SpectraCure AB (publ) provided update regarding clinical studies for the treatment of patients with recurrent prostate cancer. In the first part of the clinical studies, the company has achieved its goal of optimizing the drug dose and compiling the initial safety profile for the treatment of patients with recurrent prostate cancer. In the second part of the studies, work is underway to evaluate the effectiveness of the treatment, as well as continued monitoring of safety. A total of 17 patients have undergone treatment (10 at the Princess Margaret Cancer Centre in Toronto and 7 at University College London Hospitals NHS Foundation Trust (UCLH), London. The most recent patient treatment was conducted in January 2020 in London. The pandemic outbreak paused all clinical trials except those related to covid-19 at most hospitals around the world. In March 2020, a formal start-up meeting of the study was conducted at the Memorial Sloan Kettering Cancer Center in New York, but shortly thereafter, entry bans were introduced to the United States from Europe and New York was put under lock-down. The restrictions still apply, which prevents the company from making the necessary preparations at the Memorial Sloan Kettering Cancer Center. The team at Memorial Sloan Kettering is ready to begin patient treatments as soon as circumstances allow. At the Princess Margaret Cancer Centre in Toronto, cancer studies have been suspended for the time being. In addition, a two-week quarantine applies upon entry, which makes it impractical to work in Canada. The team at Princess Margaret Cancer Center is also ready to start patient treatment as soon as circumstances allow. At UCLH in London, the study resumed on October 8, 2020 and recruitment is now underway. Carrying out treatments is hampered by the general Covid situation in the UK, but the assessment of the company's partners at UCLH is that treatments should be able to be carried out shortly, as all prostate cancer treatments are offered. Evaluation of data In the safety evaluation, a side effect has been reported in one patient, classified as severe, at the Princess Margaret Cancer Centre, in the form of post-treatment pain. The symptoms were transient. The company, together with the doctors, assesses that the pain was caused by a procedural error during the procedure, which has since been corrected. No serious side effects have been reported at UCLH, nor any further at the Princess Margaret Cancer Centre. Effectiveness endpoints are based on evaluation of the effectiveness of the treatment using magnetic resonance imaging (MRI) images. In a series of meetings with the doctors November 2020 - February 2021, the results have been compiled and evaluated so far. The MRI images of tissue death show a good correlation with the dose plans from the company’s IDOSE system, which is the primary endpoint. This assessment is based on that tissue death seen on MRI images in the region where the tumour is situated is expected to mean that the tumour tissue also has been destroyed. The company ‘sand the doctors' assessment is thus that the results regarding the effect of the treatment so far follow expectations. The purpose of this kind of endpoint is to avoid assessments that take a long time, such as overall survival. This could ecrease the time to market. ontinued plan the company intends, as previously communicated, to apply for so-called accelerated approval for the method. This requires robust clinical data from phase 2. The advantage of this procedure is to be able to launch the product on the market in parallel with the implementation of a phase 3 study, instead of having to wait for results from phase 3 before market launch. In consultation with the company's regulatory advisors in the United States, the company estimates that the prospects of having an accelerated approval approved will increase if the company conduct an extendedphase 2b study to strengthen clinical outcomes. The company plans to implement this change by modifying the existing study with an extension of the number of patients and modification of the clinical protocol. Planning work on this has begun. The purpose is, among other things, to modify the study's endpoints so that they more clearly comply with what the FDA expects in an accelerated approval. This is planned to be done in dialogue with the FDA with the help of the company's regulatory consultants. While the work on the change of the clinical protocol is carried out, the work with the clinical study will continue under the current protocol, in order to collect more clinical data and further refine the treatment.