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CTD Announces Partnership with United BioSource LLC (UBC) to support the Extension Protocol for its Phase I Clinical Trial in the United States
Collaboration will allow patients in Extension Protocol to receive CTD’s drug intravenously at home
ALACHUA, Fla., Jan. 18, 2019 (GLOBE NEWSWIRE) -- CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, today announced its newest partner in support of its US clinical program, United BioSource LLC (UBC). UBC provides pharmaceutical and home nursing services in support of clinical trials and other patient-centered initiatives. UBC will support CTD’s Extension Protocol, “An Open-Label Extension Study of the Long-Term Safety and Efficacy of Intravenous Trappsol® Cyclo™ (HPBCD) in Patients with Niemann-Pick Disease Type C (NPC-1),” in the United States.
“UBC has a long and distinguished record of providing management of home nursing services in the US and internationally,” said N. Scott Fine, CTD’s Chairman and CEO. “As we work to provide NPC patients in this Extension Protocol with as much support as possible while we continue to work toward market registration of Trappsol® Cyclo™, we believe that it is vital to include an option for infusions at home and under the care of a qualified health care professional. Our partnership with UBC allows us to offer patients this choice.”
CTD’s Extension Protocol for the Phase I trial was approved by FDA in April 2018. The Protocol allows eligible subjects who have completed the Phase I trial in the US to continue to receive intravenous administration of CTD’s Trappsol® Cyclo™, the company’s proprietary formulation of hydroxypropyl beta cyclodextrin, until market registration. The two clinical sites now participating the Phase I trial are also expected to participate in the Extension protocol: UCSF Children’s Hospital Oakland, led by Caroline Hastings, MD, and Morristown Medical Center of the Atlantic Health System, led by Darius Adams, MD.
“Having the option for home infusions is a game changer for many NPC patients,” said Dr. Hastings, who is also the first physician in the United States to administer hydroxypropyl beta cylodextrins to NPC patients. Those first administrations were in 2009 with CTD’s hydroxypropyl beta cyclodextrin product using an intravenous route of administration. “Since intravenous is a relatively low-risk route of administration compared to other routes of administration, it is entirely feasible to administer the drug in a home setting by a qualified healthcare provider.”
More information on CTD’s Phase I trial is available in a video recording of a webinar held October 16, 2018, go the company website: www.ctd-holdings.com. On October 3, 2018 CTD published a press release, HERE, outlining top-line data from both of its intravenous Trappsol® Cyclo™ clinical trials now underway in the U.S., United Kingdom, Sweden and Israel.
Physicians seeking more information on CTD’s clinical programs should contact:
Sharon H. Hrynkow, PhD, CTD Senior Vice President for Medical Affairs at email@example.com.
Families interested in CTD’s phase I trial in the United States should contact:
Shannon Reedy, CTD Family Liaison at Shannon.Reedy@hotmail.com,
Dr. Caroline Hastings at firstname.lastname@example.org or,
Allen Hodgson, Oakland Study Coordinator at email@example.com or,
Dr. Darius Adams at firstname.lastname@example.org or,
Christina Flora, Morristown Study Coordinator at email@example.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, on a compassionate use basis as well as in two ongoing formal clinical trials (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.
United BioSource (UBC) is a leader in the market for integrated, comprehensive clinical, safety, and commercialization services. UBC brings together renowned scientific research and operations experts with leading-edge technologies, allowing for the best patient and healthcare provider experience. Comprehensive, end-to-end services cover product and patient population characterization during development and market entry, as well as a focus on the patient experience, safety, and adherence. For additional information, visit the company’s website: www.ubc.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.
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