Cyclo Therapeutics, Inc.
Cyclo Therapeutics, Inc. is focused on the use of cyclodextrins in drug development in treatment for Niemann-Pick disease Type C (NPC). The mission of Cyclo Therapeutics, Inc. is to develop, manufacture, and distribute cyclodextrin-based high value products. Their products treat disease, improve quality of life, and provide solutions in a broad range of applications including pharmaceutical formulation, medical diagnostics, cosmetics, nutraceuticals, and nutrition.
For more information, please visit cyclotherapeutics.com.
This page is dedicated to news and information about Cyclo Therapeutic’s therapies for use in Niemann-Pick disease Types C (NPC). Information is released as it becomes available.
Patient and Trial Information
Lise Kjems, Chief Medical Officer
lise.kjems@cyclodex.com
Lori Gorski, Patient Liaison
lori.gorski@cyclodex.com
- Clinical Trial Information
- Transport NPC
- NPC Spotlight Spotlight on Niemann-Pick disease type C
Latest News
Update from Cyclo Therapeutics
Cyclo Therapeutics announces positive outcome from type C meeting with the U.S. FDA discussing Trappsol® Cyclo™ Clinical Program for the treatment of Niemann-Pick Disease type C1. Read complete announcement.
12/18/2023
Update from Cyclo Therapeutics
Cyclo Therapeutics published positive data from their Phase 2 study of Trappsol Cyclo in the journal of Molecular Genetics and Metabolism Reports. Read the full press release which includes additional commentary from the principal investigator, Dr. Caroline Hastings.
06/29/2023
Update from Cyclo Therapeutics
Dr. Caroline Hastings, Global Principal Investigator and Head of the Global Steering Committee for the Phase 3 study TransportNPC™ shares an update on their progress to date to advance this pivotal study in patients with Niemann-Pick Type C1. Read the update.
06/09/2023
Update from Cyclo Therapeutics
We are continuing our Phase 3 study TransportNPC™ (Intravenous 2-hydroxypropyl-ß-cyclodextrin), to evaluate the safety and efficacy of a potential disease modifying therapy to treat NPC. This is the most extensive and advanced study underway in NPC and we are pleased to let you know that we are approximately 50% enrolled, and on track to complete enrollment by the end of this year. This is a large global study, and our sites in the United States are quite active, including:
- UCSF Benioff Children’s Hospital Oakland
- Cincinnati Children’s Hospital Medical Center
- UPMC Children’s Hospital (Pittsburgh)
- Lysosomal and Rare Disorders Research & Treatment Center (Fairfax, Virginia)
We understand that participating in a clinical trial is a big commitment, both for patients and their caregivers. We are pleased to share that within the United States, participants in this study will have the option of receiving their biweekly infusions at home. While some visits to your clinical trial site are still required, many of your infusions may be given at home. We hope giving patients and caregivers the option to remain at home will reduce travel and daily living disruptions and allow patients to receive the study infusion in the comfort of their home surrounded by loved ones.
We look forward to connecting with those of you attending the NNPDF annual meeting in Orlando. For any questions about Cyclo or TransportNPC™, contact lori.gorski@cyclodex.com.
05/30/2023
Cyclo Therapeutics’ May 2023 newsletter is live. Senior Medical Science Liaison, Joseph Mejia, MD shares an update on Phase 3 Study home infusion availability and get to know our very own Laurie Turner, NNPDF Family Services Manager. Read more.
05/01/2023
Cyclo Therapeutics’ January 2023 newsletter is live. Scott Fine, CEO shares an update on their ongoing Phase 3 study, TransportNPC™ and a recap of key activities delivered last year. Read more.
01/18/2023
Cyclo Therapeutics provides clinical program update and highlights recent achievements. Read complete update.
01/13/2023
Cyclo Therapeutics announces the publication of Phase 1 data for Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease type C1. Read complete update.
10/19/2022
Cyclo Therapeutics announces the formation of a Global Steering Committee comprised of leading experts to advise on the global Phase 3 clinical development program for Trappsol® Cyclo™ in Niemann-Pick Disease Type C. Read complete update.
