International Niemann–Pick Disease Alliance
Conference Brings Together Medical Researchers and Health Professionals to Exchange Information on Lysosomal Diseases
Gainesville, FL – (Businesswire) – 19 November 2020 Cyclo Therapeutics, Inc. (OTCQB: CTDH), a clinical stage biotechnology company developing a cyclodextrin platform for the treatment of Neurodegenerative Diseases, including their lead candidate (Trappsol® Cyclo™) in the treatment of Niemann-Pick Disease Type C (NPC) today announced that the company will present on its clinical and drug development program for the orphan drug, Trappsol® Cyclo™, at the 17th Annual WORLDSympsium 2021, a leading medical and scientific conference for professionals working to advance understanding and treatments for lysosomal storage diseases, including NPC. Cyclo Therapeutics’ proposals to present at the conference were accepted after scientific and medical review. The conference will be held virtually between February 8–12, 2021.
Cyclo Therapeutics will make both a platform presentation (pre-taped with opportunity for live Q and A with the audience) and a poster presentation (with availability for discussion at a prescribed time) with data from two clinical trials. Exact timing for each presentation has not yet been determined by the organizers. Updates on timing of each presentation will be posted to the Cyclo Therapeutics website.
Caroline Hastings, MD, UCSF Benioff Children’s Hospital Oakland, California, Principal Investigator, will present data on safety and mechanism of action from the completed Phase I clinical trial using the company’s proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™, administered intravenously, in patients 18 years and older. Dr. Hastings, a member of the Company’s Scientific Advisory Board, is also the first physician in the United States to use this class of drug and specifically Cyclo Therapeutics’ product on a compassionate use basis in NPC patients. Her work paved the way for the present drug development program at Cyclo Therapeutics in NPC.
Julian Raiman, MD, Birmingham Women’s and Children’s Hospital, United Kingdom, Principal Investigator, will present interim data on safety and efficacy from the Phase I/II trial underway in the UK, Sweden and Israel using Trappsol® Cyclo™ in NPC patients aged 2 and older.
Sharon Hrynkow, PhD, the company’s Scientific Officer and Senior Vice President for Medical Affairs, is a co-author of both presentations.
Poster presentation: “Update on Phase I study to evaluate the single- and multiple-dose pharmacokinetics of intravenous Trappsol® Cyclo™ (HPβCD) in patients with Niemann-Pick disease type C (NPC-1) and the effects of dosing upon biomarkers of NPC disease. Caroline Hastings, MD; Benny Liu, MD (Alameda Health System and UCSF Benioff Children’s Hospital), Alan Boyd, MD (Boyd Consultants, UK) and Sharon Hrynkow PhD.
Platform presentation and Poster presentation: Update on Safety and Efficacy Results for Phase I/II trial of Hydroxypropyl Beta cyclodextrin (HPβCD) Administered Intravenously in Patients with Niemann-Pick type C1 Disease.
Julian Raiman, MD; Reena Sharma, MD (European Coordinating Investigator and Principal Investigator, Salford Royal Foundation Trust Hospital, Salford, UK); Martin Paucar, MD (Principal Investigator, Karolinska Institute, Stockholm, Sweden); Orna Staretz-Chacham MD (Principal Investigator, Soroka Medical Center, BeerSheva, Israel); Ronen Spiegel, MD (Principal Investigator, Emek Medical Center, Afula, Israel); Alan Boyd, MD; Caroline Hastings, MD; and Sharon Hrynkow, PhD.
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® Cyclo™, 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® Cyclo™ 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® Cyclo™ 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.
Jeffrey L. Tate, Ph.D., COO
Cyclo Therapeutics, Inc.
+1 (386) 418-8060