Exousia Pro Issues and Update on its FDA Orphan Drug Status
Exousia Pro (OTC PINK:MAJI) has provided an update on its FDA Orphan Drug application for its Glioblastoma treatment using exosomes. The FDA has requested additional information from an ongoing UCF study, expected to be completed by mid-May 2025. The company reports positive preliminary anecdotal data, noting that certain animal cohorts are maintaining weight, indicating good health.
If granted, the Orphan Drug designation would provide significant benefits including:
- Seven-year marketing exclusivity
- Tax credits for qualified clinical testing
- PDUFA application fee waivers
- FDA development assistance
- Eligibility for research grants
The company's combination therapy aims to treat both methylated and unmethylated glioblastoma patients who are resistant to standard chemotherapy. The ongoing trial uses humanized mice and human donor glioblastoma, setting a higher standard than typical preclinical trials.
Exousia Pro (OTC PINK:MAJI) ha fornito un aggiornamento sulla sua domanda di farmaco orfano presso la FDA per il trattamento del glioblastoma utilizzando esomi. La FDA ha richiesto ulteriori informazioni da uno studio in corso dell'UCF, che si prevede sarà completato entro metà maggio 2025. L'azienda riporta dati preliminari aneddotici positivi, notando che alcuni gruppi di animali stanno mantenendo il peso, indicando una buona salute.
Se concessa, la designazione di farmaco orfano fornirebbe benefici significativi tra cui:
- Esclusiva di marketing per sette anni
- Crediti d'imposta per test clinici qualificati
- Esenzioni dalle tasse per la domanda PDUFA
- Assistenza nello sviluppo da parte della FDA
- Idoneità per sovvenzioni per la ricerca
La terapia combinata dell'azienda mira a trattare sia i pazienti con glioblastoma metilato che non metilato che sono resistenti alla chemioterapia standard. Lo studio in corso utilizza topi umanizzati e glioblastoma di donatori umani, stabilendo uno standard più elevato rispetto ai tipici studi preclinici.
Exousia Pro (OTC PINK:MAJI) ha proporcionado una actualización sobre su solicitud de medicamento huérfano ante la FDA para el tratamiento del glioblastoma utilizando exosomas. La FDA ha solicitado información adicional de un estudio en curso de la UCF, que se espera esté completado para mediados de mayo de 2025. La empresa informa datos anecdóticos preliminares positivos, señalando que ciertos grupos de animales están manteniendo peso, lo que indica buena salud.
Si se concede, la designación de medicamento huérfano proporcionaría beneficios significativos que incluyen:
- Exclusividad de marketing por siete años
- Créditos fiscales para pruebas clínicas calificadas
- Exenciones de tarifas de solicitud PDUFA
- Asistencia en el desarrollo por parte de la FDA
- Elegibilidad para subvenciones de investigación
La terapia combinada de la empresa tiene como objetivo tratar tanto a pacientes con glioblastoma metilado como no metilado que son resistentes a la quimioterapia estándar. El ensayo en curso utiliza ratones humanizados y glioblastoma de donantes humanos, estableciendo un estándar más alto que los ensayos preclínicos típicos.
Exousia Pro (OTC PINK:MAJI)는 엑소좀을 이용한 교모세포종 치료를 위한 FDA 고아약 신청에 대한 업데이트를 제공했습니다. FDA는 2025년 5월 중순까지 완료될 것으로 예상되는 UCF 연구에서 추가 정보를 요청했습니다. 회사는 긍정적인 초기 일화 데이터를 보고하며, 특정 동물 집단이 체중을 유지하고 있어 건강이 좋음을 나타냅니다.
승인될 경우, 고아약 지정은 다음과 같은 상당한 혜택을 제공합니다:
- 7년간의 마케팅 독점권
- 자격 있는 임상 시험에 대한 세금 공제
- PDUFA 신청 수수료 면제
- FDA 개발 지원
- 연구 보조금 자격
회사의 병합 요법은 표준 화학 요법에 저항력이 있는 메틸화 및 비메틸화 교모세포종 환자를 치료하는 것을 목표로 합니다. 진행 중인 시험은 인간화된 생쥐와 인간 기증자의 교모세포종을 사용하여 전형적인 전임상 시험보다 높은 기준을 설정합니다.
Exousia Pro (OTC PINK:MAJI) a fourni une mise à jour sur sa demande de médicament orphelin auprès de la FDA pour son traitement du glioblastome utilisant des exosomes. La FDA a demandé des informations supplémentaires d'une étude en cours de l'UCF, qui devrait être terminée d'ici la mi-mai 2025. L'entreprise rapporte des données anecdotiques préliminaires positives, notant que certains groupes d'animaux maintiennent leur poids, indiquant une bonne santé.
Si elle est accordée, la désignation de médicament orphelin offrirait des avantages significatifs tels que :
- Exclusivité de commercialisation pendant sept ans
- Crédits d'impôt pour les tests cliniques qualifiés
- Exemptions de frais de demande PDUFA
- Assistance au développement par la FDA
- Éligibilité pour des subventions de recherche
La thérapie combinée de l'entreprise vise à traiter à la fois les patients atteints de glioblastome méthylé et non méthylé qui sont résistants à la chimiothérapie standard. L'essai en cours utilise des souris humanisées et des glioblastomes de donneurs humains, établissant ainsi un standard plus élevé que les essais précliniques typiques.
