British MHRA approves pancreas trial

SpectraCure AB, a Swedish medical device company, has received approval to begin testing the Interstitial PhotoDynamic Therapy (IPDT) system on pancreatic cancer patients in the UK. Photodynamic therapy comprises a light-activated drug and a matching light source. SpectraCure-AB-device-The light-activated drug is administered to the patient prior to surgery and absorbed by the tumor. When light is delivered to the region of the tumor, it activates the light sensitive drug which destroys the cancerous tumor cells through apoptosis or necrosis.

Photodynamic therapy has been around for some time, but is frequently limited in its use to deeper lying tumors due to the poor penetration depth of the light source and difficulties in controlling the dose. SpectraCure’s IPDT system aims to overcome these problems by delivering the laser light source through fiber optic cables which also monitor the dose by feeding back optical data from the treated region.

To date, tests on prostate cancer patients in Sweden have shown that the method works for internal tumors, and in the Spring a clinical study on recurrent prostate cancer will begin in the US and Canada pending approvals.SpectraCure has applied to the British Medicines and Healthcare products Regulatory Agency (MHRA) to co-sponsor a clinical study on pancreatic cancer in the UK. On the February 15th MHRA approved the notification.

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