NeOnc Technologies Expands Global Clinical Trial Network with CBCC Global Research to Accelerate Study of Brain Cancer Treatments
NeOnc Technologies Holdings (NASDAQ: NTHI) has announced a strategic partnership with CBCC Global Research to expand its clinical trial network in India. The collaboration will establish 30 FDA-compliant research sites to accelerate patient enrollment for brain cancer treatments.
The primary focus is the NEO100-01 Glioblastoma (GBM) Phase 2a clinical trial, which evaluates the survival impact and tolerance of intranasal NEO100, an ultra-purified perillyl alcohol targeting IDH1 mutation in Grade 3 and 4 GBM tumors. The company aims to complete Phase 2 enrollment this year, with results expected 6-8 months afterward.
The trials will be conducted under Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) standards, with CBCC coordinating with NeOnc's U.S.-based CRO, Anova Enterprises, to ensure streamlined operations.
NeOnc Technologies Holdings (NASDAQ: NTHI) ha annunciato una partnership strategica con CBCC Global Research per espandere la sua rete di studi clinici in India. La collaborazione stabilirà 30 siti di ricerca conformi alla FDA per accelerare l'arruolamento dei pazienti per i trattamenti del cancro al cervello.
Il focus principale è il NEO100-01 Glioblastoma (GBM) studio clinico di Fase 2a, che valuta l'impatto sulla sopravvivenza e la tolleranza dell'NEO100 intranasale, un alcol perillyl ultra-puro che mira alla mutazione IDH1 nei tumori GBM di Grado 3 e 4. L'azienda punta a completare l'arruolamento della Fase 2 entro quest'anno, con risultati attesi 6-8 mesi dopo.
Gli studi saranno condotti secondo le normative delle Buone Pratiche Cliniche (GCP) e delle Buone Pratiche di Laboratorio (GLP), con CBCC che coordinerà con il CRO statunitense di NeOnc, Anova Enterprises, per garantire operazioni semplificate.
NeOnc Technologies Holdings (NASDAQ: NTHI) ha anunciado una asociación estratégica con CBCC Global Research para expandir su red de ensayos clínicos en India. La colaboración establecerá 30 sitios de investigación conformes a la FDA para acelerar la inscripción de pacientes para tratamientos de cáncer cerebral.
El enfoque principal es el ensayo clínico de Fase 2a NEO100-01 Glioblastoma (GBM), que evalúa el impacto en la supervivencia y la tolerancia del NEO100 intranasal, un alcohol perillyl ultra-puro que apunta a la mutación IDH1 en tumores GBM de Grado 3 y 4. La empresa tiene como objetivo completar la inscripción de la Fase 2 este año, con resultados esperados entre 6 y 8 meses después.
Los ensayos se llevarán a cabo bajo las Buenas Prácticas Clínicas (GCP) y las Buenas Prácticas de Laboratorio (GLP), con CBCC coordinando con el CRO de NeOnc en EE. UU., Anova Enterprises, para garantizar operaciones simplificadas.
NeOnc Technologies Holdings (NASDAQ: NTHI)는 CBCC Global Research와 전략적 파트너십을 체결하여 인도에서 임상 시험 네트워크를 확장한다고 발표했습니다. 이 협력은 뇌암 치료를 위한 환자 등록을 가속화하기 위해 FDA 준수 연구 사이트 30개를 설립할 것입니다.
주요 초점은 NEO100-01 교모세포종 (GBM) 2a 단계 임상 시험으로, IDH1 변이를 표적으로 하는 초정제된 페릴릴 알코올인 NEO100의 생존 영향과 내성을 평가합니다. 회사는 올해 2단계 등록을 완료하고 6-8개월 후에 결과를 기대하고 있습니다.
시험은 좋은 임상 관행(GCP) 및 좋은 실험실 관행(GLP) 기준에 따라 수행되며, CBCC는 NeOnc의 미국 기반 CRO인 Anova Enterprises와 협력하여 원활한 운영을 보장합니다.
