Expanded Access to Investigational Medicines
Cyclo Therapeutics, Inc. is a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from disease. Our current focus is on the development of a cyclodextrin-based product for the potential treatment of Niemann-Pick Disease Type C, a rare and fatal genetic disease, and for Alzheimer’s Disease. The Company’s proprietary formulation of cyclodextrin, Trappsol® Cyclo™, an Orphan Drug Designated product in the United States and Europe, is the subject of four formal clinical trials for Niemann-Pick Disease Type C (ClinicalTrials.gov NCT02939547, NCT02912793, NCT03893071 and NCT04860960), all of which are based on intravenous (IV) administration of the drug. The Company is also planning an early-phase clinical trial using Trappsol® Cyclo™ intravenously in Alzheimer’s Disease based on encouraging data from a physician-led Expanded Access IND for late-onset Alzheimer’s Disease (ClinicalTrials.gov NCT03624842).
Cyclo Therapeutics has provided Trappsol® Cyclo ™ to physicians for their use in single patient expanded access programs. At this time, Cyclo Therapeutics does not intend to provide access to new physician-led expanded access programs. We encourage patients to participate in clinical trials of our investigational therapies whenever possible, because clinical trials are designed, conducted, and monitored to ensure that the safety and efficacy of investigational therapies are appropriately evaluated before they are submitted to regulatory agencies for review with the intent to make them more broadly available to patients. Cyclo Therapeutics reserves the right to revise this Expanded Access Policy at any time.
You and your health care provider may learn more about our clinical trials by going to the pipeline section of our website, or by visiting www.clinicaltrials.gov and searching for “Cyclo Therapeutics” or by sending a request for information to firstname.lastname@example.org. The Company aims to acknowledge requests for information within 5 business days of receipt.
Trappsol® Cyclo™ is not currently approved for any indication.
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