Fluoguide announce green light to proceed to the third dose level in the ongoing ph I/II trial in patients with high grade glioma. The results from the second dose level are in line with data from the first dose level in respect to safety and tolerability and lights was detected in 100% of patients. The data provide further validation of FG001 mode-of-action but we will await the complete dataset from the dose-escalation phase of the trial before further de-risking the case.

Reiterates previously communicated timeline
In conjunction with today’s press release, the company commented that patient recruitment in the coming months may be slowed down due to the COVID-19 pandemic, but that it still remains committed to the previously announced timeline at this stage; (1) Middle of 2021: Result of first phase (safety and selection of optimal dose), subject to number of cohorts; and (2) 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.

Link to the analysis