Approval for clinical study at Skåne University Hospital

The regulatory authorities in Sweden have approved SpectraCure's clinical study of a new treatment for patients who suffer from prostate cancer recurrence. The recruitment of patients at Skåne University Hospital in Malmö is intended to start in March.

SpectraCure has previously signed an agreement with Skåne University Hospital regarding participation in the company's clinical study. The Swedish Medicines Agency and the Ethics Review Authority have approved the study. The study includes patients who have prostate cancer recurrence after previously undergoing radiotherapy. Recruitment of patients is intended to begin in March. The doctor responsible for the study is Anders Bjartell, a professor and senior physician at Skåne University Hospital. Co-examiner is Ymir Saemundsson, a urologist at Skåne University Hospital.

"We look forward to participating in the study and starting patient recruitment. In the future, we hope that SpectraCure's treatment will become an effective treatment option for patients suffering from prostate cancer recurrence," says Anders Bjartell.

Other hospitals that are a part of the study and where recruitment is ongoing are Princess Margaret Cancer Center in Toronto, University College London Hospital in London, and Memorial Sloan Kettering Cancer Center in New York. The study aims to investigate whether the treatment interstitial PDT with SpectraCure's Q-PRO® system and the light-activated drug verteporfin is a safe and effective treatment for prostate cancer recurrence.

Treatment of local recurrence in prostate cancer after radiotherapy is still controversial as many treatments cause serious side effects[1]. SpectraCure has developed a new medical device, Q-PRO®, with the potential to offer patients with recurred prostate cancer a focal treatment with few side effects. 

For further information: 
SpectraCure AB (publ) Masoud Khayyami, Acting CEO

SpectraCure is developing a treatment system for the elimination of internal solid cancer tumours. We are initially focusing on recurrent prostate cancer, with the hope of being able to treat other cancers such as primary prostate cancer, breast cancer, pancreatic cancer, and head and neck cancer in the future. The approach is based on a proprietary and patented treatment system, Q-PRO®, consisting of a hardware device, a laser unit, which performs PDT treatment and treats the prostate itself, combined with a software device, the patented IDOSE® dose planning platform. The method allows the laser light dose to be controlled so that the tumour is exposed to an optimal dose to achieve sufficient treatment effect. The treatment system has the potential to make interstitial PDT treatment accurate, precise, and safe for every patient. The goal is that in addition to being tumour free, the patients will be able to maintain their quality of life, with limited side effects. We are conducting clinical trials as an important part of the continued development of the company's treatment system. 

The company is listed in the Premier segment of the Nasdaq First North Growth Market with G&W Fondkommission as Certified Adviser, and trades under the short name SPEC.

[1] Valle, L. F., Lehrer, E. J., Markovic, D., Elashoff, D., Levin-Epstein, R., Karnes, R. J., Reiter, R. E., Rettig, M., Calais, J., Nickols, N. G., Dess, R. T., Spratt, D. E., Steinberg, M. L., Nguyen, P. L., Davis, B. J., Zaorsky, N. G., & Kishan, A. U. (2021). A Systematic Review and Meta-analysis of Local Salvage Therapies After Radiotherapy for Prostate Cancer (MASTER). European urology, 80(3), 280–292.