FluoGuide gets green light to proceed to second dose level with FG001 in the ongoing clinical phase I/II trial in patients with high grade glioma
Regulatory
December 17, 2020
Evaluation of the results from the first dose level of FG001, including data from three patients, has been finalized and reported to the dose escalation committee. The dose escalation committee has earlier today been given green light to proceed and enroll the first patient on the second dose level.
The first dose was chosen substantially below the expected optimal dose as a safety precaution when dosing a new product to humans for the first time. It is nevertheless encouraging that no safety issues were identified, which is in line with the result of the pre-clinical program. It is important to underline that the first phase of the trial (up to 24 patients) must be completed and analyzed before any conclusions on tolerability and safety profile can be drawn.
Despite the very low dose tested in this first dose group of patients, light was detected in two out of the three patients. Although this is encouraging, it is important to state that it is not yet possible to conclude anything on the effect of FG001 on the basis of these findings. Additional results from patients dosed with higher levels of FG001 are needed to evaluate the robustness and further analysis is thereafter needed to confirm that the tissue that lights up is actually cancer and tissue that does not light up is free of cancer, which is determined by the patologist at the end of the first phase of the trial.
The clinical phase I/II trial initiation has taken slightly longer than anticipated. However, the set-up is now fully implemented and the following dose groups are expected to be completed faster assuming no impact from the ongoing COVID-19 pandemic takes place. The following timeline is anticipated by FluoGuide: (i) Middle of 2021: Result of first phase (safety and selection of optimal dose); and (ii) Second half of 2021: Efficacy result from the second phase, including estimation of the potential magnitude of benefit of FG001 in guiding surgery of patients with high grade glioma.
“We are very pleased to see the trial advancing so well, which has only been possible due to hard work delivered by the team at Rigshospitalet, FluoGuide and many others”, says Morten Albrechtsen, CEO, and continues “We need to interpret the initial results with caution, but it is encouraging”.
FluoGuide A/S is obliged to publish this information in accordance with the EU Market Abuse Regulation. The information was provided by the contact person set out above for publication on 17 December 2020.