SpectraCure has conducted a clinical phase 1-study on treatment of patients with recurrent prostate cancer with the company’s photodynamic therapy (PDT) technology.
A total of 11 patients with recurrent prostate cancer were treated with SpectraCure’s technology in the phase 1-study, with promising and positive results. This means that the study’s primary endpoint on safety was achieved. However, the effect on the cancer tumour will be continuously evaluated during the continued follow-up of the patients by PSA tests, magnetic camera examination and tissue samples, in accordance with a pre-established protocol. The result is that the safety requirements are achieved, and the clinical program can continue with further clinical studies in phase-2. End-point regarding safety in the study means that adverse events have been evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and that eventual exposure of treatment effects to adjacent tissues in the prostate has been evaluated by a MR examination one week after treatment. This data has been assessed by a Data Monitoring Committee, with at least one independent auditing expert.
In addition to the currently reported results, all patients treated with SpectraCure’s technology are monitored over a 12-month period following treatment. This part of the study is ongoing, and the results are expected to be reported after the last patient’s biopsy in phase-1.
-We are very happy about the good results in the phase-1 study! The fantastic collaboration between our partner clinics and employees has ensured that the study could be performed according to schedule and with clear results, comments Masoud Khayyami, CEO.
In the end of 2018, as previously announced, the company entered the final phase of the planning for a subsequent phase 2-study. In April 2019, SpectraCure has initiated patient treatments in the phase 2-study together with the clinical partners, Princess Margaret Cancer Center in Toronto, University College London Hospital in London, and the University of Pennsylvania Hospital in Philadelphia.
The purpose of the phase 2-study is to show that the method is safe to use and that it has clinical effect, with a larger statistical basis than in the phase 1-study.