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Also known as Perillyl alcohol
NEO100 · 3 trials · 10 indications
Progression free survival
Assess the safety and tolerability of increasing dose levels of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs
| Arm | Type | Description |
|---|---|---|
| Patients with high-grade meningioma | EXPERIMENTAL | 30 patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma |
| Phase 1b safety, dose finding, brain-tumor delivery, and pharmacokinetics of IN NEO100 | EXPERIMENTAL | Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid). The study will use a modified Fibonacci dose titration design, followed by a standard dose escalation design. * Cohort 1: 192 mg NEO100, QID on a 28-day cycle * Cohort 2: 288 mg NEO100, QID on a 28-day cycle * Cohort 3: 384 mg NEO100, TID on a 28-day cycle; * Cohort 4 (ceiling dose): 576 mg NEO100, BID on a 28-day cycle. Patients undergoing surgical or needle biopsy (only when clinically indicated) will receive a minimum of four days IN NEO100 treatment prior to the procedure. |
| NEO100 Phase 1 | EXPERIMENTAL | Intranasal delivery of NEO100 (perillyl alcohol) four times a day, escalation up to four different doses to determine maximum tolerated dose. |
| NEO100 Phase 2A | EXPERIMENTAL | Intranasal delivery of NEO100 (perillyl alcohol) four times a day. Treatment of total of 25 patients at maximum tolerated dose. |
| Name | Type | Description |
|---|---|---|
| NEO100 | DRUG | NEO100 is a purified form of perillyl alcohol. |
| Perillyl alcohol | DRUG | Intranasal administration |
Inclusion Criteria Patient must: 1. Have histologically confirmed WHO Grade II or III meningioma that is residual, progressive or recurrent following at least minimally safe resection and radiation therapy. Metastatic meningiomas are allowed. 1. Residual disease is defined as residual measurab...
NEO100 is an investigational small molecule being studied in oncology for Glioblastoma Multiforme, pediatric tumors of the central nervous system, and residual, progressive or recurrent Grade II or III meningioma. It is not yet approved for commercial use and remains in clinical development.
NEO100 is being developed by NeOnc Technologies Holdings, Inc., which trades under the ticker NTHI. The company sponsors the clinical programs evaluating the drug across adult high-grade glioma and pediatric central nervous system tumor indications in the United States.
NEO100 is in Phase 1 and Phase 2 clinical development. The Phase 1 program includes a pediatric brain tumor study and a recurrent or progressive high-grade glioma study, while a Phase 2 study is evaluating the drug in high-grade meningioma. It is investigational and has not received FDA approval.
NEO100 is being studied in NCT06357377, a Phase 1 trial in pediatric brain tumors, NCT05023018, a Phase 2 trial in residual, progressive or recurrent Grade II or III meningioma, and NCT02704858, a Phase 1 trial in recurrent or progressive Grade III or IV IDH1 mutated glioma. All three trials are recruiting or active.
Yes, NEO100 is also known as perillyl alcohol. Researchers and investors may encounter the asset under either name, but both refer to the same small molecule being developed by NeOnc Technologies Holdings, Inc. for central nervous system tumor indications.
NEO100 has received Orphan Drug and Fast Track designations from the FDA. These designations support the development of therapies for serious conditions, but they do not constitute approval. The drug remains investigational and is still being evaluated in clinical trials.