• Native and Derivative Cyclodextrins trappsol

    Used in R & D and specialty manufacturing

    Read more
  • Cyclodextrin Complexes aquaplex

    Improves ingredient solubility for food, nutritional and pharmaceutical formulations

    Read more
  • API Grade Cyclodextrins trappsol cyclo

    Cyclodextrins as active pharmaceutical ingredients

    Read more

July 17, 2020

Dear NPC Families and Community, Joslyn and Justin,

Cyclo Therapeutics, Inc. has supported a role for all companies in the NPC space, recognizing that patients will ultimately benefit from multiple treatment options. Cyclo Therapeutics Inc. remains committed to move forward with our planned Phase III pivotal trial with our cyclodextrin formulation, Trappsol® Cyclo™, through Intravenous administration in patients with Niemann-Pick Disease Type C1. And, our support for the NPC community continues to be unwavering.

Our decision to develop Trappsol® Cyclo ™ through an intravenous route of administration was based on knowledge gained through our Expanded Access programs dating back to 2009: safety of the drug when provided intravenously; patient and caregiver acceptance of intravenous administration; higher safety profile for intravenous over other routes of administration; convenience to patients and families and ability to provide administration of the drugat home (as is happening now in a Cyclo Therapeutics’ extension protocol of the US Phase I trial); and benefit as measured by efficacy tools both in Expanded Access programs and now in the formal clinical trials.

Cyclo Therapeutics recently closed its Phase I safety trial of intravenous Trappsol® Cyclo™ cyclodextrin and reported top line results. The safety profile, as expected, was highly favorable, and it validated 10 years’ of safety data from Expanded Access programs.In addition, Cyclo Therapeuticsrecently reported the Interim Analysis of our Phase I/II trial, showing signals of efficacy in all dose groups studied. While the Phase I/II trial will not be completed until early 2021, there are compelling individual examples of drug benefit showing improvements in walking, speaking, word finding ability, and fine motor skills underpinning activities of daily living.

We look forward to continuing to collaborate with patients, families, physicians and health agencies with the intention of launching ourPhase III intravenous cyclodextrin trial in 4Q2020.

Sincerely,

Dr. Sharon H. Hrynkow
Chief Scientific Officer and
Senior Vice President for Medical Affairs
Cyclo Therapeutics, Inc.
Sharon.Hrynkow@cyclodex.com

Recent News:

  • Oct 21 2020, 10:53 AM EDT Cyclo Therapeutics Phase 3 Pivotal Program Can Begin Enrollment Per US FDA
  • Sep 21 2020, 8:00 AM EDT Cyclo Therapeutics to Present at 2020 Annual Conference for NPC Patients, Families, and Health Professionals in the United Kingdom
  • Sep 8 2020, 8:38 AM EDT Cyclo Therapeutics Inc. Announces Additional Efficacy Data from its Ongoing Phase I/II Trial using Trappsol® CycloTM Intravenously to Treat Patients with Niemann-Pick Disease Type C1 (NPC1)