NeOnc Technologies Holdings (NASDAQ: NTHI) a annoncé un partenariat stratégique avec CBCC Global Research pour étendre son réseau d'essais cliniques en Inde. La collaboration mettra en place 30 sites de recherche conformes à la FDA pour accélérer l'inscription des patients pour les traitements du cancer du cerveau.
Le principal objectif est l'
Les essais seront réalisés selon les Bonnes Pratiques Cliniques (GCP) et les Bonnes Pratiques de Laboratoire (GLP), avec CBCC coordonnant avec le CRO basé aux États-Unis de NeOnc, Anova Enterprises, pour garantir des opérations simplifiées.
NeOnc Technologies Holdings (NASDAQ: NTHI) hat eine strategische Partnerschaft mit CBCC Global Research angekündigt, um sein Netzwerk für klinische Studien in Indien auszubauen. Die Zusammenarbeit wird 30 FDA-konforme Forschungsstandorte einrichten, um die Patientenrekrutierung für Behandlungen von Hirntumoren zu beschleunigen.
Der Schwerpunkt liegt auf der NEO100-01 Glioblastom (GBM) Phase 2a klinischen Studie, die die Überlebensauswirkungen und die Verträglichkeit von intranasalem NEO100, einem ultra-reinen Perillylalkohol, der auf die IDH1-Mutation in GBM-Tumoren der Grade 3 und 4 abzielt, bewertet. Das Unternehmen plant, die Rekrutierung der Phase 2 noch in diesem Jahr abzuschließen, mit Ergebnissen, die 6-8 Monate später erwartet werden.
Die Studien werden nach den Good Clinical Practices (GCP) und Good Laboratory Practices (GLP) Standards durchgeführt, wobei CBCC mit dem in den USA ansässigen CRO von NeOnc, Anova Enterprises, koordiniert, um einen reibungslosen Ablauf zu gewährleisten.
- Expansion to 30 FDA-compliant trial sites in India will accelerate patient enrollment
- Phase 2a trial results expected within 6-8 months of enrollment completion
- Partnership with established CRO enhances trial execution capabilities
- Phase 2a trial still in enrollment phase, indicating several months before potential results
- Success of treatment efficacy and safety remains uncertain
Insights
NeOnc's new partnership with CBCC Global Research represents a strategic expansion of their clinical trial infrastructure that could meaningfully accelerate their development timeline. By gaining access to 30 FDA-compliant research sites in India, the company has positioned itself to overcome one of the biggest challenges in oncology trials: patient recruitment.
The focus on their NEO100-01 Phase 2a glioblastoma study is particularly significant. GBM is an aggressive brain cancer with dismal survival rates and treatment options. Their novel approach using intranasal NEO100 (ultra-purified perillyl alcohol) targeting IDH1 mutations in high-grade tumors represents an innovative therapeutic pathway.
What's most valuable here is the concrete timeline commitment: completing Phase 2 enrollment this year with data readout 6-8 months later. This accelerated timeline could potentially reduce their cash burn rate while expediting their path to market.
The partnership's emphasis on FDA alignment and adherence to GCP/GLP standards ensures the data generated will be acceptable to global regulators - critical for eventual approval pathways. The collaboration with their existing U.S. CRO (Anova) suggests a coordinated global strategy rather than simply outsourcing.
For a clinical-stage biotech, execution speed can be as important as the science itself. This move directly addresses execution by expanding recruitment capabilities while maintaining regulatory compliance - a balanced approach that could create significant value if successful.
WESTLAKE VILLAGE, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq Global Market: NTHI), a clinical-stage medical biotechnology company, today announced a strategic partnership with CBCC Global Research (CBCC), a premier full-service clinical research organization (CRO). This collaboration will expand NeOnc’s clinical trial capabilities in India, facilitating the advancement of its development-stage neuro-oncology treatment.
Through this partnership, NeOnc will initiate clinical trials across 30 FDA-compliant clinical research sites in India, increasing patient enrollment and accelerating development efforts for a novel therapy designed to target aggressive brain tumors.
