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CTD Announces Partnership with Synteract to support the Extension Protocol for its Phase I Clinical Trial in the United StatesALACHUA, Fla., Nov. 08, 2018 (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, Synteract. Synteract is a full-service Clinical Research Organization which has an existing relationship with CTD in support of its Phase I/II clinical trial at sites in Israel and Sweden. Synteract 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. “Synteract is a world-class company with broad expertise in the management and conduct of clinical trials,” said N. Scott Fine, CTD’s Chairman and CEO. “Their skills will bolster our ability to continue to provide Trappsol® Cyclo™ to individuals suffering from NPC after they complete our US Phase 1 trial. We are deeply committed to the NPC families and the NPC community.” CTD’s Extension Protocol for the Phase I trial was approved by FDA in April 2018. The Protocol allows for 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. Participants will be permitted to receive intravenous dosing in the home setting or in the hospital setting. 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. “Synteract is now a critical part of CTD’s overall clinical program in the United States,” said Sharon H. Hrynkow, PhD, CTD’s Senior Vice President for Medical Affairs. “As we continue to advance our formal clinical trials, the information gathered via this extension protocol will be useful to the FDA and to regulatory authorities in Europe and Israel as we seek market registration for Trappsol® Cyclo™.” More information on CTD’s Phase I trial is available in a video recording of a webinar held October 16, 2018 and available at 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 US, United Kingdom, Sweden and Israel. About CTD Holdings: About Synteract: Safe Harbor Statement: Investor/Media Contact: Thomas Mulligan |