The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to FluoGuide’s optical imaging agent, FG001.

The FDA designation applies to the use of FG001 during surgeries of more aggressive gliomas – World Health Organization (WHO) Grade III and IV gliomas. Malignant gliomas are fast-growing brain tumours that start in glial cells (supporting cells of the brain and spinal cord).

FG001 is a fluorophore that targets urokinase-type plasminogen activator receptor (uPAR), a cell surface protein usually found in metastatic cells. The agent is administered into a patient’s vein before surgery and ‘lights up’ the cancer cells during surgery. The highlighted section can then be resected without involving any healthy tissue.

FluoGuide expects the agent uptake to be easier as it has the same spectral specifications as an already approved medical diagnostic dye, indocyanine green. FG001 can, therefore, be used on current imaging equipment without adaptation.

Different approaches to increasing the safety of brain surgeries have been explored in recent years. In July, Stryker launched its cranial guidance software, Q Guidance System, to help surgeons plan and carry out cranial procedures. In September, Zeta launched a mixed-reality cranial navigation system to provide neurosurgeons with millimetric accuracy during cranial surgeries.

“We have completed enrolment and treatment in our Phase llb clinical trial of FG001 and are now looking forward to top-line results, which we expect by the end of November,” said FluoGuide CEO, Morten Albrechtsen.

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“We are now discussing plans for next stage clinical development of FG001 in aggressive brain cancer with regulators, so we can ensure the most effective route to approval, supported by the necessary data.”

FG001 is being evaluated in a randomised control Phase IIb trial (FG001-CT-001) which compares the imaging agent with the standard brain tumour surgery reagent, 5-aminolevulinic acid (5-ALA), and white light.

FluoGuide was quick to highlight that although the trial compares the two imaging agents, it is not powered to demonstrate statistical significance for comparison between FG001, white light or 5-ALA.

The Danish company is also investigating FG001 imaging agent in non-small cell lung cancer (FG001-CT-02), squamous cell carcinoma of the head and neck (FG001-CT-03), and meningiomas and low-grade gliomas (FG001-CT-04).