In This Article:
- 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.