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 (NPC) and Alzheimer’s Disease, today announced that it has signed a Master Services Agreement with Worldwide Clinical Trials (Worldwide), a leading Contract Research Organization (CRO), to serve as CRO for the Company’s clinical programs evaluating Trappsol® Cyclo™, the Company’s proprietary hydroxypropyl beta cyclodextrin formulation, for the treatment of Niemann-Pick Disease Type C and Alzheimer’s Disease.
The Company currently supports a Phase I clinical trial for NPC in the United States, which recently completed enrollment (ClinicalTrials.gov NCT02939547); an Extension Protocol for the US study, which includes home-based infusions (NCT03893071); and a Phase I/II trial in Europe and Israel for NPC which is nearing completion of enrollment (NCT02912793). The Company will share its design of a pivotal trial in scientific advice meetings with regulators in the US and Europe in first and second quarters of 2020, respectively.
Cyclo Therapeutics is also developing a clinical program to address Alzheimer’s Disease, building on its Expanded Access program for a late onset patient (NCT03624842).
“We are very excited to take this next step in working with Worldwide, an industry leader in the rare disease and neurological disease space,” said N. Scott Fine, Company Chairman and CEO. “Worldwide will play a vital role as we build and execute our clinical programs in NPC and Alzheimer’s Disease.”
Worldwide Clinical Trials’ President and Chief Operating Officer, Peter Benton, said, “The scientific, medical and operational experts at Worldwide are privileged to be associated with Cyclo Therapeutics’ innovative clinical development program seeking to address the significant unmet clinical needs for NPC and Alzheimer’s patients.”
About Cyclo Therapeutics:
Cyclo Therapeutics, 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 in three ongoing formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease (Clinical Trials.gov NCT02939547, NCT02912793 and NCT03893071), and in 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
About Worldwide Clinical Trials:
Worldwide Clinical Trials employs more than 1,700 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs—in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services.
With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, general medicine, oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO.
For more information, visit http://www.worldwide.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.