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FluoGuide releases positive interim result of FG001-CT002, a phase IIa trial evaluating FG001 in patients with non-small cell lung cancer (NSCLC) undergoing surgery

Regulatory


November 6, 2022

Copenhagen, Denmark, 6 November 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) is pleased to announce that FG001 lights up in 5 out of 7 patients in an interim evaluation in the ongoing phase IIa trial in non-small cell lung cancer (NSCLC)

FluoGuide has evaluated data from 8 patients in the exploratory phase IIa trial in patients with non-small cell lung cancer (NSCLC) undergoing surgery. FG001 was well tolerated in all 8 patients.

One patient was not diagnosed with non-small cell lung cancer (NSCLC) but lung metastases from bladder cancer. In 5 of the 7 patients with NSCLC, FG001 lighted up the cancer. FG001 did also light up in the patient diagnosed with metastases from bladder cancer, however, this patient was excluded from the analysis as the patient did not have NSCLC.

Detection of light was made from the tissue identified macroscopically as cancer by the surgeon. At the end of the trial, the pathologists will histologically examinate the tissue that lights up to determine if the tissue samples contain cancer or normal tissue. Although this is an encouraging interim result, it is important to state that the final conclusion regarding the effect of FG001 will not be reached until after the histology examinations have been completed at end of the trial. The optimal dose in patients with NSCLC undergoing surgery is not yet established, which also means that the result in the optimal dose is anticipated to be similar or better.

Moving forward, the time of administration of FG001 prior to surgery will be investigated to select the optimal dosing in patient with lung cancer (NSCLC) undergoing surgery. The primary endpoint is sensitivity defined as the relative number of patients, whose cancer is illuminated by FG001. The trial is conducted at the Department of Cardiothoracic Surgery at the University Hospital, Rigshospitalet, in Denmark. The top line result is expected in H1 2023.

FluoGuide has selected lung cancer due to a high unmet need, evidence of uPAR overexpression and surgeon familiarity with using optical endoscopes during surgery.

“We are very pleased to see light with FG001 in lung cancer, supporting FG001 as a relevant product for guiding surgery beyond aggressive brain cancer” says Morten Albrechtsen, CEO and continues “It is important to understand that the trial is exploratory and aims to establish the dose and time of FG001 administration prior to surgery in patients with lung cancer.”

This disclosure contains information that Fluoguide is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 06-11-2022 15:54 CET.