Exousia Pro Finishes Preclinical Trial for Glioblastoma Ahead of Schedule - Bolstering Orphan Drug Application
Exousia Pro has completed its preclinical trial for glioblastoma treatment ahead of schedule, strengthening its FDA Orphan Drug Application. The company employed an advanced humanized mouse model using actual human glioblastoma tumor cells, setting it apart from 90% of typical preclinical studies.
The trial involved 32 mice divided into four groups testing different treatment combinations: control, temozolomide (TMZ) alone, exosome treatment alone, and TMZ-exosome combination therapy. The 14-day tumor establishment period was followed by a seven-day treatment phase.
CEO Mike Sheikh highlighted that their unique exosomal-based therapy approach allows for targeted treatment through a singular process where cells perform the loading work. Earlier in vitro studies showed promising results when combining their exosome therapy with minimal chemotherapy, particularly in eliminating cancer stem cells - a major obstacle in glioblastoma treatment.
The company expects to receive comprehensive trial results by mid-to-late May 2025, which will support their FDA Orphan Drug Application.
Exousia Pro ha completato in anticipo la sua sperimentazione preclinica per il trattamento del glioblastoma, rafforzando la sua domanda per il riconoscimento come Farmaco Orfano presso la FDA. L'azienda ha utilizzato un avanzato modello murino umanizzato con cellule tumorali umane di glioblastoma, distinguendosi dal 90% degli studi preclinici tradizionali.
La sperimentazione ha coinvolto 32 topi divisi in quattro gruppi per testare diverse combinazioni di trattamento: controllo, temozolomide (TMZ) da solo, trattamento con esosomi da solo e terapia combinata TMZ-esosomi. Dopo un periodo di 14 giorni per l'insediamento del tumore, è seguita una fase di trattamento di sette giorni.
Il CEO Mike Sheikh ha sottolineato che il loro approccio unico basato sulla terapia con esosomi consente un trattamento mirato tramite un processo singolo in cui le cellule svolgono il lavoro di carico. Studi in vitro precedenti avevano mostrato risultati promettenti combinando la loro terapia con esosomi a una chemioterapia minima, in particolare nell'eliminazione delle cellule staminali tumorali, un ostacolo importante nel trattamento del glioblastoma.
L'azienda prevede di ricevere i risultati completi della sperimentazione entro la metà o la fine di maggio 2025, che supporteranno la loro domanda per il Farmaco Orfano presso la FDA.
Exousia Pro ha completado antes de lo previsto su ensayo preclínico para el tratamiento del glioblastoma, fortaleciendo su solicitud de Medicamento Huérfano ante la FDA. La compañía utilizó un avanzado modelo de ratón humanizado con células tumorales humanas de glioblastoma, diferenciándose del 90% de los estudios preclínicos típicos.
El ensayo involucró a 32 ratones divididos en cuatro grupos para probar diferentes combinaciones de tratamiento: control, temozolomida (TMZ) sola, tratamiento con exosomas solo y terapia combinada TMZ-exosomas. Tras un período de 14 días para el establecimiento del tumor, siguió una fase de tratamiento de siete días.
El CEO Mike Sheikh destacó que su enfoque único basado en la terapia con exosomas permite un tratamiento dirigido a través de un proceso único donde las células realizan la carga. Estudios in vitro anteriores mostraron resultados prometedores al combinar su terapia con exosomas con quimioterapia mínima, especialmente en la eliminación de células madre cancerosas, un gran obstáculo en el tratamiento del glioblastoma.
La compañía espera recibir los resultados completos del ensayo para mediados o finales de mayo de 2025, que respaldarán su solicitud de Medicamento Huérfano ante la FDA.
Exousia Pro는 교모세포종 치료를 위한 전임상 시험을 예정보다 일찍 완료하여 FDA 희귀의약품 신청을 강화했습니다. 회사는 실제 인간 교모세포종 종양 세포를 사용한 고급 인간화 마우스 모델을 적용하여 일반 전임상 연구의 90%와 차별화했습니다.
