Today July 2nd, 2019, SpectraCure AB (“Spec”) reports positive results and good clinical effects regarding safety in the company's clinical phase 1-study of patients with recurrent prostate cancer.
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.
For further information, please contact:
SpectraCure AB publ, CEO, Masoud Khayyami, phone: +46 (0) 70 815 21 90
Certified Adviser is G&W Fondkommission, e-mail: [email protected], phone: +46(0) 8 503 000 50
This information is information that SpectraCure AB is required to disclose under the EU Market Abuse Regulation. The information was provided, through the contact of the above contact person, for publication on July 2nd, 2019 15:15
SpectraCure in short
SpectraCure was founded in 2003 as a spin off from Lund University departments for medical laser applications and physics. The company focuses on cancer treatments using medical systems with laser light sources and reactive drugs, which is referred to as “Interstitial Photodynamic Therapy”, PDT, a treatment methodology suitable for internal solid tumours of various kind, e.g. prostate and abdominal salivary glands, but also other indications such as cancer tumours in the head and neck region
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