International Niemann–Pick Disease Alliance
Available for download, here
ALACHUA, FL – (Marketwired) – 06/27/17 – CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease, today announced that the company has shipped 660 additional vials of its Trappsol® Cyclo™ product to the government of Brazil under a business relationship now in its seventh year.
CTD’s orphan drug designated Trappsol® Cyclo™ is being developed for the treatment of Niemann-Pick Disease Type C (NPC). CTD is currently recruiting for a Phase I study in the U.S. and a Phase I/II clinical trial in the EU to evaluate its proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™, to treat NPC, a rare and fatal genetic disease that damages the brain, lung, liver, spleen, and other organs. Trappsol® Cyclo™ is also being used as an investigational new drug for the treatment of NPC in ongoing programs in the US, Europe and Brazil.
CTD has an exclusive supplier agreement with the government of Brazil and distributes to the country through its exclusive distribution partner UnoHealthcare of Miami, FL.
“We are pleased to continue supplying Brazilian NPC patients with Trappsol® Cyclo™,” stated N. Scott Fine, CTD Chairman & CEO. “We are the only source of cyclodextrins for these patients, and we are grateful to the families and physicians who have shared their treatment data with us. Their data have been instrumental in the advancement of our global clinical trial program.”
Upon completion of the current shipment, CTD has supplied more than 7200 vials of liquid Trappsol® Cyclo™ and more than 200 kg of powdered first-generation product to the government in Brazil for compassionate treatment of NPC. CTD has been supplying Trappsol® Cyclo™ to Brazil for treatment of NPC since 2010. Treatment of NPC patients in Brazil is under the direct care of their physicians and in conformance with all regulatory requirements of the Brazilian Health Survey Agency (ANVISA).
CTD previously received Fast Track Designation and Orphan Drug Designation for the use of Trappsol® Cyclo™ in the treatment of NPC from the U.S. Food and Drug Administration and the European Medicines Agency.
About CTD Holdings: CTD Holdings, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease. The company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is used to treat Niemann-Pick Disease Type C, a rare and fatal genetic disease. Additional indications for the active ingredient in Trappsol® Cyclo™, are in development. For additional information, visit the company’s website: www.ctd-holdings.com.
This press release contains “forward-looking statements” about the company’s current expectations about future results, performance, prospects and opportunities. 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.
LifeSci Advisors, LLC