이번 시험에는 32마리의 쥐가 네 그룹으로 나뉘어 다양한 치료 조합을 테스트했습니다: 대조군, 테모졸로마이드(TMJ) 단독, 엑소좀 단독 치료, TMJ-엑소좀 병용 치료. 14일간의 종양 형성 기간 후 7일간 치료 단계가 진행되었습니다.
CEO 마이크 셰이크는 독특한 엑소좀 기반 치료법이 세포가 직접 적재 작업을 수행하는 단일 과정을 통해 표적 치료를 가능하게 한다고 강조했습니다. 이전 인 비트로 연구에서는 최소한의 화학요법과 엑소좀 치료를 결합했을 때 암 줄기 세포 제거에 특히 효과적이라는 유망한 결과가 나타났습니다. 이는 교모세포종 치료의 주요 장애물입니다.
회사는 2025년 5월 중순에서 말 사이에 전임상 시험의 종합 결과를 받아 FDA 희귀의약품 신청을 지원할 예정입니다.
Exousia Pro a terminé en avance son essai préclinique pour le traitement du glioblastome, renforçant ainsi sa demande de Médicament Orphelin auprès de la FDA. La société a utilisé un modèle avancé de souris humanisée avec de véritables cellules tumorales humaines de glioblastome, ce qui la distingue de 90 % des études précliniques classiques.
L'essai a impliqué 32 souris réparties en quatre groupes testant différentes combinaisons de traitement : contrôle, témozolomide (TMZ) seul, traitement par exosomes seul, et thérapie combinée TMZ-exosomes. Après une période d'établissement tumorale de 14 jours, une phase de traitement de sept jours a suivi.
Le PDG Mike Sheikh a souligné que leur approche unique basée sur la thérapie par exosomes permet un traitement ciblé via un processus unique où les cellules effectuent le chargement. Des études in vitro antérieures avaient montré des résultats prometteurs en combinant leur thérapie par exosomes avec une chimiothérapie minimale, notamment pour éliminer les cellules souches cancéreuses, un obstacle majeur dans le traitement du glioblastome.
La société prévoit de recevoir les résultats complets de l'essai d'ici la mi-fin mai 2025, ce qui soutiendra leur demande de Médicament Orphelin auprès de la FDA.
Exousia Pro hat seine präklinische Studie zur Behandlung von Glioblastom vorzeitig abgeschlossen und damit seine FDA-Antragstellung für ein Orphan Drug gestärkt. Das Unternehmen setzte ein fortgeschrittenes humanisiertes Mausmodell mit echten menschlichen Glioblastom-Tumorzellen ein, was es von 90 % der üblichen präklinischen Studien unterscheidet.
Die Studie umfasste 32 Mäuse, die in vier Gruppen aufgeteilt wurden, um verschiedene Behandlungskombinationen zu testen: Kontrolle, Temozolomid (TMZ) allein, Exosom-Behandlung allein und TMZ-Exosom-Kombinationstherapie. Nach einer 14-tägigen Tumoransiedlungsphase folgte eine siebentägige Behandlungsphase.
CEO Mike Sheikh betonte, dass ihr einzigartiger exosombasierter Therapieansatz eine gezielte Behandlung durch einen einzigen Prozess ermöglicht, bei dem die Zellen die Beladearbeit übernehmen. Frühere in-vitro-Studien zeigten vielversprechende Ergebnisse bei der Kombination ihrer Exosom-Therapie mit minimaler Chemotherapie, insbesondere bei der Eliminierung von Krebsstammzellen – einem großen Hindernis bei der Glioblastombehandlung.
Das Unternehmen erwartet, die umfassenden Studienergebnisse bis Mitte bis Ende Mai 2025 zu erhalten, die ihren FDA-Orphan-Drug-Antrag unterstützen werden.
