NeOnc Technologies has announced plans to develop its NEO100 intranasal perillyl alcohol for the treatment of high-grade gliomas in children. In 2016, NeOnc initiated a Phase 1/2a trial of NEO100 in adults with glioblastoma multiforme; according to clinicaltrials.gov, that study is expected to be completed in 2024. In 2020,the company published Phase 1 data for 12 patients, concluding that intranasal delivery was safe and that “Intranasal NEO100 has the potential to improve the outcome for recurrent glioblastoma.
As part of the new pediatric development program for NEO100, the company has hired Anova Enterprises to prepare applications to obtain FDA Fast Track and Rare Pediatric designations for the pediatric indication and to develop a clinical pediatric study plan. NEO100 already has Fast Track and orphan drug designations for the treatment of brain tumors in adults.
NeOnc CEO Thomas Chen commented, “While we recognize there can be significant differences between children and adults when it comes to the effectiveness of drug therapies, our success with NEO100 in adults leads us to believe that we may see similar results in pediatric patients diagnosed with pHGGS.”
Chen added, “In consultation with the FDA under NEO100’s OD and Fast-Track status, we expect to collect sufficient data that demonstrates the important therapeutic value of NEO100 for pHGGS. We believe our novel intranasal delivery approach for NEO100 makes a study in a pediatric population easier than other methods. Radiation and chemotherapy for children with high-grade gliomas is complex, time consuming and prognosis remains poor. All this underscores the importance of developing effective therapies that are less invasive and more tolerant for such populations.”
Anova CEO Chris Beardmore said, “It is an unfortunate fact that brain tumors are the most common solid tumor and the leading cause of death from cancer in children. While biological understanding of pediatric brain tumors has advanced rapidly, clinical trials have not kept pace. Our team applauds NeOnc for its commitment to bringing the promise of NEO100 to pediatric patients in need, and we are likewise committed to the success of this important program.”
Read the NeOnc Technologies press release.
