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CTD Holdings Initiates Recruitment for Phase I/II Clinical Study in Europe of Trappsol(R) Cyclo(TM) for Treatment of Niemann-Pick Disease Type C
Initial Patients to be Enrolled at Salford NHS Trust UK
ALACHUA, FL -- (Marketwired) -- 03/21/17 -- 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.
