NeOnc Technologies’ Perillyl Alcohol (NEO100™) Granted Rare Pediatric Disease Designation by FDA for Treatment of Pediatric-Type Diffuse High-Grade Gliomas
Westlake Village, CA, March 31, 2025 – NeOnc Technologies Holdings, Inc. (NASDAQ Global Market: NTHI), a leading clinical-stage medical biotechnology company, is proud to announce that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to perillyl alcohol (NEO100™) for the treatment of pediatric-type diffuse high-grade gliomas. This designation is given to investigational drugs that show promise in treating life-threatening or debilitating conditions that primarily affect fewer than 200,000 people in the United States.
About Pediatric-Type Diffuse High-Grade Gliomas
Pediatric-type diffuse high-grade gliomas are a serious and life-threatening condition that primarily affects children and adolescents. These tumors are characterized by their rapid growth and aggressive nature. Despite advances in research and treatment, the prognosis for children diagnosed with these tumors remains poor, with a five-year survival rate of only about 30%.
About Perillyl Alcohol (NEO100™)
Perillyl alcohol (NEO100™) is a naturally occurring monoterpenoid compound that has shown potential in inhibiting the growth of cancer cells, including those found in pediatric-type diffuse high-grade gliomas. NeOnc Technologies Holdings has been conducting clinical trials to evaluate the safety and efficacy of NEO100™ in the treatment of these tumors. The RPDD designation is a significant milestone in the development of this investigational drug.
Impact on Individuals and Families
For families with children diagnosed with pediatric-type diffuse high-grade gliomas, the RPDD designation of perillyl alcohol (NEO100™) is a ray of hope. This designation provides several benefits, including:
- Expedited Review: The FDA will prioritize the review of NeOnc Technologies Holdings’ regulatory filings for NEO100™ for the treatment of pediatric-type diffuse high-grade gliomas.
- Orphan Drug Tax Credits: NeOnc Technologies Holdings may be eligible for tax credits for clinical testing and development of NEO100™.
- Grants and Funding: NeOnc Technologies Holdings may be eligible for research grants and funding from the FDA Office of Orphan Products Development and other organizations.
Impact on the World
The RPDD designation of perillyl alcohol (NEO100™) for the treatment of pediatric-type diffuse high-grade gliomas is not only a significant milestone for NeOnc Technologies Holdings but also for the global community. With an estimated 3,000 new cases diagnosed each year in the United States alone, this condition affects countless families around the world. The development of effective treatments for pediatric-type diffuse high-grade gliomas has the potential to:
- Improve Survival Rates: The development of effective treatments for pediatric-type diffuse high-grade gliomas could significantly improve the survival rates for children and adolescents diagnosed with these tumors.
- Reduce Suffering: Effective treatments could help reduce the physical and emotional suffering of children and their families.
- Advance Medical Research: The development of NEO100™ for the treatment of pediatric-type diffuse high-grade gliomas could pave the way for further research and advancements in the field of pediatric oncology.
Conclusion
The Rare Pediatric Disease Designation granted by the FDA to NeOnc Technologies Holdings for perillyl alcohol (NEO100™) is a significant step forward in the development of an investigational drug for the treatment of pediatric-type diffuse high-grade gliomas. This designation provides numerous benefits to NeOnc Technologies Holdings and, most importantly, to the families affected by this life-threatening condition. With the potential to improve survival rates, reduce suffering, and advance medical research, the development of NEO100™ holds great promise for the future.
As we continue to follow the progress of NeOnc Technologies Holdings and their efforts to bring NEO100™ to market, we remain hopeful for a future where effective treatments are available for pediatric-type diffuse high-grade gliomas. The journey towards finding a cure is long and arduous, but with the support of the scientific community, regulatory agencies, and families affected by this condition, we can make a difference.
