Date: 2016-01-25
Type of information: Completion of the trial
phase: 3
Announcement: completion of the trial
Company: Steba Biotech (Luxembourg)
Product: Tookad® (padeliporfin di-potassium)
Action
mechanism: photosensitizer/photodynamic therapy. Tookad® is a first-in-class photosensitizer derived from palladium-substituted bacteriochlorophyll and developed in collaboration with the Weizmann Institute. It was designed to address limitations of previous attempts in photodynamic therapies. Through its high solubility and activation with low energy, near-infrared light, Tookad® enables highly localized vascular occlusion that triggers targeted necrosis of tumor lesions, while sparing surrounding healthy tissue. Steba Biotech, a privately-owned, biotechnology company headquartered in Luxembourg with offices in France, Israel, Switzerland, and the US, is also pursuing early stage studies of Tookad® in esophageal cancer, urothelial carcinoma, advanced prostate cancer, renal carcinoma, and triple negative breast cancer in collaboration with Memorial Sloan Kettering Cancer Center, the Weizmann Institute, and Oxford University.
Disease: low-risk prostate cancer
Therapeutic area: Cancer - Oncology
Country: Belgium, Finland, France, Germany, Italy, The Netherlands, Spain, Sweden, Switzerland, UK
Trial
details: The PCM301 study is a European, prospective, multicenter, open label, randomized, controlled study that compared TOOKAD® versus active surveillance. The study enrolled 413 low-risk prostate cancer patients (clinical stage up to cT2a, PSA?10 ng/ml, absence of Gleason pattern 4 or 5, at least one positive cancer core with 3 to 5mm cancer involvement or 2-3 positive cancer cores with no more than 5mm cancer involvement) in 47 centers across 10 European countries. 206 patients were included in the TOOKAD® arm (4mg/kg infusion and 200J/cm light activation) and 207 in the active surveillance arm. Patients were then followed-up during a 2-year period with measure of PSA level, urinary, and erectile functions every 3 months, plus biopsies at 12 and 24 months. The first co-primary endpoint compared the rates of absence of definite cancer based on biopsy at 24 months between TOOKAD® and active surveillance. The second coprimary endpoint compared the rates of treatment failure associated with observed progression of disease between TOOKAD® and active surveillance. Progression of disease to moderate- or high-risk was defined as the observation of 4 or more positive cores over the entire period, or at least one positive core longer than 5mm, or Gleason pattern 4 or 5, or PSA>10ng/mL in 3 consecutive measures, or any T3 stage prostate cancer, or any metastasis, or any prostate cancerrelated death. (NCT01310894)
Latest
news: * On January 25, 2016, Steba Biotech, a privately owned biotechnology company focused on the development of innovative and minimally invasive photodynamic therapies and systems to treat cancers, today announced completion of PCM301, its European Phase 3 clinical trial of Tookad® (padeliporfin di-potassium), a novel investigational treatment for localized prostate cancer and other solid tumors. PCM301 is the first prospective randomized controlled trial evaluating the efficacy and safety of a focal therapy in prostate cancer. The data will be presented at the upcoming European Association of Urology scientific meeting in March. Based on these results, Steba Biotech has submitted on January 7, 2016 a Marketing Authorization Application (MAA) to the European Medicine Agency (EMA) for Tookad®. The MAA requests EMA approval of Tookad® for the treatment of localized prostate cancer.