- Early completion of glioblastoma preclinical trial, accelerating FDA Orphan Drug Application timeline
- Advanced humanized mouse model using actual patient tumor cells, increasing trial credibility and results translatability
- In vitro studies showed significant cancer stem cell elimination when combining exosomal therapy with minimal chemotherapy
- Innovative single-process exosome targeting and loading method potentially solving production inefficiencies
- Potential FDA Orphan Drug designation could provide regulatory and financial benefits
- Higher costs associated with using humanized mouse model compared to standard preclinical studies
- Final comprehensive trial results not yet available - pending until mid-late May 2025
- Currently trading on OTCPINK market, indicating lower-tier exchange listing
- Rigorous humanized mouse model enhances credibility and translatability of results
- Key preclinical data to support FDA Orphan Drug Application
- In vitro success signals potential for exosome-based therapy breakthrough
ORLANDO, FL / ACCESS Newswire / April 29, 2025 / MARIJUANA INC. (OTCPINK:MAJI), dba Exousia Pro, Inc., a clinical-stage biotech company utilizing exosomes in therapies helpful in the treatment of cancer and other diseases, is pleased to announce the early completion of its preclinical trial for glioblastoma, a highly aggressive brain cancer. This milestone strengthens the company's FDA Orphan Drug Application and positions Exousia Pro to become a leader in innovative cancer treatments.
Nearly
The trial involved 32 mice implanted with glioblastoma patient-derived tumor cells into the brain. After a 14-day tumor establishment period, the mice were randomized into four cohorts: control, conventional temozolomide (TMZ) treatment alone, exosome treatment alone, and a TMZ-exosome combination therapy. Following seven days of treatment, evaluations focused on key metrics, including tumor size, and body weight changes to assess treatment efficacy and overall mouse health. Tumor size reduction will be critical in supporting the company's FDA Orphan Drug Application, while detailed brain slices immunohistochemical analyses are expected to reveal the underlying therapeutic effects. A comprehensive report is expected by mid-to-late May 2025.
"This preclinical trial could alter the trajectory of exosomal-based therapies which has seen relatively low adoption due to production and manufacturing inefficiencies," said Mike Sheikh, CEO of Exousia Pro. "We can target and load the exosome in a singular process whereby the cell does all the work for us. Our in vitro studies demonstrated that our exosomal therapy, combined with minimal chemotherapy, significantly enhances the elimination of cancer stem cells-the primary barrier to effective glioblastoma therapy. If our preclinical results validate or exceed these findings, Exousia Pro could achieve global recognition and transform the standard of care for glioblastoma patients.
The company anticipates key positive preclinical data for submission to the FDA in order to advance the Orphan Drug Application, potentially unlocking significant regulatory and financial benefits.
About us
Exousia Pro is a clinical-stage biotechnology company developing new ways to exploit the therapeutic potential of exosomes via the targeted delivery of nuclear material. Initially the therapeutic focus will be on oncology, the company's patented manufacturing process utilizes plant-based materials to create exosomes used in a number of commercial applications from dermatology to dentistry. The company's proprietary loading technology can infuse a range of molecules from drugs to DNA.
For more information, please visit: www.exousiapro.com
SAFE HARBOR
Forward-looking statements in this release are made under the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. Exousia Pro's forward-looking statements do not guarantee future performance. This news release includes forward-looking statements concerning the future level of business for the parties. These statements are necessarily subject to risk and uncertainty. Actual results could differ materially from those projected in these forward-looking statements due to certain risk factors that could cause results to differ materially from estimated results. Management cautions that all statements as to future results of operations are necessarily subject to risks, uncertainties, and events that may be beyond the control of Exousia Pro, Inc., and no assurance can be given that such results will be achieved. Potential risks and uncertainties include, but are not limited to, the ability to procure, appropriately price, retain, and complete projects and changes in products and competition.
CONTACT:
Marijuana, Inc.
www.Exousiapro.com
Twitter: @Exousia_Pro
Investor Relations
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SOURCE: Marijuana Inc.
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FAQ
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