02/03/2022
The following update has been shared with the NNPDF from Cyclo Therapeutics on their TransportNPC trial, which is currently enrolling. Read complete update.
12/21/2021
Cyclo Therapeutics Appoints Caroline Hastings, M.D. as Global Principal Investigator for Ongoing TransportNPC™ Study evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease. Read full press release.
12/10/2021
The following update has been shared with the NNPDF from Cyclo Therapeutics on their TransportNPC trial, which is currently enrolling. Read complete update.
10/12/2021
Cyclo Therapeutics announces their design of pivotal Phase 3 study evaluating Trappsol® Cyclo™ in Niemann-Pick Type C1 patient enrollment is on track to commence in Q2 2021. For complete announcement click here.
04/27/2021
Cyclo Therapeutics announces their Phase III pivotal trial using Trappsol® Cyclo™ will be enrolling soon. For complete announcement click here.
04/14/2021
Cyclo Therapeutics Meets Primary Efficacy Endpoint in Phase 1/2 Trial from Intravenous Trappsol® Cyclo™ in Rare Disease Niemann-Pick Type C1 (NPC1). For complete announcement click here.
03/25/2021
Cyclo Therapeutics receives positive opinion from the Paediatric Committee of the European Medicines Agency on the agreement of a paediatric investigation plan for Trappsol® Cyclo™. For complete announcement click here.
03/09/2021
Cyclo Therapeutics, Inc. announces it’s last patient last visit in their Phase 1/2 Trial Evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick disease Type C. For complete announcement click here.
03/04/2021
Cyclo Therapeutics Presents Positive Data from Clinical Development Program for Lead Candidate, Trappsol® Cyclo™, at WORLDSymposium 2021. For complete announcement click here.
02/09/2021
Cyclo Therapeutics to Present on Its Clinical and Drug Development Program for Lead Candidate, Trappsol® Cyclo™, at WORLDSymposium 2021. For complete announcement click here.
01/26/2021
Cyclo Therapeutics Announces Positive Efficacy Data from Extension Protocol with Trappsol® Cyclo™ in Patients with Niemann-Pick disease Type C. For complete announcement click here.
01/05/2021
Cyclo Therapeutics announces Two Presentations at WORLDSymposium2021.
CLICK HERE For complete announcement.
11/19/2020
Cyclo Therapeutics announces its Phase 3 pivotal program can begin enrollment of Trappsol® Cyclo™ for treatment of Niemann-Pick disease Type C.
CLICK HERE For complete announcement.
10/21/2020
Cyclo Therapeutics to Present at 2020 Annual Conference for NPC Patients, Families, and Health Professionals in the United Kingdom
CLICK HERE for complete announcement.
09/21/2020
Cyclo Therapeutics Inc. Announces Additional Efficacy Data from its Ongoing Phase I/II Trial using Trappsol® Cyclo™ Intravenously to Treat Patients with Niemann-Pick disease Type C1 (NPC1)
CLICK HERE for complete announcement.
09/08/2020
Cyclo Therapeutics Closes $2.8 Million Private Placement led by Novit LP with $1.0 Million
CLICK HERE for complete announcement.
08/27/2020
A Message from Cyclo Therapeutics to the NPC Community
CLICK HERE for complete announcement.
07/17/2020
Cyclo Therapeutics’ Clinical Data Webinar Recording Available on Company Website
CLICK HERE for complete announcement.
05/28/2020
Cyclo Therapeutics Inc. Announces Positive Top Line Results from Phase I Trial and Interim Analysis of Phase I/II Trial using Trappsol® Cyclo™ Intravenously to Treat Patients with Niemann-Pick disease Type C1 (NPC1)
CLICK HERE for complete announcement.
05/20/2020
Cyclo Therapeutics to Hold Call for Patients and Investors Wednesday, May 20 at 4:30 pm EDT
CLICK HERE for complete announcement.
