International Niemann–Pick Disease Alliance
Initial data support safety and tolerability of Trappsol® Cyclo™ administered intravenously
(Available for download, here)
ALACHUA, FL – (Marketwired) – 03/29/2018 – CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, announced today that the company has completed an initial review of safety data for its ongoing trials, “A Phase I Study to Evaluate the Single and Multiple-dose Pharmacokinetics of Intravenous Trappsol® Cyclo™ (HPBCD) in Patients with Niemann-Pick Disease Type C (NPC-1) and the Effects of Dosing upon Biomarkers of NPC Disease”, (NCT 02939547) and, “A Phase I/II Study to Evaluate the Safety and pK of IV Trappsol® Cyclo™ (HPBCD) in Patients with Niemann-Pick Disease Type C (NPC-1) and the Pharmacodynamic Effects of Treatment upon Markers of Cholesterol Metabolism and Clinical Outcomes” (NCT02912793). Both trials use CTD’s proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™.
Both Safety Review Committees (SRCs) are Chaired by Professor Alan Boyd MD, currently the President of the Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians of the United Kingdom, as well as Founder and CEO of Boyd Consulting. “The data reviewed by both Committees to this point show that patients tolerate Trappsol® Cyclo™ well, and that Trappsol® Cyclo™ continues to have a favourable benefit:safety profile in this patient population,” said Professor Boyd, on behalf of both Safety Review Committees.
Other members of the phase I/II SRC are Dr. Caroline Hastings, pediatric hematologist/oncologist, UCSF Benioff Children’s Hospital Oakland (also Co-Chair, and Principal Investigator of the Phase I clinical trial) and Medical Monitor Dr. Bryan Murray. Dr. Hastings is the first physician in the US to administer hydroxypropyl beta cyclodextrins (CTD’s Trappsol® Cyclo™) to NPC patients, and she has the longest standing experience of any physician globally in administering beta cyclodextrins intravenously in this patient population. The Phase I SRC includes Dr. Reena Sharma, metabolic disease expert, Salford Royal Foundation Trust, National Health Service, UK (also Coordinating Principal Investigator for the Phase I/II Trial and Site Director in that same study) and Dr. Murray. The phase I trial has a single site in the US, while the phase I/II has sites in the UK, Sweden, Italy and Israel.
“Patient safety is paramount in any clinical trial. The initial data and findings of the four physicians on our SRCs are consistent with those that we have seen from use of Trappsol® Cyclo™ intravenously in our compassionate use program, now in its 8th year in Brazil and 5th year in several European countries.” said N. Scott Fine, CTD Chairman and CEO, “We look forward to sharing additional information with the NPC community on our trials in the coming months.”
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 formal clinical trials (two clinical trials for this indication are currently open 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.
Sitrick and Company
(212) 573-6100, Ext. 395