Exousia Pro Finishes Preclinical Trial for Glioblastoma Ahead of Schedule - Bolstering Orphan Drug Application

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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

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- 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 90% of glioblastoma preclinical studies rely on genetically engineered or chemically induced mouse models, limiting their relevance to human disease. Exousia Pro set a higher standard by employing a sophisticated humanized mouse model. By implanting surgically removed human glioblastoma tumor cells into immunodeficient mice, we ensured a clinically relevant evaluation of therapeutic efficacy. This approach significantly enhances the credibility of our results. While more costly, this rigorous approach ensures robust, translatable results, as the therapy's efficacy is tested without interference from the mouse's immune system.

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
ir@exousiapro.com

SOURCE: Marijuana Inc.

View the original press release on ACCESS Newswire

FAQ

What results did Exousia Pro (MAJI) achieve in its 2025 glioblastoma preclinical trial?

Exousia Pro completed its glioblastoma preclinical trial ahead of schedule using 32 humanized mice divided into four treatment groups. The trial tested tumor response to control, temozolomide alone, exosome treatment alone, and a combined therapy. Final results are expected by mid-to-late May 2025.

How does Exousia Pro's (MAJI) exosome therapy work against glioblastoma brain cancer?

Exousia Pro's exosome therapy uses a unique process where cells target and load exosomes in a single step. When combined with minimal chemotherapy, their in vitro studies showed enhanced elimination of cancer stem cells, which are the main obstacle in treating glioblastoma effectively.

What makes Exousia Pro's (MAJI) glioblastoma trial different from other preclinical studies?

Unlike 90% of glioblastoma studies that use genetically engineered mice, Exousia Pro used a sophisticated humanized mouse model with actual human glioblastoma tumor cells implanted into immunodeficient mice, providing more clinically relevant results.

When will Exousia Pro (MAJI) submit its FDA Orphan Drug Application for glioblastoma treatment?

Following the completion of preclinical trials in April 2025, Exousia Pro plans to submit key positive preclinical data to the FDA to advance their Orphan Drug Application, though no specific submission date was announced.

What potential benefits could Exousia Pro's (MAJI) glioblastoma treatment bring to patients?

The treatment could transform glioblastoma care by offering a more effective therapy that combines exosomes with minimal chemotherapy to target cancer stem cells, potentially providing a new standard of care for this aggressive brain cancer.