CTD Holdings Announces FDA Authorization to Proceed with Single Patient IND for Use of Trappsol(R) C
Monday, March 12, 2018
CTD Holdings Announces FDA Authorization to Proceed with Single Patient IND for Use of Trappsol(R) Cyclo(TM) to Treat Alzheimer's Disease
ALACHUA, FL -- 03/12/18 -- CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, announced today that a single patient IND expanded access program using the company's proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™, for the treatment of Alzheimer's Disease has been authorized to proceed by US FDA. The IND was submitted by Diana Kerwin, MD, of the Kerwin Research Center, LLC. Dr. Kerwin is a recognized expert in Alzheimer's disease and memory disorders who was previously part of the Northwestern University, National Institute on Aging-funded, Cognitive Neurology and Alzheimer's Disease Center, where she oversaw clinical trials and clinical research for the development of treatments for Alzheimer's Disease. As part of the IND application, CTD provided Dr. Kerwin with access to its Type II Drug Master File at the FDA and provided technical input on development of the protocol. CTD will play an active role in monitoring progress of the program.
"With few treatment options available for Alzheimer's disease, there is an enormous unmet medical need for new approaches to tackle this devastating disease," said N. Scott Fine, CTD's Chairman and CEO. "When we were requested to provide Trappsol® Cyclo™ for this compassionate use program, we agreed, with the hope that it would help not only this single individual but ultimately many more who suffer from this devastating disease."
About CTD Holdings:
CTD Holdings, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need. 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 informal clinical trials. Additional indications for the active ingredient in Trappsol® Cyclo™, are in development. For additional information, visit the company's website: www.ctd-holdings.com
Safe Harbor Statement:
This press release contains "forward-looking statements" about the company's 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 company's future performance include the company's 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 company's 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 company's filings with the Securities and Exchange Commission, including, but not limited to, the company's 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.
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