Date: 03-Jan-2020

Cyclo Therapeutics Signs Master Services Agreement with Worldwide Clinical Trials

Cyclo Therapeutics, Inc., 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.”