NeOnc Technologies Announces Near Completion of Phase I Enrollment for NEO212 Brain Cancer Therapy
Rhea-AI Summary
NeOnc Technologies Holdings (NASDAQ: NTHI) has announced near-completion of Phase I enrollment for its brain cancer therapy NEO212. The trial's final cohort (Cohort 5) is approaching completion of the dosing protocol, with the study designed for 5 escalating cohorts of 3 patients each.
NEO212 is a novel bio-conjugated therapeutic combining temozolomide (TMZ), the current standard-of-care chemotherapy for malignant gliomas, with perillyl alcohol (POH), a natural anti-cancer compound. This innovative formulation aims to overcome TMZ's limitations, including rapid bloodstream degradation, bone marrow suppression, and effectiveness in tumors with active MGMT DNA-repair enzyme expression.
The drug is engineered as a stable, orally bioavailable molecule, maintaining effectiveness in both MGMT-positive and MGMT-negative gliomas, potentially offering improved tumor targeting with reduced systemic side effects.
Positive
- Phase I trial nearing completion, demonstrating progress in clinical development
- Drug shows potential effectiveness in both MGMT-positive and negative gliomas, expanding market opportunity
- Novel formulation addresses multiple limitations of current standard-of-care treatment
Negative
- Still in early clinical development phase (Phase I)
- Efficacy data not yet available or disclosed
News Market Reaction – NTHI
In the trading session that priced this news, NTHI gained 3.84%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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CALABASAS, Calif., April 08, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI), a clinical-stage biopharmaceutical company focused on innovative treatments for central nervous system (CNS) cancers and disorders, today announced that its Phase I clinical trial of NEO212, a development-stage bio-conjugated therapeutic for brain cancer, is nearing full enrollment. The final cohort (Cohort 5) is expected to complete the study’s dosing protocol, marking a major milestone in the drug’s development timeline.
NEO212 is a proprietary conjugation of temozolomide (TMZ)—the current standard-of-care chemotherapy for malignant gliomas—and perillyl alcohol (POH), a naturally occurring compound with anti-cancer properties. While the use of TMZ alone has served as a frontline treatment for brain cancers for years, it suffers from key limitations such as rapid degradation in the bloodstream, bone marrow suppression due to toxic metabolites, and limited effectiveness in tumors with active MGMT DNA-repair enzyme expression. NEO212 is designed to address these concerns by creating a stable, orally bioavailable molecule that retains activity in both MGMT-positive and MGMT-negative gliomas.
“For patients battling brain cancer and other CNS diseases, the ability to deliver more drug to the tumor site with far fewer systemic side effects, could fundamentally shift how we treat these conditions,” said Amir Heshmatpour, Executive Chairman of NeOnc Technologies. “Our clinical results to date underscore the therapeutic potential of NeOnc’s delivery platform to redefine brain cancer treatment and open pathways for application across a broader range of CNS disorders.”
The NEO212 trial protocol includes five escalating cohorts (3 patients per cohort).
ABOUT NEONC TECHNOLOGIES HOLDINGS, INC.
NeOnc Technologies Holdings, Inc. is a clinical-stage life sciences company focused on the development and commercialization of central nervous system therapeutics that are designed to address the persistent challenges in overcoming the blood-brain barrier. The company’s NEO™ drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. These proprietary chemotherapy agents have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions.
For more about NeOnc and its pioneering technology, visit neonctech.com.
Important Cautions Regarding Forward Looking Statements
All statements other than statements of historical facts included in this press release are "forward-looking statements" (as defined in the Private Securities Litigation Reform Act of 1995). Generally, such forward-looking statements include statements regarding expectations, possible or assumed future actions, business strategies, events or results of operations, including statements regarding expectations or predictions or future financial or business performance or conditions and those statements that use forward-looking words such as "projected," "expect," "possibility" and "anticipate," or similar expressions. The achievement or success of the matters covered by such forward-looking statements involve significant risks, uncertainties, and assumptions. Actual results could differ materially from current projections or implied results. The Company cautions that statements and assumptions made in this news release constitute forward-looking statements and make no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time statements are made. The information set forth herein speaks only as of the date hereof. The Company and its management are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statements following the date of this news release, whether because of new information, future events or otherwise, except as required by law.
“NEO100” is a registered trademark of NeOnc Technologies Holdings, Inc.
Company Contact:
Patrick Walters
Chief Operations Officer
NeOnc Technologies Holdings, Inc.
info@neonc.com
Investor Relations:
Roger Pondel / Laurie Berman
PondelWilkinson Inc.
(310) 279-5980
rpondel@pondel.com
lberman@pondel.com
