SOURCE: CTD Holdings, Inc.

CTD Holdings, Inc. Logo

March 21, 2017 08:00 ET

CTD Holdings Initiates Recruitment for Phase I/II Clinical Study in Europe of Trappsol® Cyclo™ for Treatment of Niemann-Pick Disease Type C

Initial Patients to be Enrolled at Salford NHS Trust UK

ALACHUA, FL--(Marketwired - March 21, 2017) - CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease, today announced that it has begun recruiting patients at Salford NHS Trust UK for the Company's Phase I/II clinical study in Europe that will evaluate the intravenous administration of Trappsol® Cyclo™ in patients with Niemann-Pick Disease Type C (NPC), a rare and fatal genetic disease that impacts the brain, lung, liver, spleen, and other organs. Dr. Reena Sharma, Consultant for Adult Metabolic Medicine and Honorary Senior Lecturer at the Mark Holland Metabolic Unit, is the Principal Investigator for the Salford site, and serves as the Coordinating Investigator for the EU study, which the Company expects will involve additional sites in the UK, Sweden and Italy. The EU clinical study will require 12 patients to be fully enrolled.

To date, intravenous Trappsol® Cyclo™ has been administered to 21 NPC patients worldwide, some for more than six years, via Compassionate Use Programs. Data from treating physicians have demonstrated that multiple patients have shown marked improvements in neurological symptoms, lung function or liver morphology, or had stabilization of disease progression, with no significant safety concerns.

"We are pleased to be participating in this promising clinical trial," said Dr. Sharma. "Based on the compelling compassionate use data generated to date, we believe that Trappsol® Cyclo™ administered intravenously has the potential to effectively treat NPC, for which a significant unmet need exists, with only one approved treatment in Europe and none in the U.S. We look forward to evaluating Trappsol® Cyclo™ in the clinical setting in order confirm these encouraging results."

"The initiation of enrollment in our first clinical site is a significant milestone for the Company in the development of this important treatment for a devastating disease," said CTD Chairman and CEO N. Scott Fine. "We are grateful for the support and encouragement from the many patient families, researchers and clinicians that have worked with us to get to this point."

Trappsol® Cyclo™ is a parenteral grade of hydroxypropyl beta cyclodextrin, a donut-shaped molecule comprised of seven glucopyranose units. Its hydrophilic exterior allows it to move easily through the body, and its inner hydrophobic cavity allows it to capture and hold certain types of molecules, including cholesterol. In NPC patients, cholesterol accumulates abnormally in the body cells.

"NPC is a systemic disease, which is why we are administering Trappsol® Cyclo™ intravenously in this study," said Dr. Sharon Hrynkow, CTD's Senior Vice President for Medical Affairs. "We look forward to working with our colleagues, first in Salford, and then in the additional planned sites, as we enroll patients to move this promising drug candidate forward in this Phase I/II study."

In addition to the EU study, CTD Holdings intends to initiate a Phase I clinical trial shortly in the U.S. evaluating intravenous administration of Trappsol® Cyclo™ in NPC patients.

The Company previously received Orphan Drug designation for the use of Trappsol® Cyclo™ in NPC from the U.S. Food and Drug Administration and the European Medicines Agency.

For further information on this trial and the companion U.S. trial, please visit:

www.ClinicalTrials.gov, or

send email to Dr. Sharon Hrynkow: Sharon.Hrynkow@cyclodex.com.

For patients interested in learning more about the Salford-based trial, please email:

Dr. Reena Sharma: Reena.Sharma@srft.nhs.uk, or

Ms. Ezi Otti: ezi.otti@aptusclinical.com.

For press inquiries contact:

Hans Vitzthum: Hans@lifesciadvisors.com

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.

Contact Information