NeOnc Technologies Announces Near Completion of Phase I Enrollment for NEO212 Brain Cancer Therapy
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.
NeOnc Technologies Holdings (NASDAQ: NTHI) ha annunciato il quasi completamento dell'arruolamento della Fase I per la sua terapia contro il cancro al cervello NEO212. L'ultima coorte dello studio (Coorte 5) si avvicina al completamento del protocollo di dosaggio, con lo studio progettato per 5 coorti crescenti di 3 pazienti ciascuna.
NEO212 è un nuovo trattamento bio-coniugato che combina temozolomide (TMZ), l'attuale chemioterapia standard per i gliomi maligni, con alcol perillilico (POH), un composto naturale anti-cancro. Questa formulazione innovativa mira a superare le limitazioni del TMZ, inclusi la rapida degradazione nel flusso sanguigno, la soppressione del midollo osseo e l'efficacia nei tumori con espressione attiva dell'enzima di riparazione del DNA MGMT.
Il farmaco è progettato come una molecola stabile, bio-disponibile per via orale, mantenendo l'efficacia sia nei gliomi positivi che negativi per MGMT, offrendo potenzialmente un targeting tumorale migliorato con effetti collaterali sistemici ridotti.
NeOnc Technologies Holdings (NASDAQ: NTHI) ha anunciado el casi completado reclutamiento de la Fase I para su terapia contra el cáncer cerebral NEO212. La última cohorte del estudio (Cohorte 5) se acerca a la finalización del protocolo de dosificación, con el estudio diseñado para 5 cohortes en aumento de 3 pacientes cada una.
NEO212 es una nueva terapia bio-conjugada que combina temozolomida (TMZ), la quimioterapia estándar actual para gliomas malignos, con alcohol perilílico (POH), un compuesto natural anti-cáncer. Esta formulación innovadora tiene como objetivo superar las limitaciones del TMZ, incluyendo la rápida degradación en el torrente sanguíneo, la supresión de la médula ósea y la efectividad en tumores con expresión activa de la enzima de reparación del ADN MGMT.
El fármaco está diseñado como una molécula estable, bio-disponible por vía oral, manteniendo efectividad tanto en gliomas positivos como negativos para MGMT, ofreciendo potencialmente una mejor focalización tumoral con efectos secundarios sistémicos reducidos.
NeOnc Technologies Holdings (NASDAQ: NTHI)는 뇌암 치료제 NEO212의 1상 등록이 거의 완료되었다고 발표했습니다. 시험의 마지막 집단(5집단)이 투약 프로토콜 완료에 가까워지고 있으며, 이 연구는 각각 3명의 환자로 구성된 5개의 증가하는 집단을 위해 설계되었습니다.
NEO212는 악성 신경교종에 대한 현재 표준 치료인 테모졸로마이드 (TMZ)와 자연 항암 화합물인 페릴릴 알코올 (POH)를 결합한 새로운 생물학적 접합 치료제입니다. 이 혁신적인 제형은 TMZ의 한계를 극복하는 것을 목표로 하며, 여기에는 혈류에서의 빠른 분해, 골수 억제 및 활성 MGMT DNA 복구 효소 발현이 있는 종양에서의 효과가 포함됩니다.
이 약물은 안정적이고 경구 생체 이용 가능한 분자로 설계되어 MGMT 양성 및 음성 신경교종 모두에서 효과를 유지하며, 잠재적으로 시스템적 부작용을 줄이면서 종양 표적화를 개선할 수 있습니다.
NeOnc Technologies Holdings (NASDAQ: NTHI) a annoncé l'achèvement presque total du recrutement de la Phase I pour sa thérapie contre le cancer du cerveau NEO212. La dernière cohorte de l'étude (Cohorte 5) est sur le point de terminer le protocole de dosage, l'étude étant conçue pour 5 cohortes croissantes de 3 patients chacune.
NEO212 est un nouveau traitement bio-conjugué combinant temozolomide (TMZ), la chimiothérapie standard actuelle pour les gliomes malins, avec alcool périllylique (POH), un composé naturel anti-cancer. Cette formulation innovante vise à surmonter les limitations du TMZ, y compris la dégradation rapide dans le flux sanguin, la suppression de la moelle osseuse et l'efficacité dans les tumeurs avec expression active de l'enzyme de réparation de l'ADN MGMT.
Le médicament est conçu comme une molécule stable, bio-disponible par voie orale, maintenant son efficacité tant dans les gliomes positifs que négatifs pour MGMT, offrant potentiellement un ciblage tumoral amélioré avec des effets secondaires systémiques réduits.
NeOnc Technologies Holdings (NASDAQ: NTHI) hat die nahezu abgeschlossene Rekrutierung der Phase I für seine Therapie gegen Gehirntumoren NEO212 angekündigt. Die letzte Kohorte der Studie (Kohorte 5) nähert sich dem Abschluss des Dosierungsprotokolls, wobei die Studie für 5 ansteigende Kohorten von jeweils 3 Patienten konzipiert ist.
NEO212 ist eine neuartige bio-konjugierte Therapie, die Temozolomid (TMZ), die derzeitige Standard-Chemotherapie für bösartige Gliome, mit Perillylalkohol (POH), einem natürlichen Anti-Krebs-Verbindung, kombiniert. Diese innovative Formulierung zielt darauf ab, die Einschränkungen von TMZ zu überwinden, einschließlich der schnellen Zersetzung im Blutstrom, der Unterdrückung des Knochenmarks und der Wirksamkeit bei Tumoren mit aktiver MGMT-DNA-Reparatur-Enzymexpression.
Das Medikament ist als stabile, oral bioverfügbare Molekül konzipiert, das sowohl in MGMT-positiven als auch in MGMT-negativen Gliomen wirksam bleibt und potenziell eine verbesserte Tumoransprache bei reduzierten systemischen Nebenwirkungen bieten kann.
- 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
- Still in early clinical development phase (Phase I)
- Efficacy data not yet available or disclosed
Insights
NeOnc Technologies' announcement represents a modest positive milestone in their clinical development pathway for NEO212, their brain cancer therapeutic. Completing enrollment for the final cohort in a Phase I trial is a necessary step forward, though still early in the overall drug development process.
The company's approach combines temozolomide (the current standard therapy) with perillyl alcohol to potentially address key limitations of conventional treatment. Most notably, NEO212 aims to overcome issues with TMZ including rapid degradation, bone marrow toxicity, and resistance in tumors expressing MGMT repair enzymes.
For context, this Phase I study follows a standard dose-escalation design with 5 cohorts of 3 patients each, primarily evaluating safety and determining appropriate dosing rather than efficacy. After Phase I completion, the company would typically need to conduct Phase II and potentially Phase III studies before seeking regulatory approval - a process that could take several more years.
While this progress demonstrates the company is executing on its clinical development plan, investors should note that early-stage trial enrollment completion represents a small step in a lengthy development timeline. The absence of preliminary safety or efficacy data in this announcement is standard at this stage but provides new information to substantively revalue the company's prospects.
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
FAQ
What is the current status of NeOnc Technologies' NEO212 Phase I trial for brain cancer?
How does NTHI's NEO212 differ from traditional temozolomide brain cancer treatment?
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