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A phase 2a clinical trial of NEO100-01 is continuing to recruit patients with malignant gliomas, with full enrollment expected in September.
A phase 2a clinical trial of NEO100-01 is continuing to recruit patients with malignant gliomas, with full enrollment expected in September.
Six patients are left to complete the 25-patient enrollment target of the trial, according to a news release from clinical-stage biopharmaceutical company NeOnc Technologies Holdings, Inc.
NEO100 is described in the news release as a highly purified version of perillyl alcohol administered intranasally, or through the nose, which is intended to bypass the blood-brain barrier. NEO-100-01, according to the news release, is the first intranasal therapy of its kind of be evaluated in the treatment of malignant gliomas, specifically targeting IDH1-mutant grade 3 and 4 astrocytomas.
Perillyl alcohol, as explained by Memorial Sloan Kettering Cancer Center in New York City on its website, is a natural substance isolated from essential oils of lavender, peppermint, spearmint cherries, celery seeds and other plants, and laboratory evidence suggests it interferes with the replication of dividing cells.
“We believe our intranasal delivery mechanism can present a breakthrough in central nervous system oncology, potentially offering a practical and elegant route to circumvent the blood-brain barrier,” said Dr. Thomas Chen, CEO and Chief Scientific Officer at NeOnc Technologies, in the news release. “Early data from our Phase 1 study provides support that patients with IDH1 mutations experienced extended survival post-recurrence with minimal side effects. We are optimistic that this approach could transform treatment outcomes for this patient population.”
Blood-brain barrier: a network of blood vessels and tissue that lets substances such as water, oxygen, carbon dioxide and general anesthetics pass into the brain and keeps substances such as bacteria and many anticancer drugs out of the brain, as explained by the National Cancer Institute.
In the study, according to its listing on clinicaltrials.gov, NEO100 will be self-administered by patients four times a day for a 28-day treatment cycle until disease progression, death or patient withdrawal from the study.
The study, according to the listing, is currently being conducted at seven locations across the United States. Trial locations include the University of Southern California in Los Angeles, the Georgia Cancer Center at Augusta University in Augusta, Ochsner Health in New Orleans, Atlantic Health at Overlook Medical Center in Summit, New Jersey, Northwell Health in New York City, Wake Forest University Health Sciences in Winston-Salem, North Carolina and the Cleveland Clinic.
“Reaching near full enrollment in the NEO100-01 trial, with only six patients remaining, is a positive and exciting development,” said NeOnc Technologies’ executive chairman, Amir Heshmatpour, in the news release. “Our team believes we can meet the [Food and Drug Administration (FDA)’s] efficacy endpoints and deliver a positive outcome for patients battling these devastating tumors.”
The FDA has already granted NEO100 Orphan Drug Designation and Fast Track Status as well as Rare Pediatric Disease Designation.
Orphan Drug Designation, which is granted to a drug or biological product to prevent, diagnose or treat a rare disease or condition, qualifies a drug’s sponsor for incentives including tax credits for qualified clinical trials, exemption from user fees and seven years of potential market exclusivity after approval, as explained by the FDA on its website.
Additionally, Fast Track is a process that is designed to facilitate the development and expedite the review of drugs that would treat serious conditions and fill an unmet medical need in order to get new drugs to the patients earlier, according to the FDA.
And, with the Rare Pediatric Disease Designation, NeOnc Technologies may be eligible for a Rare Pediatric Disease Priority Review Voucher if NEO100’s marketing application is approved by the FDA. This program incentivizes the development of new treatments for rare pediatric diseases by offering an expedited regulatory review process.
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