Cyclo Therapeutics Announces Abstract Accepted for Poster Presentation at the 14th International Congress of Inborn Errors of Metabolism (ICIEM)
October 18 2021 - 8:05AM
Business Wire
Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or
the “Company”), a clinical stage biotechnology company dedicated to
developing life-changing medicines through science and innovation
for patients and families living with diseases, today announced its
abstract has been selected for poster presentation at the upcoming
14th International Congress of Inborn Errors of Metabolism (ICIEM)
being held November 21-24, 2021 in Sydney, Australia and
virtually.
Summarized below is the poster title selected for
presentation:
Title: TransportNPC: A Phase 3 global trial of Trappsol®
Cyclo™ administered intravenously to patients with Niemann-Pick
disease type C1 (NPC1) Poster Number: #445 Authors:
Gerald Cox, MD, PhD, Member of the Cyclo Therapeutics Scientific
Advisory Board and former Acting Chief Medical Officer; Sharon H.
Hrynkow, PhD, Chief Scientific Officer, Senior Vice President of
Medical Affairs of Cyclo Therapeutics; and Michael Murphy, MD, PhD,
Co-Founder, Chief Medical and Scientific Officer of Worldwide
Clinical Trials Presenter: Dr. Gerald Cox
Trappsol® Cyclo™ is Cyclo Therapeutics’ proprietary formulation
of hydroxypropyl beta cyclodextrin and in multiple clinical studies
has shown encouraging results in removal of accumulated cholesterol
in cells of NPC patients. Taking the place of the defective NPC1
protein, Trappsol® Cyclo™, with its cyclic structure, facilitates
the transport of accumulated cholesterol out of cellular lysosomes
so it can be further processed and excreted out of cells.
Trappsol® Cyclo™ is currently being evaluated in the pivotal,
Phase 3 study, TransportNPC™, for the treatment of NPC1, a rare,
progressive and fatal genetic disorder. Initial sites are in the
U.S. TransportNPC™ is a randomized, double-blind,
placebo-controlled, parallel group, multicenter study designed to
evaluate the safety, tolerability, and efficacy of 2,000 mg/kg
doses of Trappsol® Cyclo™ administered intravenously every 2 weeks
along with standard of care (SOC), compared to placebo administered
intravenously and SOC alone, in patients with NPC1. The Phase 3
study intends to enroll at least 93 pediatric (age 3 years and
older) and adult patients with NPC1 in at least 23 study centers in
9 countries. Eligible patients will be randomized 2:1 to receive
either Trappsol® Cyclo™ or a placebo. Randomization will not be
constrained based on patient age, nor will patient enrollment be
gated by patient age. The study duration is 96 weeks and includes
an interim analysis at 48 weeks.
About the 2021 ICIEM
ICIEM provides an exciting opportunity for all members of the
metabolic team to share knowledge, interact, connect and innovate.
ICIEM 2021 is taking that to the next level. The 2021 Congress will
be a compelling mix of innovative basic science and cutting-edge
translational research tempered by pragmatic medical and allied
health practitioners in the field. The Congress welcomes all
members of the metabolic team including doctors, nurses,
dietitians, scientists, counsellors and industry representatives to
convene and share the latest knowledge in our field and
network.
For more information about the Congress, please visit
iciem2021.com.
About Cyclo Therapeutics
Cyclo Therapeutics, Inc. is a clinical-stage biotechnology
company dedicated to developing life-changing medicines through
science and innovation for patients and families suffering from
disease. The Company’s Trappsol® Cyclo™, an orphan drug designated
product in the United States and Europe, is the subject of four
formal clinical trials for Niemann-Pick Disease Type C, a rare and
fatal genetic disease, (www.ClinicalTrials.gov NCT02939547,
NCT02912793, NCT03893071 and NCT04860960). 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, including, without
limitation, statements regarding the satisfaction of closing
conditions relating to the offering and the anticipated use of
proceeds from the offering. 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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version on businesswire.com: https://www.businesswire.com/news/home/20211018005178/en/
Investor Contact: JTC Team, LLC Jenene Thomas (833)
475-8247 CYTH@jtcir.com
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