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ALACHUA, FL--(Marketwired - August 07, 2015) - CTD Holdings, Inc. (OTCQB: CTDH), a biotechnology company that develops cyclodextrin-based products for the treatment of disease, today announced that the company will donate $1 million of its investigational drug, Trappsol® Cyclo™, to eligible Niemann-Pick Type C (NPC) patients participating in CTD's newly-created expanded access program.
Under this program, Trappsol® Cyclo™ is available prior to its regulatory approval to patients whose physicians have received regulatory permission to use the drug to treat NPC, a rare and serious disease found primarily in children.
"The needs of NPC patients and their families are CTD's top priority and concern," said CTD Executive Chairman Scott Fine. "Our expanded access program addresses the challenges faced by NPC families in obtaining Trappsol® Cyclo™ before it has received market authorization."
Dr. Sharon Hrynkow, a member of CTD's Scientific Advisory Board and Senior Medical Advisor to the company, added: "CTD has worked with dozens of NPC families worldwide and we truly understand the pressures they face. We believe our expanded access program will help ease these pressures as we work towards obtaining regulatory approval for Trappsol® Cyclo™."
CTD Holdings has been supplying Trappso® Cyclo™ to NPC patients and their physicians, under appropriate regulatory controls, worldwide since 2009. In the U.S. patients are treated under FDA Investigational New Drug (IND) protocols supervised by a physician with permission under the FDA's expanded access or "compassionate use" program. In other parts of the world the treatment is often carried out under a named patient program using an established treatment protocol that is supervised by a physician.
You can learn more about CTD's Trappsol® Cyclo™ expanded access program and how to participate here: www.trappsolcycloaccess.com. You may also email your questions to firstname.lastname@example.org.
About the Company:
CTD Holdings, Inc. is a biotechnology company developing cyclodextrin-based products for the treatment of disease, including Trappsol® Cyclo™, an orphan drug designated product, for the treatment of Niemann-Pick Type C, a rare and fatal genetic disease in young children. Additional indications for the active ingredient in Trappsol® Cyclo™, including peripheral artery disease, diabetic nephropathy, and acute viral infections, are also in development.
The company's other divisions distribute and manufacture the trademarked Trappsol® and Aquaplex® cyclodextrins, cyclodextrin derivatives, and cyclodextrin complexes for biotechnology and life science companies involved in the research, pharmaceutical, medical device, cosmetics and nutrition markets. They also operate the world's only cGMP pulse drying facility for the production of UltraPure™ cyclodextrin derivatives and pharmaceutical grade Aquaplex® cyclodextrin complexes and supply cyclodextrins to biotechnology and life science researchers around the globe from the world's largest catalog of cyclodextrins. For additional information, visit the Company's websites: www.ctd-holdings.com and www.cyclodex.com.
Safe Harbor Statement:
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.
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