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To serve patients, Celimmune engages in clinical research to evaluate investigational new treatments with the goal of obtaining regulatory approval for products that demonstrate adequate safety and efficacy. This Policy for Requests for Expanded Access to Unapproved Drugs describes the principles and procedures that Celimmune will follow when considering requests by physicians for use of unapproved drugs for serious diseases or conditions outside of Celimmune’s clinical trials.
Celimmune’s lead investigational product, AMG714, is currently being investigated for the following serious disease: treatment of Refractory Celiac Disease Type II (RCD-II), an in situ intestinal lymphoma. Information about Celimmune’s AMG714 clinical trials in RCD-II can be found on the NIH’s ClinicalTrials.gov website: AMG714 RCD-II.
Under very exceptional circumstances, and in accordance with applicable law, Celimmune may consider, on a case-by-case basis, providing continued access to RCD-II patients, who have participated in AMG714 clinical research, once a clinical trial has been completed. All requests must be made by a physician. The physician requesting access to the Celimmune unapproved drug must: 1) be licensed and qualified to prescribe the investigational drug; 2) agree to directly supervise the treatment; 3) be willing to obtain an Investigational New Drug Application (IND) from the United States Food and Drug Administration (FDA) or corresponding international regulatory authority, or otherwise comply with relevant US federal and state or relevant international laws and regulations; 4) agree to follow and abide by any and all Celimmune policies generally applicable to expanded access and any other conditions or restrictions set by Celimmune for the requested drug and particular patient.
Specifically, Celimmune may provide physician-requested and physician-led expanded access to AMG714 for RCD-II patients with serious or immediately life-threatening disease or condition who lack other therapeutic options; are no longer eligible to join an actively enrolling AMG714 clinical trial; and where the potential benefits of AMG714 are assessed to be greater than the known risks of RCD-II, given the specific patient’s medical condition. Further, after meeting the needs of its clinical trials and other patients, Celimmune must make a determination that it has sufficient supply of the unapproved drug to reasonably accommodate the likely duration of treatment. The decision to grant access is solely Celimmune’s decision. There is no guarantee that AMG714 expanded access will be provided for any specific patient. As a condition to receiving the unapproved drug, the requesting physician and patient to whom the drug will be administered pursuant to this Policy must agree to waive any and all claims against Celimmune, its officers and affiliated companies or entities for any damages that arise from or are related to the treatment of the patient with the investigational drug.
Physicians who participated in Celimmune’s AMG714 RCD-II trials have been informed of the process by which requests for expanded access can be made. Other persons with questions about this program, or about Celimmune’s policies and procedures for expanded access, or who may wish to request expanded access, may contact the Company at the following email address: email@example.com. Receipt of emails will be acknowledged within two weeks.