GAINESVILLE, Fla.--(BUSINESS WIRE)-- Cyclo Therapeutics, Inc. (OTCQB: CTDH), a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C and Alzheimer’s Disease, today announced that it has completed patient enrollment in its Extension Protocol to the Phase I trial to evaluate the safety and tolerability of Trappsol® Cyclo™ administered intravenously to Niemann-Pick Disease Type C1 (NPC1) patients.
“Today’s announcement is another critical milestone for our company and the NPC community,” said Company Chairman and CEO, N. Scott Fine. “All eligible patients who completed the Phase I trial entered the Extension Protocol, an important signal of how patients perceive benefits of receiving Trappsol® Cyclo™ intravenously.”
Niemann-Pick Disease Type C is a rare genetic disease affecting 1 in 100,000 live births globally. NPC affects every cell in the body due to a defect in the NPC1 protein which is responsible for cholesterol processing in the cell. NPC causes symptoms in the brain, liver, spleen, lung and other organs and often leads to premature death. There are no approved drug therapies for NPC in the United States and only one approved therapy in Europe.
“The Extension Protocol allows subjects who are resident in the United States to continue receiving our drug through home-based infusions, with qualified healthcare personnel oversight,” said Sharon Hrynkow PhD, Cyclo Therapeutics’ Chief Scientific Officer and Senior Vice President for Medical Affairs. ”All foreign patients who participated in the trial also wish to continue on the drug: some are well underway in approved expanded access use programs, and others are now in process.”
Data from the current study combined with those of the companion Phase I study (ClinicalTrials.gov NCT02939547) and the Phase I/II trial underway in Europe and Israel (ClinicalTrials.gov NCT02912793) will be used to inform the design of the Company’s global pivotal trial. Cyclo Therapeutics, Inc. will meet with FDA in the first quarter of 2020 and expects to meet with EMA in the second quarter of 2020 to discuss the global pivotal development plan and timelines to initiate the pivotal trial.
About Cyclo Therapeutics:
Cyclo Therapeutics, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C and Alzheimer’s Disease. The company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is the subject of three ongoing formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, (ClinicalTrials.gov NCT02939547, NCT02912793 and NCT03893071). The company is planning an early phase clinical trial using Trappsol® Cyclo™ intravenously in Alzheimer’s Disease based on encouraging data from an Expanded Access program for late-onset Alzheimer’s Disease (NCT03624842). Additional indications for the active ingredient in Trappsol® Cyclo™ are in development. For additional information, visit the company’s website: www.cyclotherapeutics.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: Cyclo Therapeutics, Inc.