ALACHUA, FL -- (Marketwired) -- 04/19/17 -- CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease, today corrects false and misleading statements published on April 18 in the on-line open access journal PLOS One.
"Patients struggling with Niemann-Pick Disease Type C (NPC) deserve accurate and complete information about drug products used in clinical trials," said N. Scott Fine, Company Chairman and CEO. "The PLOS One journal does a disservice to the patient community and their caregivers, as well as to all the stakeholders whose investments have brought our company into two clinical trials."
The article states that CTD's hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™, used in its clinical programs, has different chemical and biophysical properties than another hydroxypropyl beta cyclodextrin also used in clinical programs. The article implies superiority of one version over another. CTD Holdings did not provide its clinical Trappsol® Cyclo™ material to any of the authors of the PLOS article, nor to their laboratories, to make such a comparison possible. The results in the PLOS article thus appear to be based on a different product than clincal Trappsol® Cyclo™ material. If so, the results are false and misleading.
CTD Holdings has also alerted the FDA about this second instance of false and misleading information about our product as propagated by another public company.
"We will continue to ensure that information about Trappsol® Cyclo™ in the public domain is accurate. We owe it to the families and physicians with whom we work so closely in our compassionate use program and in our clinical trials to do so," said Mr. Fine.
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
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.
LifeSci Advisors, LLC
Source: CTD Holdings, Inc.