Cyclo Therapeutics has signed an agreement with Worldwide Clinical Trials, a Contract Research Organization (CRO), to conduct a clinical trial to evaluate safety and efficacy in Alzheimer’s Disease. The trial will evaluate Trappsol® Cyclo™ given by intravenous infusion. The Company has previously reported encouraging data on safety and efficacy of the product based on an FDA-approved expanded access program in a single patient with late-onset Alzheimer’s Disease.
Alzheimer’s Disease affects 5.7 million Americans. While a few symptomatic treatments are available, there are no approved disease modifying treatments.
“We are very excited to work with Worldwide, an industry leader, on this critical clinical program,” said N. Scott Fine, Company Chairman and CEO. “Our work to advance an innovative approach to treat this devastating disease may lead to improvements in the lives of Alzheimer’s patients and their families. We are pleased to have Worldwide’s team of experts working closely with us as we begin our development pathway.”
“The scientific, medical and operational experts at Worldwide offer nearly 40 years of hard-won insight gleaned from our experience on the front lines of Alzheimer’s Disease research. The journey toward halting progression of this devastating neurodegenerative disorder takes tenacity, and we’re not about to give up now,” said Henry Riordan, executive vice president, Scientific Solutions, for Worldwide. “We are thrilled to be selected by the innovators at Cyclo Therapeutics as their partner in the development of this exciting new treatment approach.”
Cyclo Therapeutics and Worldwide are designing the trial protocol and expect to schedule a scientific advice meeting with the U.S. FDA in early 2020. Patient enrollment is expected to begin shortly thereafter.