AffyImmune is committed to developing next-generation T cell therapies for cancer patients who have serious and life-threatening diseases or conditions.
Our Expanded Access Policy (EAP) refers to the use of an investigational cell therapy outside of a clinical trial. Sometimes called “compassionate use”, expanded access is a potential pathway for a patient to gain access to investigational therapies in certain rare circumstances in which a person has no other available therapies or is not eligible to participate in a current AffyImmune clinical trial. At AffyImmune, we recognize and understand the need for an expanded access policy for patients who have serious or immediately life-threatening disease and have limited available treatment options.
The decision to establish an EAP is dependent on several key factors consistent with the US Food and Drug Administration (FDA) and other regulatory agencies’ guidelines. These include, but are not limited, to the following:
- The patient or patients to be treated have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;
- The potential patient benefit justifies the potential risks of using the treatment and those potential risks are not unreasonable in the context of the disease or condition to be treated; and
- Providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.
AffyImmune believes that participation in one of our clinical trials is the best way to access our investigational cell-based gene therapies. We encourage patients to speak with their physicians regarding participating in clinical trials. In rare cases where patients with serious diseases are unable to participate in clinical trials and have exhausted all available options, AffyImmune may consider providing our investigational therapies outside of a clinical trial. As a general policy, AffyImmune will not provide our investigational therapies until sufficient preliminary safety and efficacy information has been obtained in our clinical trials, typically following Phase 2 investigation.
If you are a patient who is interested in accessing our investigational cell therapies, please speak with your physician. You may also learn more about ongoing clinical trial(s) by going to www.clinicaltrials.gov and searching for AffyImmune.
If you are a physician who is interested in learning more about our investigational cell therapies, or participating in our clinical trials, please submit a request to clinicaltrials@AffyImmune.com. We will use our best efforts to respond within 3 business days after receipt of your request.