Medicenna Therapeutics Corp. (MDNA) (MDNA.TO) has been advised to proceed with a hybrid phase III registration trial of MDNA55 in recurrent glioblastoma patients with no mutation in 1DH1/1DH2 genes, following a recent End of phase II meeting with the FDA.
The proposed phase III clinical trial design includes the MDNA55 arm, standard of care (SOC) arm and an additional matched external control arm. The primary endpoint of the trial is overall survival, which will be determined by a 1:1 analysis of the MDNA55 arm versus the pooled control arm, which will consist of external controls and subjects randomized to SOC.
The hybrid trial design not only allows for robust overall survival analysis but also significantly reduces the number of trial participants randomized to standard of care therapies, according to the company.
The company also revealed that the FDA has indicated a willingness to potentially consider an interim analysis of the trial if certain conditions are met.
MDNA closed Thursday's trading at $3.95, down 12.03%.
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