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, announced that the final report on Expanded Access to Trappsol® Cyclo™ for an Individual Patient with late onset Alzheimer’s disease” has been received by FDA. Cyclo Therapeutics collaborated with the Kerwin Research Center in the conduct of the expanded access program over the course of 18 months to evaluate the Company’s drug, Trappsol® Cyclo™, its proprietary formulation of hydroxypropyl beta cyclodextrin, as a potential disease modifying treatment in a single patient with dementia of the Alzheimer’s type. The drug was administered once a month by intravenous infusion.
The final report to FDA states that the drug showed a favorable safety profile as well as encouraging observations of benefit. Safety was monitored by MRIs, ECGs, laboratory safety assessments, and adverse events, all of which supported a favorable safety profile. Neurologic and cognitive features, including memory, were assessed through monthly physician examinations and standard tests, including the Mini-Mental State Examination. After 18 months, the patient showed neurologic and cognitive stability: this is a positive outcome given that persons with Alzheimer’s Disease dementia are generally expected to decline during an 18-month timeframe. Speech fluency also improved as documented by the treating physician’s report of a decrease in latency to word-finding. In addition, mood and behavioral features of the disease improved, such as less agitation, as noted by the patient, the patient’s family and the treating physician.