International Niemann–Pick Disease Alliance
CTD Holdings Announces Grant to U.S. Non-Profit Organization to Support Patient Participation in Informational Meetings with Regulators
Support is part of CTD’s efforts to recognize Rare Disease Day 2019
ALACHUA, FL – (Globe Newswire) – February 28, 2019 – CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, today announces its support for the National Niemann-Pick Disease Foundation (NNPDF), the U.S. national advocacy organization for patients with Niemann-Pick Disease Type C (NPC). The grant from CTD is for $10,000. Funds will be used to support travel costs for patients with NPC and their families to participate in meetings with U.S. regulators as part of increasing efforts for patient participation in drug development conversations.
“Today, we recognize all of the families and patients suffering from rare diseases and their heroic efforts to identify and support potential cures and treatments,” said CTD Chairman and CEO N. Scott Fine. “Because of patient and family efforts, our company’s program to build clinical trials in support of treatments for Niemann-Pick Disease Type C was launched and is now producing initial trial data. We are proud to support NPC patients and families as they travel to inform and inspire us on our drug development pathway.”
Funds will be used initially to support NPC patient and family travel to attend a “Patient-Focused Drug Development” meeting to be convened in Hyattsville, Maryland on March 18, 2019. Remaining funds will be used by NNPDF to support NPC patient and family participation at future meetings related to the drug development and clinical trial process.
“We are pleased to partner with CTD Holdings in support of NPC patients and their families,” said Joslyn Crowe, Executive Director of NNPDF. “Support of private sector entities such as CTD is vital as we work to bring patient voices to the forefront, and to the regulatory authorities who oversee the approval process for drugs that will directly impact their lives.”
Niemann-Pick Disease Type C is a rare and fatal genetic disorder characterized by cholesterol accumulation in every cell of the body. There are no approved treatments in the US and only one in the EU. CTD Holdings supports clinical trials using Trappsol® Cyclo™, its proprietary formulation of hydroxypropyl beta cyclodextrin, administered intravenously. In the United States, CTD’s Phase I Clinical Trial is open for enrollment at Children’s Hospital Oakland and, for NPC patients over the age of 18 years, in Morristown, New Jersey. An Extension Protocol for this trial is also approved. In Europe and Israel, a Phase I/II Trial is completing enrollment (See NCT02939547 and NCT02912793). Initial findings from the U.S. study and its companion Phase I/II trial in Europe and Israel were recently reported (CTD’s clinical data press release).
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, on a compassionate use basis as well as in two ongoing formal clinical trials (Clinical Trials.gov NCT02939547 and NCT02912793). Additional indications for the active ingredient in Trappsol® Cyclo™ are in development. For additional information, visit the company’s website: www.ctd-holdings.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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