05/19/2020
Cyclo Therapeutics Announces Positive Feedback from European Medicines Agency on its Pivotal Trial Design for Trappsol® Cyclo™ for Niemann-Pick disease Type C1
CLICK HERE for complete announcement.
05/19/2020
Cyclo Therapeutics Inc. Announces $2.0 Million Private Placement Closing
CLICK HERE for complete announcement.
04/27/2020
Cyclo Therapeutics Inc. Announces Positive Safety Profile of its Drug Trappsol® Cyclo™ in the Treatment of Niemann-Pick disease Type C
CLICK HERE for complete announcement.
03/23/2020
Cyclo Therapeutics Announces Positive Feedback from FDA on its Pivotal Trial Design for Trappsol® Cyclo™ for Niemann-Pick disease Type C1
CLICK HERE for complete announcement.
03/02/2020
Cyclo Therapeutics Announces Completion of Enrollment in its Phase I/II Trial to Evaluate Trappsol® Cyclo™ for the Treatment of Niemann-Pick disease Type C
Cyclo Therapeutics, Inc. today announced that it has completed patient enrollment in its Phase I/II trial to evaluate the safety, tolerability, and efficacy of Trappsol® Cyclo™ administered intravenously to Niemann-Pick disease Type C1 (NPC1) patients.
CLICK HERE FOR COMPLETE ANNOUNCEMENT
02/20/2020
Last Patient Last Visit in Cyclo Therapeutics’ Phase I Trial in Niemann-Pick Type C
Cyclo Therapeutics, Inc. today announced that the last patient has undergone the final assessment in its Phase I trial to evaluate the safety and tolerability of Trappsol® Cyclo™ administered intravenously to NPC patients.
CLICK HERE FOR COMPLETE ANNOUNCEMENT
02/12/2020
Cyclo Therapeutics, Inc. Poster Presentation of Clinical Trial Data on Niemann-Pick Type C Disease at the 16th Annual WORLDSymposium Now Available
CLICK HERE FOR COMPLETE ANNOUNCEMENT
02/05/2020
Cyclo Therapeutics to Present Clinical Trial Data on NPC at 2020 WORLDSymposium
CLICK HERE FOR COMPLETE ANNOUNCEMENT
12/18/2019 jjb
Cyclo Therapeutics Signs Agreement with Worldwide Clinical Trials to Conduct Pivotal Trial in Niemann-Pick disease Type C
CLICK HERE FOR COMPLETE ANNOUNCEMENT
11/8/2019 jjb
Cyclo Therapeutics Announces Its Publication of the Most Extensive Set of Case Study Reports To-date on Expanded Access Use of Hydroxypropyl Beta Cyclodextrin in Niemann-Pick disease Type C.
CLICK HERE FOR COMPLETE ANNOUNCEMENT
10/31/2019 jjb
Cyclo Therapeutics Announces Completion of Enrollment in its Phase I Trial to Evaluate Trappsol® Cyclo™ for the Treatment of Niemann-Pick disease Type C.
CLICK HERE FOR COMPLETE ANNOUNCEMENT
10/22/2019 jjb
Cyclo Therapeutics, Inc. Announces Maurizio Scarpa, MD as EU Coordinating Investigator for the Company’s Pivotal Trial in Niemann-Pick disease Type C.
CLICK HERE FOR COMPLETE ANNOUNCEMENT
10/09/2019 jjb
CTD Holdings Announces FDA Approval of US Expanded Access Treatment Program in Niemann-Pick disease Type C.
CLICK HERE FOR COMPLETE ANNOUNCEMENT
09/14/2019 jjb
CTD Announces New Data Presented at Annual Gathering of Patients and Families Tackling NPC.
CLICK HERE FOR COMPLETE ANNOUNCEMENT
08/14/2019 jjb
CTD Holdings, Inc. Appoints Head of Global Affairs
CTD Holdings, Inc. is pleased to announce the appointment of Mr. Michael Lisjak as Global Head of Regulatory Affairs and Senior Vice President for Business Development.
CLICK HERE FOR COMPLETE ANNOUNCEMENT
07/08/2019 jjb
CTD Holdings, Inc. Announces Closing on $7.4 Million Private Placement.