Exousia Pro (OTC PINK:MAJI) hat ein Update zu seinem FDA-Antrag für ein Orphan Drug zur Behandlung von Glioblastomen mit Exosomen bereitgestellt. Die FDA hat zusätzliche Informationen von einer laufenden UCF-Studie angefordert, die voraussichtlich bis Mitte Mai 2025 abgeschlossen sein wird. Das Unternehmen berichtet von positiven vorläufigen anekdotischen Daten und stellt fest, dass bestimmte Tierkohorten ihr Gewicht halten, was auf eine gute Gesundheit hinweist.
Im Falle einer Genehmigung würde die Orphan Drug-Bezeichnung erhebliche Vorteile bieten, darunter:
- Siebeneinhalb Jahre Marketingexklusivität
- Steuergutschriften für qualifizierte klinische Tests
- Gebührenbefreiungen für PDUFA-Anträge
- Entwicklungsunterstützung durch die FDA
- Anspruch auf Forschungsstipendien
Die Kombinationstherapie des Unternehmens zielt darauf ab, sowohl Patienten mit methyliertem als auch mit nicht methyliertem Glioblastom zu behandeln, die resistent gegen die Standardchemotherapie sind. Die laufende Studie verwendet humanisierte Mäuse und menschliche Spender-Glioblastome und setzt damit einen höheren Standard als typische präklinische Studien.
- Potential FDA Orphan Drug designation could provide 7-year market exclusivity and significant financial benefits
- Preliminary animal study data shows positive health indicators
- Advanced trial methodology using humanized mice and human donor glioblastoma
- Treatment targets both methylated and unmethylated glioblastoma patients resistant to standard therapy
- FDA approval still pending additional data submission
- Study results and peer review not yet complete
- No concrete efficacy data presented yet
ORLANDO, FL / ACCESS Newswire / April 1, 2025 / MARIJUANA INC. (OTC PINK:MAJI), dba Exousia Pro, Inc., a clinical-stage biotech company using exosomes in the treatment of cancer and other maladies, is pleased to announce it has received a response from the FDA regarding its Orphan Drug application filed last year under Exousia AI for its Glioblastoma treatment using exosomes.
The FDA has been very responsive in its emails and phone calls and has requested additional information that is expected be provided this month from the study being conducted at UCF. The Company believes we have a high probability of receiving this designation. The UCF study is expected to be completed by the middle of May, at which time we will be able to release the results and seek to publish articles about the study.
To receive orphan drug designation, sponsors must submit a request to the FDA with a scientific rationale demonstrating a medically plausible basis for expecting the drug to be effective in treating the rare disease. This rationale is often supported by preclinical or clinical data. The FDA reviews these requests and, if the criteria are met, grants the orphan drug designation.
Orphan drug designation comes with several benefits for the sponsoring company, including:
Seven-year marketing exclusivity: Upon FDA approval, the first sponsor to receive approval for a designated orphan drug is granted seven years of exclusive marketing rights for that drug for the specified rare disease or condition. This exclusivity prevents the FDA from approving another product with the same active ingredient for the same use during that period, unless the subsequent product is shown to be clinically superior.
Tax credits: Sponsors can receive tax credits for qualified clinical testing expenses incurred in the United States.
Waiver of PDUFA application fees: The Prescription Drug User Fee Act (PDUFA) application fees, which can be substantial, are waived for orphan drugs.
Assistance in the drug development process: The FDA's Office of Orphan Products Development (OOPD) provides assistance and guidance to sponsors throughout the drug development process.
Eligibility for orphan products grants: Sponsors may be eligible to compete for research grants from the OOPD to support clinical studies for orphan drugs.
"Our multiple communications with the FDA regarding the orphan drug designation have been quite positive," stated Mike Sheikh, CEO of Exousia Pro, Inc. "Glioblastoma is a terrible disease and pretty much a death sentence for most. We believe our combination therapy has the potential to be effective and could make a huge difference for this patient population. We expect to treat both the methylated and unmethylated glioblastoma patients who are resistant to the standard chemotherapy regimen. The FDA is waiting for our preclinical data in order to make their assessment. The company is very encouraged by the preliminary anecdotal data that certain cohorts of animals in the study are not losing weight which is a sign of animal health. It's also worthwhile mentioning that the bar for this trial is much higher than a typical preclinical trial which is trying to cure mouse glioblastoma instead of our trial which uses humanized mice and human donor glioblastoma. When the study is finished and the peer-review is complete I expect this will change the paradigm in how we look at future glioblastoma treatment."
About us
Exousia Pro is a clinical-stage biotechnology company developing new ways to exploit the therapeutic potential of exosomes, initially focused 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. Ludwig Enterprises Inc.'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 Ludwig Enterprises, 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
When will Exousia Pro (MAJI) complete its UCF study for Glioblastoma treatment?
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What type of patients will MAJI's Glioblastoma treatment target?
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