Posted by CTD Holdings, a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, 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.
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.”
Physicians seeking more information on CTD’s clinical programs should contact:
Sharon H. Hrynkow, PhD, CTD Senior Vice President for Medical Affairs at sharon.hrynkow@cyclodex.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 chastings@mail.cho.org or,
Allen Hodgson, Oakland Study Coordinator at ahodgson@mail.cho.org or,
Dr. Darius Adams at darius.adams@atlantichealth.org or,
Christina Flora, Morristown Study Coordinator at christina.flora@atlantichealth.org.