CLICK HERE FOR COMPLETE ANNOUNCEMENT
05/31/2019 jjb
CTD Holdings, Inc. Announces Home-Based Dosing of First Patient in US Extension Protocol of Clinical Trial using Intravenous Administration of Trappsol® Cyclo™ for NPC
CLICK HERE FOR COMPLETE ANNOUNCEMENT
05/23/2019 jjb
CTD Holdings, Inc. Shares Update on Ongoing Recruitment for Niemann-Pick Type C1 Study
04/10/2019 jjb
NNPDF Industry Update Webinar Series featuring CTD Holdings, Inc.
03/15/2019 jjb
Additional Travel Funding For Those Participating in PFDD Meeting
CTD Holdings is providing funding through NNPDF to support families with travel assistance to the upcoming NPC Externally-Led Patient-Focused Drug Development Meeting (PFDD). Support is intended for additional family members who would like to attend the meeting but are not eligible for subsidy otherwise. As the national patient organization, NNPDF is glad to assist in providing this support to the Niemann-Pick community.
Externally-led PFDD events are driven by people with NPC and their advocates to provide the FDA with personal perspectives and experiences from the community, including challenges faced on a daily basis in living with NPC and hopes for future treatments. It seeks to better emphasize the voice of the patient in the therapy development process so that these therapies are better tailored to the needs and preferences of patients.
For more information on how to apply for this financial assistance, please contact Laurie Turner, Family Services Manager at familyservices@nnpdf.org.
For more information on the PFDD, or to register for the event, visit niemannpickc-pfdd.com.
2/28/2019 jjb
CTD Reports Initial Data for Two Clinical Trials of Trappsol® Cyclo™ Provided Intravenously for Patients with Niemann-Pick Disease Type C
CLICK HERE FOR COMPLETE ANNOUNCEMENT
2/7/2019 jjb
CTD Holdings Announces Partnership with United BioSource LLC to support the Extension Protocol for its Phase I Clinical Trial in the US
CLICK HERE FOR COMPLETE ANNOUNCEMENT
1/18/2019 jjb
CTD Holdings to Present at Upcoming Brains for Brain Conference on Lysosomal Storage Diseases
CLICK HERE FOR COMPLETE ANNOUNCEMENT
1/10/2019 jjb
CTD Holdings to Present at WORLD Symposium on Lysosomal Storage Diseases
CLICK HERE FOR COMPLETE ANNOUNCEMENT
Phase I Study using Trappsol® Cyclo™ Abstract
Phase I/II Study using Trappsol® Cyclo™ Abstract
12/12/2018 jjb
CTD Announces Partnership with Synteract to support the Extension Protocol for its Phase I Clinical Trial in the United States
CLICK HERE FOR COMPLETE ANNOUNCEMENT
11/8/2018 jjb
CTD Holdings Posts Recording of its Webinar on US Clinical Trial
CLICK HERE FOR COMPLETE ANNOUNCEMENT
10/19/2018 jjb
CTD Holdings Announces Plans to Broaden its Expanded Access Program for Trappsol® Cyclo™
CLICK HERE FOR COMPLETE ANNOUNCEMENT
10/16/2018 jjb
CTD Holdings to Host Webinar on its Phase I Clinical Trial for Niemann-Pick disease Type C
CLICK HERE FOR COMPLETE ANNOUNCEMENT
10/11/2018 jjb
CTD Holdings Establishes Second Clinical Trial Site for US Phase I Clinical Study of Trappsol® Cyclo™ for Treatment of NPC
CLICK HERE FOR COMPLETE ANNOUNCEMENT
10/05/2018 jjb
CTD Holdings Announces Top-line Data from Two Ongoing Clinical Trials of Trappsol® Cyclo™ Administered Intravenously in NPC
