GAINESVILLE, Fla. –
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 it has submitted its initial
investigational new drug (“IND”) application with the U.S. Food and Drug
Administration (“FDA”) for a Phase 2 study of Trappsol® Cyclo™ for the treatment of early Alzheimer’s Disease (AD).
“We are excited to have submitted our Initial IND to evaluate Trappsol®
Cyclo™ for the treatment of Alzheimer’s Disease. The feedback and
recommendations received from our Type B Meeting with the FDA have
provided valuable input that we believe positions us for success in
advancing this asset. We have taken another step towards commencing our
Phase 2 study and, importantly, bringing a much-needed treatment option
to patients and families,” commented Michael Lisjak, Chief Regulatory
Officer, Senior Vice President for Business Development of Cyclo
Therapeutics.
Trappsol® Cyclo™ is a proprietary formulation of
hydroxypropyl beta cyclodextrin and in multiple clinical studies has
shown encouraging results to effectively manage the transportation of
cholesterol. Many of the known risk factors for AD are associated with
cholesterol metabolism. Cholesterol imbalance in AD patients is well
known, and significant research exists suggesting these imbalances are
responsible for Aβ and tau accumulation. Furthermore, neurons, because
of their high metabolic demands, experience an increased level of
oxidative stress. Oxidative stress has also been linked to abnormal
cholesterol accumulation and processing. AD shares features with NPC-1, a
neurovisceral, genetic disease in which cholesterol accumulates in
lysosomes, including progressive decline in cognitive ability, amyloid
beta plaques in the CNS, and increased levels of tau in the
cerebrospinal fluid (CSF). Cyclo Therapeutics is currently testing the
same investigational Trappsol® Cyclo™ drug in clinical trials
for the treatment of Niemann-Pick Disease Type C1 (NPC-1). Taking the
place of the defective NPC-1 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.
“There remain significant unmet needs within the Alzheimer’s Disease community, which we believe Trappsol®
Cyclo™ is well-positioned to address. We are committed to advancing
this important program as quickly and efficiently as possible following
feedback from FDA in the coming weeks,” added N. Scott Fine, Chief
Executive Officer of Cyclo Therapeutics.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive neurologic disorder that causes the
brain to shrink (atrophy) and brain cells to die. Estimates vary, but
experts suggest that more than 5.5 million Americans, most of them age
65 or older, may have dementia caused by Alzheimer’s. Most people with
Alzheimer’s have the late-onset form of the disease, in which symptoms
become apparent in their mid-60s. Early-onset Alzheimer’s disease occurs
between a person’s 30s and mid-60s and represents less than 10 percent
of all people with Alzheimer’s. The early signs of the disease include
forgetting recent events or conversations. As the disease progresses, a
person with Alzheimer’s disease will develop severe memory and thinking
skills impairment, then lose ability to learn, reason, make judgments,
communicate and carry out daily activities. Medications may temporarily
improve or slow progression of symptoms, however there is currently no
treatment that cures Alzheimer’s disease or alters the disease process
in the brain.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211116005289/en/
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
[email protected]
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