ALACHUA, Fla.–(BUSINESS WIRE)–CTD Holdings, Inc. (OTCQB: CTDH), a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, today announced that the Company had obtained a Right of Reference letter to IND 138423. The IND is for “Expanded Access to Trappsol® Cyclo™ for an Individual Patient with Late-Onset Alzheimer’s Disease,” with Investigator-Sponsor Diana R. Kerwin MD, President of the Kerwin Research Center.
CTD’s proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™, is the drug product used in the expanded access protocol. The Right of Reference letter gives CTD access to any and all data from the expanded access protocol to develop and commercialize Trappsol® Cyclo™ for the Alzheimer’s Disease indication.
CTD Chairman and CEO N. Scott Fine said, “Our collaboration with the Kerwin Research Center is yielding important data on safety of the drug in a geriatric patient as well as information on how our drug may impact Alzheimer’s disease progression. The Right of Reference provides CTD with access to data generated from the expanded access protocol, allowing us to continue to work concretely to identify partners to advance the development of Trappsol® Cyclo™ for the Alzheimer’s indication.”
As reported recently, the IND annual report on “Expanded Access to Trappsol® Cyclo™ for an Individual Patient with Late-Onset Alzheimer’s Disease” was received by FDA in May, according to Dr. Kerwin, allowing CTD to continue to support the program into a second year. Trappsol® Cyclo™ is administered once a month by intravenous injection in this protocol (see ClinicalTrials.gov NCT03624842).
Sharon Hrynkow PhD, CTD’s Chief Scientific Officer and Senior Vice President for Medical Affairs said, “Alzheimer’s Disease or dementia affects 5 million Americans, and the numbers are growing. We look forward to continuing on our development pathway for Trappsol® Cyclo™ as a therapeutic for this insidious disease.”
About CTD Holdings:
CTD Holdings, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease. The company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is used to treat Niemann-Pick Disease Type C, a rare and fatal genetic disease, on a compassionate use basis as well as in three ongoing formal clinical trials (Clinical Trials.gov NCT02939547, NCT02912793 and NCT03893071). Additional indications for the active ingredient in Trappsol® Cyclo™ are in development. For additional information, visit the company’s website: www.ctd-holdings.com
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