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ALACHUA, FL / ACCESSWIRE / May 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 one patient who completed CTD's Phase I/II clinical trial using the company's proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™, will continue to have access to the drug through an approved expanded access program. Approval was granted by the Medicines and Healthcare Products Regulatory Agency. The trial completed by the patient is "A Phase I/II Study to Evaluate the Safety and pK of Intravenous Trappsol® Cyclo™ in Patients with Niemann-Pick Disease Type C (NPC1) and Pharmacodynamic Effects of Treatment Upon Markers of Cholesterol Metabolism and Clinical Outcomes" (ClinicalTrials.gov NCT02912793).
CTD's Chairman and CEO N. Scott Fine said, "We are pleased to provide continued access to Trappsol® Cyclo™ to this patient. We are grateful to the patient and the family, as well as to the treating physician and team, for participation and support of this clinical trial."
The patient will receive the Trappsol® Cyclo™ intravenously via the Expanded Access program until the Extension Protocol for the Phase I/II trial is fully in place.
Dr. Reena Sharma, Coordinating Investigator for CTD's Phase I/II clinical trial in Europe and Israel and Principal Investigator for CTD's clinical trial site at Salford Royal Foundation Trust Hospital said, "The Expanded Access program will provide an important bridge for the patient until the Extension Protocol is in place. Since the patient has elected to remain on the drug following completion of the 48-week treatment period in the formal clinical trial, this program offers us the opportunity to continue to monitor safety and progress until the formal Extension Protocol is in place."
NPC is a rare and fatal genetic disease characterized by the accumulation of cholesterol in cells and tissues. CTD Holdings supports three clinical trials using Trappsol® Cyclo™ intravenously in Niemann-Pick disease type C: the Phase I/II described here, a companion Phase I trial in the US (NCT02939547) and an Extension Protocol in the US for the Phase I US trial (NCT03893071). CTD reported at two clinical and scientific conferences earlier this year on initial data from CTD's Phase I and Phase I/II trials: Trappsol® Cyclo™ has a positive safety profile; intravenous administration of the drug leads to cholesterol release from cells; Trappsol® Cyclo™ crosses the blood-brain-barrier; and initial efficacy data are encouraging. Physicians and scientists interested in learning more about CTD's trials should contact Sharon Hrynkow PhD, CTD's Chief Scientific Officer and Senior VP for Medical Affairs at Sharon.Hrynkow@cyclodex.com.
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.
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SOURCE: CTD Holdings, Inc.
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