Exousia Pro Issues and Update on its FDA Orphan Drug Status
Rhea-AI Summary
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.
Positive
- 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
Negative
- FDA approval still pending additional data submission
- Study results and peer review not yet complete
- No concrete efficacy data presented yet
News Market Reaction – MAJI
On the day this news was published, MAJI declined NaN%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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
ir@exousiapro.com
SOURCE: Marijuana Inc.
View the original press release on ACCESS Newswire
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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How is MAJI's preclinical trial different from typical trials?
