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Classified in: Health, Science and technology
Subject: Conference

Cyclo Therapeutics to Present at 2020 Annual Conference for NPC Patients, Families, and Health Professionals in the United Kingdom


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 the company will present on its clinical and drug development program for the orphan drug, Trappsol® Cyclotm, at the Niemann-Pick UK (NPUK) 11th Interactive Workshop on Niemann-Pick Diseases and the 27th Annual NPUK Family Conference. The conference brings together patients, families, caregivers, scientists, and health professionals for the purposes of learning about advances in NPC clinical trials and providing opportunities for community learning, sharing and support. The conference will take place virtually from September 25 to 27, 2020.

As it has for the past 5 years, Cyclo Therapeutics also provided an unrestricted grant to the NPUK to assist in support of all conference related activities.

Niemann-Pick Disease Type C (NPC) is a rare and fatal genetic disease affecting 1 in 100,000 live births globally. NPC affects every cell in the body due to the defect in the NPC protein which is responsible for cholesterol processing in the cell. Because of the NPC protein defect in this disease, cholesterol accumulates abnormally in every cell in the body, causing symptoms in the brain, liver, spleen, lung and other organs.

Cyclo Therapeutics' presentations at the conference will include data from its completed Phase I safety and tolerability trial based in the United States utilizing intravenous administration of Trappsol® Cyclotm, its proprietary formulation of hydroxypropyl beta cyclodextrin, for the treatment of NPC (NCT02939547) and from its fully enrolled Phase I/II safety and efficacy trial based in the UK, Sweden, and Israel using the same drug and also with intravenous administration (NCT02912793). An extension trial for the Phase I US-based trial is underway (NCT03893071): the extension trial allows for home-based infusions by skilled health care professionals.

On the first day of the conference, a presentation to scientists and health professionals on the company's Clinical Trials for NPC will be made by N. Scott Fine, Cyclo Therapeutic's Chairman and CEO and Sharon H. Hrynkow, PhD, Cyclo Therapeutic's Chief Scientific Officer and Senior Vice President for Medical Affairs. On the second day of the conference, a similar presentation will be made to NPC patients, families and caregivers by Caroline Hastings, MD, Clinical Director, NeuroOncology Program, Children's Hospital and Research Center Oakland, CA (for the Phase I trial) and Reena Sharma, MD, Consultant in Inherited Adult Inherited Metabolic Disorders, Mark Holland Metabolic Unit, Salford Royal Hospital NHS Foundation Trust, Salford, UK (for the Phase II trial). Dr. Hastings is Principal Investigator for the US Phase I trial and Dr. Sharma is Principal Investigator for the Phase I/II trial at the Salford site and also the EU Coordinating Investigator.

Presentation Details:

NPUK 11th Interactive Workshop on Niemann-Pick Diseases (participants are health professionals and scientists)

Date: Friday, September 25th

"Update on Cyclo Therapeutic's Clinical Trials for NPC"
Dr. Sharon Hrynkow.

NPUK 26th Annual Family Conference (participants are NPC patients and families, with updates on clinical trials provided by health professionals)

Date: Saturday, September 26th

"Update on Cyclo Therapeutics' Phase I and Phase I/II trials for NPC"
Dr. Sharon Hrynkow
Dr. Caroline Hastings
Dr. Reema Sharma.

About Cyclo Therapeutics:

Cyclo Therapeutics, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C and Alzheimer's Disease. The company's Trappsol® Cyclotm, an orphan drug designated product in the United States and Europe, is the subject of three ongoing formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, (ClinicalTrials.gov NCT02939547, NCT02912793 and NCT03893071). The company is planning an early phase clinical trial using Trappsol® Cyclotm intravenously in Alzheimer's Disease based on encouraging data from an Expanded Access program for late-onset Alzheimer's Disease (NCT03624842). Additional indications for the active ingredient in Trappsol® Cyclotm are in development. For additional information, visit the company's website: www.cyclotherapeutics.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.


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