CLICK HERE FOR COMPLETE ANNOUNCEMENT
10/03/2018 jjb
CTD Holdings Discusses its Phase I Clinical Trial for Intravenous Use of Trappsol® Cyclo™ in Niemann-Pick disease Type C
CLICK HERE FOR COMPLETE ANNOUNCEMENT
08/30/2018 jjb
FDA Authorizes CTD to Proceed with Extension Protocol to US Phase I Trappsol® Cyclo™ Trial for NPC
CLICK HERE FOR COMPLETE ANNOUNCEMENT
04/30/2018 jjb
CTD Holdings Conducts Initial Review of Safety Data for its Phase I and Phase I/II Trials of Trappsol® Cyclo™ to Treat Niemann-Pick disease Type C
CLICK HERE FOR COMPLETE ANNOUNCEMENT
03/29/2018 jjb
CTD Holdings’ European Clinical Trial Adopted by National Institute for Health Research of England
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01/17/2018 jjb
CTD Holdings Receives Rare Pediatric Disease Designation for Trappsol(R) Cyclo(TM)
CLICK HERE FOR COMPLETE ANNOUNCEMENT
12/6/2017 cdk
CTD Holdings Enrolls First Patient in
US Phase I Clinical Trial of Trappsol(R) Cyclo(TM)
for Treatment of Niemann-Pick disease Type C
CLICK HERE FOR COMPLETE ANOUNCEMENT
09/28/2017 jjb
CTD Holdings Announces Approval of Clinical Trial
Application to Conduct Phase I/II Clinical Study
of Trappsol(R) Cyclo(TM) in Patients with
Niemann-Pick Type C Disease in Israel
CLICK HERE FOR COMPLETE ANNOUNCEMENT
CTD Holdings Announces First Patient Dosed in
Phase I/II Clinical Trial to Evaluate Trappsol(R)
Cyclo(TM) in Niemann-Pick disease Type C
CLICK HERE FOR COMPLETE ANNOUNCEMENT
07/20/2017 jjb
CTD Holdings Ships Additional
Trappsol® Cyclo™ to Brazil
06/27/2017 jjb
CTD Holdings Enrolls First Patient in European Phase I/II Clinical Trial of Trappsol® Cyclo™ for Treatment of Niemann-Pick disease Type C
CLICK HERE FOR COMPLETE ANNOUNCEMENT
06/21/2017 jjb
CTD WEBINAR Clinical Program Update on Trappsol® Cyclo™ Drug Development Program for NPC Treatment
6/13/2017 jjb
CTD Holdings to Host Webinar to Provide Update on Trappsol® Cyclo™ Drug Development Program for NPC Treatment
CLICK HERE FOR MORE INFORMATION
5/16/2017 jjb
CTD Holdings Initiates Recruitment for Phase I/II Clinical Study in Europe of Trappsol® Cyclo™ for Treatment of Niemann-Pick disease Type C
CLICK HERE FOR FULL ANNOUNCEMENT
03/21/2017 jjb
CTD Holdings Closes $2 Million Private Placement
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02/23/2017 jjb
CTD Holdings Presents Compassionate Use Data on Trappsol(R) Cyclo(TM) to Treat Niemann-Pick disease Type C and Provides Update on Progress of U.S. and EU Clinical Trials at 13th Annual WORLDSymposium
CLICK HERE FOR FULL ANNOUNCEMENT
02/20/2017 jjb
FDA Grants Fast Track Designation for Trappsol (R) Cyclo(TM) in Drug Development Program for NPC
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01/17/2017 jjb
CTD Holdings Files Clinical Trial Application with Italian Drug Agency to Continue Advancing Trappsol(R) Cyclo(TM) Drug Development Program to Treat Niemann-Pick disease Type C
CLICK HERE FOR FULL ANNOUNCEMENT
12/22/2016 jjb
CTD HOLDINGS IV TRAPPSOL CYCLO STUDY
The NNPDF Central Office has received notice that CTD’s US trial parameters for the IV Trappsol Cyclo study in NPC are now published at Clinical Trials.Gov.
CTD HOLDINGS PRESS RELEASE
CTD Holdings Announces MHRA Approval of Clinical Trial Application for Treatment of NPC With Trappsol(R) Cyclo(TM)