This is a randomized, double-blind, placebo-controlled, 3 parallel arms (1:1:1 ratio), adjuvant trial to assess the efficacy and safety of two doses of 2-hydroxyoleic acid (LP561) versus placebo in patients with newly diagnosed GBM IDH wildtype. In all arms, patients will receive the SoC and will be randomized to receive either placebo (Arm A), low-dose of LP561 (Arm B) or high-dose of 2-OHOA (Arm C).
PIIB Protocol design and regulatory strategy agreed with EMA (Sep. 2018) CTA process ongoing in IL, SP, FR, UK, IT & NL. Up to 25 sites planned to recruit patients as of Q1 2019