Protocol Available on ClinicalTrialsgov ALACHUA Fla Aug 13 2018 GLOBE NEWSWIRE -- CTD Holdings Inc CTDH a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need announced today that the protocol for use of the companys proprietary hydroxypropyl beta cyclodextrin Trappsol R Cyclo TM in a single patient with late onset Alzheimers Disease is now publicly available on ClinicalTrialsgov NCT 03624842 The Principal Investigator for the protocol is Diana Kerwin MD President of Kerwin Research Center and a recognized expert in Alzheimers Disease and memory disorders The Kerwin Research Center is sponsoring the project with CTD Holdings as collaborating partner With this cooperative research program we will continue to advance our knowledge of how Trappsol R Cyclo TM interacts with cholesterol in patients with cholesterol-related disease This knowledge will help us as we seek to develop therapies for Alzheimers Disease and other indications said N Scott Fine CTDs Chairman and CEO Cholesterol has been linked to the formation of amyloid beta plaques one of the hallmarks of Alzheimers disease Hydroxypropyl beta cyclodextrins have been shown to clear cholesterol from cells to stabilize cholesterol metabolism and to reduce the formation of amyloid beta plaques in animal models CTD currently supports two clinical trials NCT02939547 and NCT02912793 using Trappsol R Cyclo TM intravenously in patients with Niemann-Pick Disease Type C NPC a rare and fatal disease in which cholesterol accumulates in every cell in the body NPC has also been called Childhood Alzheimers due to the cognitive decline which is apparent in many NPC patients I am pleased to be working with CTD on this program and to build on the platform of safety data and knowledge within the company on cyclodextrins and their potential to address cholesterol-related diseases With millions suffering from Alzheimers Disease in the United States alone this collaboration is very timely said Dr Kerwin The protocol describes an initial dosing regimen of 500 mg kg given intravenously with monthly increases in dose provided that safety and tolerability features are positive We will examine a number of factors to assess the risk-benefit ratio including brain imaging adverse events changes in blood biomarkers and pharmacokinetic data said Sharon Hrynkow PhD CTDs Senior Vice President for Medical Affairs What we learn will be important not only to the single patient involved in this current project but also potentially for all of CTDs clinical studies including our priority trials on Niemann-Pick Disease Type C About CTD Holdings CTD Holdings Inc is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease The companys Trappsol R Cyclo TM 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 two ongoing formal clinical trials Clinical Trialsgov NCT02939547 and NCT02912793 Additional indications for the active ingredient in Trappsol R Cyclo TM are in development For additional information visit the companys website wwwctd-holdingscom Safe Harbor Statement This press release contains forward-looking statements about the companys current expectations about future results performance prospects and opportunities Statements that are not historical facts such as anticipates believes and expects or similar expressions are forward-looking statements These statements are subject to a number of risks uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in or implied by these statements The factors which may influence the companys future performance include the companys ability to obtain additional capital to expand operations as planned success in achieving regulatory approval for clinical protocols enrollment of adequate numbers of patients in clinical trials unforeseen difficulties in showing efficacy of the companys biopharmaceutical products success in attracting additional customers and profitable contracts and regulatory risks associated with producing pharmaceutical grade and food products These and other risk factors are described from time to time in the companys filings with the Securities and Exchange Commission including but not limited to the companys reports on Forms 10-K and 10-Q Unless required by law the company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events