Zogenix Inc
5959 Horton Street
5th Floor
Emeryville, California
United States of America
Compounds:
Expanded Access
Modis Therapeutics is committed to developing MT1621 for patients with thymidine kinase 2 deficiency (TK2d). Well designed clinical trials are the best way to determine the safety and efficacy of an investigational therapy. Clinical trial recruitment is essential in completing these clinical trials for the approval of a drug from regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). When a Modis investigational medicine is in clinical development, we encourage patients to speak with their treating physician regarding their eligibility to enroll in our clinical trials.</p.
We acknowledge there are patients with TK2d who do not qualify for enrollment in a currently active clinical trial, but their treating physician feels he/she may benefit from access to MT1621. Therefore, Modis will evaluate, on a case-by-case basis, all requests for access to MT1621. The requesting physician will be required to provide adequate medical history, including treatments, for the specific patient, by completing the intake form. Making a request does not guarantee the granting of access to MT1621. We aim to respond to all requests with appropriate urgency. In general, a written response will be provided to the requesting physician within 14 days of receipt of all medical documentation required to assess patient eligibility.
You can find more information on Modis clinical trials at ClinicalTrials.gov or about TK2d on TK2d.com. We will update the TK2d community with new information about TK2d and Modis Therapeutics clinical trials. Registration on TK2d.com is available to patients, families and physicians.