British Medicines Agency MHRA approves clinical study

SpectraCure's application for completing parts of an ongoing Phase 1 clinical trial in the UK has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The study is the same Phase 1 study conducted by SpectraCure for the treatment of prostate cancer at the Princess Margaret Cancer Center in Toronto, Canada. With the approval, SpectraCure intends to launch the ongoing Phase 1 study at a further clinic for treatments, University College London (UCL) Hospital.

As previously announced, SpectraCure has signed an agreement with UCL Hospital to complete parts of the study.

The treatment method tested in the study, called photodynamic tumor therapy (PDT), where the patient is given a light activated drug that accumulates in the tumor. When the cancer tissue is illuminated by laser light of the correct wavelength, the drug activates and knocks out the tumor. The target group for the study is patients who have had recurrence of prostate cancer after radiotherapy.

The approval from MHRA means that the Authority approves the clinical protocol for the ongoing study, together with the use of SpectraCure's medical technology system, SpectraCure P18 with IDOSE®. We are looking forward to commencing our clinical studies at UCL Hospital shortly.

For further information, please contact:
SpectraCure AB publ, CEO, Masoud Khayyami, phone: +46 (0) 70 815 21 90

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 February 28th, 2018.

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