Favorable risk/benefit analysis outlined in report to FDA
ALACHUA, FL / ACCESSWIRE / June 10, 2019 / 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 annual report on "Expanded Access to Trappsol Cyclo for an Individual Patient with Late-Onset Alzheimer's Disease" has been received by FDA according to investigator-sponsor Diana R. Kerwin, MD, President, Kerwin Research Center, allowing the company to continue to support the program. The program tests CTD's drug, Trappsol Cyclo, its proprietary formulation of hydroxypropyl beta cyclodextrin, as a potential disease modifying treatment in a single patient with dementia of the Alzheimer's type. The drug is administered once a month by intravenous injection.
CTD's Chairman and CEO N. Scott Fine said, "We are grateful to FDA for allowing CTD to provide Trappsol Cyclo to the patient, and we look forward to continuing to advance our understanding of the drug's effects in this first geriatric patient to use our drug. We expect that the results from this Expanded Access program will be critical in our design of formal clinical studies for the Alzheimer's population."
CTD collaborates with Diana R. Kerwin, MD, President, Kerwin Research Center, as the investigator-sponsor, in the conduct of this expanded access program. Over the course of the first year of the program, safety was assessed by MRIs, audiology, ECGs and standard laboratory tests. Cognitive and behavioral assessments included the Mini-Mental State Examination and standard neurologic testing (see ClinicalTrials.gov NCT03624842 for protocol details).
The one-year report describes a favorable safety profile as well as encouraging initial observations on potential benefit. "The report suggests cognitive and neurologic stability, indicating possible benefit," said Sharon Hrynkow PhD, CTD's Chief Scientific Officer and Senior Vice President for Medical Affairs. This is a positive outcome given that persons with Alzheimer's Disease dementia are generally expected to decline during a one-year timeframe. "The data to date suggest that the patient continue with monthly dosings," said Dr. Hrynkow. Biomarker data for cholesterol synthesis and metabolism and imaging are now underway.
Adverse events observed during the first year of dosings were mild in most instances and moderate in one. Mild events included diarrhea, phlebitis and blood pressure increase, all of which were found to be clinically insignificant. One moderate event was observed, a vasovagal episode: it was unclear if the event was related to the drug or to underlying medical conditions.
With the support of the treating physician, the patient and the patient's family, the second year of monthly dosing is expected to commence this month.
As part of the partnership with the Kerwin Research Center on the expanded access program, CTD holds rights to all data for the purposes of commercialization.
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.
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.
Investor/Media Contact:
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Wendy Tanaka
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SOURCE: CTD Holdings, Inc.
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