Compassionate Use and Expanded Access Requests
Matrix Biomed, Inc. strives to make lives better through advanced science and better drugs. Our mission is to develop gene-based therapeutics that transform the lives of those affected by a number of diseases. With our transformative drugs having the potential to impact so many people with so many diseases, there may be diseases and treatment groups that we have not yet been able to reach through clinical trials.
However, before our drugs become available through traditional means, we are committed to reviewing compassionate use requests and providing our drugs to candidates who meet appropriate qualifications and who could benefit immensely from the treatment.
In the cases where one of our clinical trials is not an option and the patient has a life-threatening or severely debilitating disease, regulators may grant permission for the patient to use one of our unapproved drugs. This use of an unapproved investigational drug is often called “compassionate use” or “expanded access.”
Matrix Biomed, Inc. will consider compassionate use of one of our investigational drugs if all of the following are met:
- The patient has a life-threatening or severely debilitating disease with no comparable or satisfactory alternative therapies;
- The patient is ineligible for, or otherwise unable to, participate in a clinical trial;
- The patient has a disease for which there is sufficient evidence to project a benefit from the use of the investigational drug ;
- The investigational drug is currently in clinical development and being tested on humans; and
- Providing the investigational drug under compassionate use does not interfere with the initiation, conduct, or completion of clinical trials.
For all compassionate use requests, please submit your request and all documentation to firstname.lastname@example.org. Matrix study staff will review your request as soon as possible and have an initial reply within 14 days. Each request will receive a thorough review; however, not all Compassionate Use requests may be granted.