NeOnc Technologies Holdings, Inc. received FDA approval to expand its ongoing NEO100-01? Phase 2a clinical trial to include Recurrent Grade III Astrocytoma with Isocitrate Dehydrogenase 1 (IDH1) mutation. The FDA approval expands the current clinical trial, ?An Open-Label, Phase 1/2a Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent Grade IV Glioma,?

from only Recurrent Grade IV tumors that more often affects senior adults (typically 50-80 years of age) to a younger patient population (typically ages 30-40) that are more often affected by Grade III. NeOnc looks to build upon the published results from its Phase 1 clinical safety study which demonstrated greater survival rates with NEO100-01, and particularly with patients who received additional treatments cycles and those with the IDH1 marker, as well as against current standard-of-care treatments. An estimated 1 million Americans are living with a primary brain tumor, with an estimated 26,940 new malignant tumor cases diagnosed in the U.S. last year, according to the National Brain Tumor Society.

For patients with malignant brain tumors, the five-year relative survival rate following diagnosis remains at less than 36%. Recurrent Grade III Astrocytoma with IDH1 mutations are also known to manifest as aggressively as its Grade IV/IDH1 counterparts, which further highlights the importance of the study expansion. The biotechnology strides generated by NeOnc's patented NEO platform are the result of more than a decade of research at the University of Southern California (USC) by Dr. Chen and his medical and scientific teams. Dr. Chen has been leading the company?s Phase I and II clinical trials.

By enabling better drug delivery to the brain cancer, the company believes its NEO technology can turn existing FDA-approved drugs into more effective treatments across a full range of central nervous system (CNS) disorders. The company is developing several additional proprietary chemotherapy agents that have demonstrated positive effects in laboratory tests on other various types of cancers. The World Health Organization categorizes Astrocytoma into four grades.

The grades depend on how fast the Astrocytoma grows and the likelihood that it will spread to or infiltrate nearby brain tissue. Grade I Astrocytoma is the mildest form of brain cancer which most often affects children and teens. Grade II Astrocytoma most often affect adults between the ages 20 and 60.

These types of cancers tend to spread to nearby brain tissue, so surgery alone might not be enough to treat them. Grade III Astrocytoma most often affect adults between 30 and 60 years of age. Grade III often presents as a progression from Grade II and is more aggressive.

Surgery alone never cures these tumors; they require radiation and almost always require chemotherapy. Grade IV Astrocytoma, also known as Glioblastomas, are the most common type of brain cancer in adults and account for 24% of all brain tumors. They are also the most dangerous and aggressive type of Astrocytoma and are known to spread quickly.

They can either present as a cancerous progression from a previously existing lower-grade Astrocytoma (10% of cases) or begin as a Grade IV tumor (90% of cases).