Cyclo Therapuetics (OTCQB: CTDH), formerly CTD Holdings, a biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, announced the completion of patient enrollment in its Phase I trial to evaluate the safety and tolerability of Trappsol® Cyclo™ administered intravenously to Niemann-Pick Disease Type C (NPC) patients.

Why It Matters: It is anticipated that data from the last patient enrolled in the study will be available in February 2020. Cyclo Therapeutics Inc. will then unblind the study results and analyze the data. Data from the current study combined with those of the companion Phase I/II study, nearing completion of enrollment in EU-Israel, are expected to be used in the company’s market registration applications.

Key Quote: “Today’s ‘Last-Patient-In’ announcement is a significant milestone for our company and the NPC community. It completes another important step in our development and registration strategies for Trappsol® Cyclo™ to treat NPC, a disease which causes much suffering for the patients and their families. We are delighted to share this news with our many supporters and all of our stakeholders.” – N. Scott Fine, Chairman & CEO

The Backstory: Complete enrollment in the study required 12 patients, all of whom were enrolled at one site in the United States, UCSF Benioff Children’s Hospital Oakland, CA with Co-Principal Investigators Caroline Hastings, MD and Benny Liu, MD. The study is a randomized, double-blind study using Trappsol® Cyclo™ intravenously in NPC patients age 18 years and older. Study subjects receive 7 doses of the drug at either 1500 mg/kg or 2500 mg/kg and are assessed for adverse events, markers for cholesterol metabolism following drug administration, and symptomatic changes using an NPC severity scoring tool, among other tests. The company has reported initial data from this study that suggests a favorable safety profile; a temporal link between administration of the drug and clearance of cholesterol from cells; presence of the drug in the cerebrospinal fluid following IV administration; and reduction in a neuron-specific biomarker, tau, that is associated with neuronal degeneration in NPC patients.

Disclosure

Cyclo Therapeutics (OTCQB: CTDH) is a client of RedChip Companies. CTDH pays RedChip a monthly cash fee of between $15,000 and $30,000 for investor awareness services.