01. Enlivex Policy for Evaluating Access to Investigational Agents Outside of Clinical Trials
Enlivex, currently is testing in clinical trials investigational drugs that have not yet been approved by the US Food and Drug Administration (FDA) or other regulatory bodies for commercial sale. We have conducted and are conducting research on our investigational product pipeline so that we can better understand how these investigational therapies work and their safety and efficacy. Patients with serious diseases or conditions often exhaust standard treatment options and seek out investigational therapies being tested in clinical trials. Sometimes these investigational therapies may be available to them as part of a clinical trial. People who take part in clinical trials help society by contributing to medical research, the development of new therapies, and the advancement of patient care. When patients are not able to participate in a clinical trial, treating physicians can request drug companies like Enlivex to make these investigational therapies available to their patients outside of clinical trials. Enlivex is committed to helping patients who have failed available therapies and may benefit from treatment access to the investigational therapies that we are developing in a manner that is both scientifically and ethically responsible. This Policy for Access to Investigational Agents describes the principles, criteria and government regulations that we will follow when considering a request from physicians for patients outside of our clinical trials. This covers requests from a treating physician for investigational therapy for an individual patient, not requests for investigator-initiated trials.
- The investigational therapy must be in active clinical development. Enlivex must be actively studying the investigational therapy in human subjects. Restricting access to investigational therapies with active clinical programs also ensures that there are Enlivex personnel who are trained and responsible for the safe release of the investigational therapy.
- The patient must be first considered for ongoing clinical trials of the investigational therapy. Treating physicians interested in treating their patient with Enlivex investigational therapies in active clinical development must first try to enroll their patients in a clinical trial studying the investigational therapy. Clinical trials incorporate regular safety monitoring, and create a venue for investigator training on the potential risks of the investigational therapy.
- The patient must have a serious disease or condition. Serious is defined in this document as a disease or condition associated with morbidity that has a substantial impact on day-to-day functioning.
- There must be a positive benefit-risk ratio for the patient. The potential benefits to the patient seeking access to the investigational therapy must always outweigh the collective potential risks to the patient of offering the investigational therapy.
- The physician requesting access must provide:
* An explanation of the serious nature of the illness
* A scientifically justified rationale for the theoretical benefit that the investigational therapy could provide
* A statement that approved therapies typically used to treat the disease have been exhausted and the patient is no longer responsive to, or able to tolerate, these therapies
* A statement that there are no other viable therapy options, including participation in ongoing relevant clinical trials.
- After meeting the needs of clinical trials and other existing patients on therapy, Enlivex must have, and believe it will continue to have throughout the likely duration of treatment, a sufficient supply of the investigational therapy to reasonably accommodate the likely duration of treatment.
02. Contact for Further Information
Persons with questions about Enlivex’ policy and procedures for expanded access or about expanded access to Enlivex investigational drugs may send an email to the following address: firstname.lastname@example.org