The approach follows a new paradigm developed by Professor Yoram Salomon, of the Biological Regulation Department, and Scherz, from the Plant and Environmental Sciences Department in the field of photodynamic therapy.
The latest marketing approval was granted to both elements of the therapy, the laser illumination device together with TOOKAD Soluble; the drug is called Vascular Targeted Photodynamic Therapy (VTP) with TOOKAD Soluble. The therapeutic procedure lasts nearly 90 minutes and because it is a minimally invasive technology offers a good alternative to patients diagnosed with early-stage prostate cancer. Patients can leave after a few hours and can return to their daily routine within a couple of days without the side effects generally associated with prostate removal by radiotherapy or surgery.
Prostate cancer patients have dramatically increased over the past two decades. Patients frequently face the dilemma of choosing between radical prostate removal treatments, with a high risk of remaining under active surveillance with an increased risk of further cancer progression, or morbidity. Researchers are hopeful that VTP with Tookad Soluble can provide a third, and better, option for these patients.