Expanded access · Compassionate use
Expanding Access to Life-Saving Cancer Therapies
Exousia Bio is developing a framework for evaluating physician-initiated requests for compassionate use of its investigational oncology technologies, initially focused on malignant glioma, including Glioblastoma Multiforme.
compassionateuse@exousiabio.com
Our glioblastoma program
Glioblastoma is an aggressive malignant tumor of the central nervous system for which significant unmet medical need remains.
Exousia Bio is developing an investigational exosome-based therapeutic platform designed to use exosomes as targeted biological delivery vehicles for selected therapeutic cargo, including nucleic-acid-based material.
The Company’s approach to GBM is being investigated in combination with established anticancer therapies, with the objective of improving delivery and effectiveness against malignant cells — including the cancer stem cells believed to play an important role in tumor recurrence.
What is compassionate use?
Compassionate Use, formally known in the United States as Expanded Access, is an FDA-regulated pathway through which certain patients with serious or immediately life-threatening diseases may receive an investigational product outside of a clinical trial
- The patient has a serious or immediately life-threatening condition.
- There is no comparable or satisfactory approved treatment available.
- The patient is unable to participate in an appropriate clinical trial.
- The treating physician believes potential benefit may justify the risks.
- Providing the therapy will not interfere with its clinical development.
- All FDA, IRB, and regulatory requirements are satisfied.
Meeting these criteria does not guarantee access to an investigational therapy.
How a request begins
01
Speak with the treating physician
Patients and families should first discuss Expanded Access with the treating oncologist or neuro-oncologist, who evaluates diagnosis, treatment history, available therapies and trials, and investigational risk.
02
Physician contacts Exousia Bio
If Expanded Access may be medically appropriate, the physician may contact the Company on the patient’s behalf with sufficient medical information for review.
03
Medical and scientific review
Each request is reviewed individually against diagnosis and disease status, prior treatments, remaining alternatives, trial availability, eligibility, risk-benefit, product availability, manufacturing capacity, and regulatory requirements.
04
Regulatory authorization
May include an Individual Patient Expanded Access request to the FDA, IRB review, informed consent, treatment protocols, safety monitoring, and reporting. Authorization must be obtained before treatment begins.
Important information for patients and families
Exousia Bio is committed to reviewing legitimate physician requests carefully, responsibly, and as promptly as practicable. However, investigational therapies involve significant uncertainty. The Company’s investigational cancer therapies.
- Have not been approved by the FDA for commercial use.
- Have not been established as safe or effective for GBM or any other cancer.
- May not provide clinical benefit.
- May cause known or unknown side effects, including serious adverse events.
- May not be appropriate for every patient, or available in sufficient quantities.
Whenever possible, participation in an appropriately designed clinical trial remains the preferred route to an investigational therapy.
For physicians
Inquiries regarding the investigational GBM program should include:
Patient-identifying medical information should only be transmitted using a secure method authorized by Exousia Bio.