Company Will Present the Design of an Intravenous Treatment Study
ALACHUA, FL -- (Marketwired) -- 08/24/15 -- CTD Holdings, Inc. (OTCQB: CTDH), a biotechnology company that is developing Trappsol® Cyclo™ as a treatment for Niemann-Pick Type C (NPC) disease, today announced that the company has set a meeting with a European health authority to discuss its initial clinical development plans. These plans have been based upon extensive discussions with clinical experts, some of whom have more than five years of experience from the compassionate use of Trappsol® Cyclo™ in the management of NPC patients.
CTD's planned clinical trial protocol for intravenous (I.V.) administration of Trappsol® Cyclo™ addresses the systemic nature of the NPC disease. The study will investigate endpoints relating to safety and efficacy. It is the first step in a program to formally evaluate I.V. rather than a more invasive route of administration.
Niemann-Pick Type C is a systemic disease caused by a defective gene that affects every cell in the body and interferes with normal cholesterol processing. The disease is variable in severity. Many NPC patients suffer from damage to liver and lung cells in addition to neurologic damage. Severe cases of NPC lead to early death, often by adolescence.
"We look forward to this next important step as CTD moves its global clinical trial for Trappsol® Cyclo™ forward," said Executive Chairman N. Scott Fine.
Internationally known Pharmaceutical Physician Professor Alan Boyd, who is part of the CTD clinical team added, "Clinical trials in rare disease require collaboration of many agencies and patient groups. I look forward to the meeting with regulatory authorities as a pivotal moment in the CTD international clinical program."
CTD Holdings has been developing Trappsol® Cyclo™ for NPC patients since 2008. The product is a designated orphan drug in the U.S. and Europe and has been used in the treatment of more than 20 NPC patients worldwide, in the U.S. under individual investigational new drug protocols, in Europe and Brazil on a named patient compassionate use basis. Trappsol® Cyclo™ has been administered intravenously, intrathecally and intracerebroventricularly.
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 serious 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.
Source: CTD Holdings, Inc.