Cyclo Therapeutics Recognizes Niemann-Pick Disease Awareness Month Highlighting Need for Broader Awareness and Support for Research to Find a Treatment

Rhea-AI Summary

Cyclo Therapeutics (NASDAQ: CYTH) is participating in Niemann-Pick Disease Awareness Month to raise awareness of Niemann-Pick Disease (NPC), a rare genetic disorder impacting 1 in 100,000 live births. The company emphasizes the need for treatment options and support for affected families. Cyclo Therapeutics is actively advancing its pivotal Phase 3 clinical trial, TransportNPC™, and has launched NPCspotlight.com for additional information. The CEO highlights the urgency of research and community support.

Positive

• Engaging in initiatives to raise awareness of Niemann-Pick Disease.
• Participation in a pivotal Phase 3 clinical trial, TransportNPC™, currently enrolling patients.
• Launch of NPCspotlight.com to provide information and support.

Negative

• None.

Company engaged in ongoing initiatives to help raise awareness and provide information on research and support for patients and families

GAINESVILLE, Fla.--(BUSINESS WIRE)-- Cyclo Therapeutics, Inc. (Nasdaq: CYTH), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today joins with the global Niemann-Pick Disease community in recognizing Niemann-Pick Disease Awareness Month, an initiative to build broader awareness of the impact this disease has on patients, families, and caregivers across the globe.

“As a company dedicated to advancing research to develop a treatment for Niemann-Pick Disease Type C (NPC), we are honored to commemorate Niemann-Pick Disease Awareness Month and join with the entire community in reinforcing the critical need for broader disease awareness, more services for families and caregivers, and support for research that can lead to the first approved therapy in the U.S. for a community in desperate need of treatment options,” said Scott Fine, CEO of Cyclo Therapeutics. “We also acknowledge the many leaders from the NPC community who have joined in efforts to share their stories and have made the important decision to participate in clinical research.”

NPC is a rare, progressive and fatal genetic disorder characterized by abnormal accumulation of cholesterol in cells. Symptoms of the disease include enlarged liver or spleen, difficulties with motor skills, speech, swallowing and feeding as well as cognitive impairment.

In honor of Niemann-Pick Disease Awareness Month, Cyclo Therapeutics will be engaging in several initiatives to help raise awareness and provide information on research and support for patients and families. These include:

• Participation in an informational webinar in collaboration with the National Niemann-Pick Disease Foundation (NNPDF) to provide an update on the Company’s pivotal Phase 3 clinical trial, TransportNPC™, that is currently enrolling patients at treatment centers in the U.S. and around the world. A replay of this event is available at www.nnpdf.org.
• The launch of NPCspotlight.com, a new website with information about the disease and perspectives from patients and others about living with NPC.
• A community newsletter with updates on progress in the Company’s research efforts.

“We have heard from so many patients and families about how much they need a treatment to be available for NPC, and Niemann-Pick Disease Awareness Month is an important time to renew our focus on moving promising research forward,” said Lisa Kjems, MD, PhD, the Company’s Chief Medical Officer. “We are very grateful to all of the patients and families who are supporting our efforts to develop a treatment for NPC. Their bravery and dedication inspire our work every day.”

About Niemann-Pick Disease Type C1 (NPC)

NPC is a rare genetic disease affecting 1 in 100,000 live births globally. Approximately 95% of individuals with NPC have mutations in the NPC1 gene and 5% have mutations in the NPC2 gene. NPC affects nearly every cell in the body due to a deficiency in either the NPC1 or NPC2 protein, which are required for the transport and processing of cholesterol within the cell. As cholesterol accumulates within cells, NPC causes symptoms that affect the brain, liver, spleen, lung, and other organs and often leads to premature death.

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/20211019005723/en/

Investor Contact:

JTC Team, LLC

Jenene Thomas

(833) 475-8247

CYTH@jtcir.com

Source: Cyclo Therapeutics, Inc.

FAQ

What is Cyclo Therapeutics' involvement in Niemann-Pick Disease Awareness Month?

Cyclo Therapeutics is participating in Niemann-Pick Disease Awareness Month to raise awareness and support for research into Niemann-Pick Disease.

What is the status of Cyclo Therapeutics' TransportNPC™ clinical trial?

TransportNPC™, Cyclo Therapeutics' pivotal Phase 3 clinical trial, is currently enrolling patients in the U.S. and globally.

What initiatives is Cyclo Therapeutics engaging in for Niemann-Pick Disease awareness?

Cyclo Therapeutics is hosting an informational webinar and launched NPCspotlight.com to educate about Niemann-Pick Disease.

What is Niemann-Pick Disease?

Niemann-Pick Disease is a rare, progressive genetic disorder that causes harmful cholesterol accumulation in cells, affecting multiple organs.

How common is Niemann-Pick Disease?

Niemann-Pick Disease affects approximately 1 in 100,000 live births worldwide.