As previously disclosed, the US authority FDA has approved SpectraCure's new and revised study protocol for the clinical study on patients with recurrent prostate cancer. The protocol has also been approved by the UK and Canadian authorities. The new protocol expands the inclusion criteria for Gleason score, which allows a wider range of candidates to participate in the upcoming phase III study. In addition, the upper limit on prostate volume has been removed, which is positive since the results indicate that the method is not restricted by prostate volume. This revision increases the pool of patients to recruit from even further.
– I am very pleased that the UK and Canadian authorities have approved our new extended study protocol. We have now taken another important stride in our clinical effort, and the approval widens the range of patients that can be recruited for treatment, says SpectraCure's CEO, Masoud Khayyami.
SpectraCure's cooperating hospitals in the US, UK and Canada are beginning to return to normal operation after the corona crisis, and there is now a relatively large number of prospective patients available for recruitment to the continued clinical study.
For further information, please contact:
SpectraCure AB (publ), CEO, Masoud Khayyami, telephone: +46(0) 70 815 21 90
See also: www.spectracure.com
SpectraCure was founded in 2003 as a spin off from Lund University and LTH Faculty of Engineering in Sweden. The company focuses on cancer treatments with medical systems based on laser light sources, connected to the tumour by way of optical fibers, in combination with a photoreactive drug. The method is referred to as Interstitial Photodynamic Therapy, PDT. The treatment is suitable for internal solid tumours of various kind, such as prostate and pancreatic tumours, but also for example for cancers of the head and neck. www.spectracure.com.
