Expanded Access Policy

Expanded Access Policy (EAP) statement – Medeor Therapeutics

Medeor Therapeutics is a pharmaceutical research enterprise focused on the development of cell therapy interventions in transplant patients for the purposes of reducing immunosuppressive therapy and reducing the occurrence of organ rejection and graft-vs-host disease. Our mission is to create individualized cell therapy preparations for these serious conditions, which involve highly complex and resource intensive processes.

Medeor is conducting human clinical trials to demonstrate that its investigational agents are safe and effective, with data from these trials to be used in support of a marketing application to the U. S. Food and Drug Administration (FDA) and other regulatory authorities.

We understand that patients may seek access to investigational agents prior to review and approval by regulatory bodies such as FDA, which may be possible through participation in clinical trials or under expanded access (as defined below). It is our intent to encourage patients to participate in clinical trials whenever possible, in order to complete studies required by regulatory bodies to evaluate the safety and effectiveness of the agent under investigation. For more information on Medeor’s clinical trials that may be recruiting new patients, please search Medeor on www.clinicaltrials.gov. We encourage patients to speak first with their physician about their eligibility to enroll in a clinical trial before requesting Expanded Access, as well as to discuss the benefits and risks of any such option considered. Under exceptional circumstances, when patients do not qualify for clinical trials and are without other treatment options, Expanded Access (EA) may be considered.

Expanded Access, (sometimes termed as compassionate use, early access or emergency use) refers to the use of an investigational agent outside of a clinical trial, with the primary purpose of treating a serious or immediately life-threatening disease or condition in a patient. Expanded Access is different from clinical trials in which more comprehensive information about safety and effectiveness are required to be collected in clinical trials.

At this time, Medeor is not offering Expanded Access. Medeor’s investigational products must be limited to existing clinical research partners for many reasons, including the current requirement of individualized cell therapy preparations and related capacity limitations. Further access could potentially delay development commitments to complete clinical trials that, if such products are approved, would ultimately make our products available to many more patients. In accordance with the regulatory status of investigational agents, those materials are not available for purchase.

Contact information: To request additional information on expanded access to any of Medeor’s cell-based therapies, please email contactEA@medeortx.com. As stated earlier, Medeor is currently not providing Expanded Access to its investigational products. However, any request for Expanded Access needs to be made by a patient’s primary physician, and a response will be provided within 7 calendar days. If the request is approved by Medeor, the regulatory authority from the country in which the request was made will need to grant final approval for its use. Additional information is available from the FDA at https://www.fda.gov/news-events/public-health-focus/expanded-access