CBCC will initially recruit for the NEO100-01 Glioblastoma (GBM) clinical trial, which is a Phase 2a study evaluating the survival impact and tolerance of intranasal NEO100, an ultra-purified perillyl alcohol with a focus on the IDH1 mutation component in Grade 3 and 4 GBM tumors.
“Our collaboration with CBCC represents an important milestone and step forward in our clinical development strategy,” said Amir Heshmatpour, Executive Chairman of NeOnc Technologies. “Conducting our trials in India allows us to accelerate patient recruitment, maintain regulatory compliance, and expedite the potential approval of these promising therapies for patients in need. We are focused on completing our Phase 2 NEO100-01 enrollment this year, with a readout expected 6 to 8 months after that.”
The FDA-aligned trials in India will be conducted under Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) standards, ensuring high-quality data generation and regulatory adherence. CBCC will oversee trial execution in coordination with NeOnc’s U.S.-based CRO, Anova Enterprises, ensuring streamlined operations.
“We are dedicated to advancing breakthrough therapies for brain cancer, and launching trials in India represents a critical step in that mission,” said Thomas Chen, MD, Ph.D., CEO of NeOnc Technologies. “By broadening our clinical reach, we are accelerating the path to market for our transformative treatments, while ensuring we reach a more diverse patient population.”
“India is emerging as a key hub for clinical research, and we are honored to support NeOnc in their mission to advance innovative neuro-oncology treatments,” said Manoj Vyas, CEO of CBCC Global Research. “With our deep expertise in clinical trial management and regulatory pathways, we are confident that this partnership will drive critical advancements in cancer therapeutics.”
This expansion underscores NeOnc Technologies’ commitment to accelerating the development of transformative therapies and improving patient outcomes worldwide. The company anticipates rapid enrollment and progress in these studies, bringing it closer to potentially delivering next-generation treatments for brain cancer and other challenging diseases.
About NeOnc Technologies Holdings, Inc.
NeOnc Technologies Holdings, Inc. (NASDAQ Global Market: NTHI) is a publicly traded clinical-stage life sciences company focused on the development and commercialization of central nervous system therapeutics designed to overcome 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. NeOnc’s NEO100™-01 and NEO100™-02 therapeutics are in Phase II, and the NEO100™-03 and NEO212™ therapeutics are in Phase I clinical trials, advancing under FDA Fast-Track and Investigational New Drug (IND) status.
For more information, visit www.neonctech.com.
About CBCC Global Research
CBCC Global Research is a full-service clinical Contract Research Organization (CRO) headquartered in Bakersfield, California, with operations across the U.S. and India. CBCC offers end-to-end services for clinical trials, including clinical operations, site management, safety management, clinical data management & statistical analysis, and medical & scientific writing. It specializes in supporting pharmaceutical, biotechnology, and medical device companies, particularly those in early stages of development, with regulatory and clinical trial needs.
CBCC has successfully executed over 100 clinical trials across 500+ sites. More than 70 pharmaceutical and biotech companies have availed CBCC’s services for their clinical development targeted for USFDA and EU submissions. CBCC has supported 10+ U.S.-based companies with clinical execution in both the U.S. and India. CBCC’s network sites have undergone over 50 audits by global regulatory agencies in the last 5 years, including the USFDA and EMA, demonstrating its commitment to quality and compliance.
For more information about CBCC Global Research, please visit www.cbcc.global.
Important Cautions Regarding Forward Looking Statements
This communication may contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Such statements, including, but not limited to completing enrollment this year, with a readout expected in 6 to 8 months after that, are based on management’s expectations, estimates, projections, and beliefs and involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially. More information can be found in the Risk Factors section of NeOnc’s SEC filings at www.sec.gov. NeOnc assumes no obligation to update these statements except as required by law.
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 timeline for NeOnc Technologies (NTHI) Phase 2a NEO100-01 trial completion?
How many clinical trial sites will NTHI establish in India through the CBCC partnership?
What type of brain cancer is NeOnc Technologies (NTHI) targeting with NEO100?
What quality standards will NTHI's clinical trials in India follow?
