According to NeOnc Technologies, the FDA has approved an expansion of an ongoing Phase 2a trial of the company’s NEO100 intranasal perillyl alcohol to include patients with recurrent grade 3 astrocytoma with isocitrate dehydrogenase 1 (IDH1) mutation. NeOnc announced the initiation of the trial, which initially focused on treatment of grade 4 gliomas, in May 2016. The company says that the addition of grade 3 tumors will likely add more younger patients, aged 30-40, to the study.
In March 2023, NeOnc announced its intention to develop NEO100 for the treatment of high-grade gliomas in children. At that time, the company said that it intended to apply for FDA Fast Track and Rare Pediatric Disease designations.
NeOnce CEO Thomas Chen commented, “This significant approval advances the research and development of our NEO technology platform and its ability to produce novel drugs and delivery methods designed to address the persistent challenges with overcoming the blood-brain barrier. Moreover, it opens the field for us to investigate how NEO100-01 could be safe and efficacious for younger populations before their cancers potentially worsen to Grade 4.”
Chen added, “As we continue to consult with the FDA under its orphan drug and Fast Track status, we expect to collect sufficient data that demonstrates the important therapeutic value of our four leading drug candidates. We believe our novel intranasal delivery approach will enable studies in difficult groups, including the pediatric population. . . . This underscores the importance of us developing effective therapies that are less invasive and more tolerable for challenged populations.”
Read the NeOnc Technologies press release.
