CTD Holdings' European Clinical Trial Adopted by National Institute for Health Research of England
2018-01-16
Collaboration Will Provide Infrastructure Support to Study
ALACHUA, FL -- (Marketwired) -- 01/16/18 -- 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's Phase I/II Clinical
Trial "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) has been
adopted by the National Institute for Health Research's Clinical
Research Network (CRN) of England. The CRN makes it possible for
patients and health professionals across England to participate in
clinical research studies throughout the National Health Service
(NHS).
"We are excited and proud to be included in the work of the CRN as it
advances clinical trials to benefit patients in England," said CTD
Chairman and CEO N. Scott Fine. "CRN support is another means through
which we can complete our study swiftly."
CRN meets the costs of NHS staff that support research; provides
specialist training so that patients can be confident that research
is being delivered by experienced front-line staff; meets the costs
of using NHS facilities and equipment needed in the course of
studies; and, provides practical help in identifying and recruiting
patients however needed.
CTD supports two sites in England: Salford Royal Foundation NHS Trust
under the leadership of Dr. Reena Sharma, and University College
London Hospitals NHS Foundation Trust under the leadership of Dr.
Robin Lachmann.
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. 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.
Investor/Media Contact:
Sitrick and Company
Wendy Tanaka
(415) 369-8447
wtanaka@sitrick.com
Thomas Mulligan
(212) 573-6100, Ext. 395
tmulligan@sitrick.com
