For families interested in knowing more, contact:
Dr. Caroline Hastings at Children's Hospital Oakland: email@example.com
Dr. Caroline Hastings, a pediatric hematologist/oncologist at UCSF Benioff Children’s Hospital Oakland, discusses her role in treating the first Niemann-Pick Disease Type C (NPC) patients in the U.S. with Trappsol® Cyclo™ and how this grew to a global compassionate-use program for NPC patients, then formal clinical trials at CTD. Dr. Hastings is the Principal Investigator on CTD’s phase I clinical trial, Senior Clinical Advisor on CTD’s phase I/II clinical trial in Europe, and she co-chairs CTD’s Family and Physicians Listening Circle.
Trappsol® Cyclo™ is an experimental treatment for people with Niemann-Pick Disease Type C. It is a proprietary formulation of a ring of sugar molecules known as cyclodextrins. CTD uses hydroxypropyl beta cyclodextrin in its formulation of Trappsol® Cyclo™. Laboratory experiments have shown that Trappsol® Cyclo™ can remove the harmful cholesterol build up from animal cells, and it has been used by NPC patients on a compassionate basis for up to 7 years.
Dr. Benny Liu, a gastroenterologist at Highland Hospital and UCSF Benioff Children’s Hospital, Oakland, California, discusses his groundbreaking research on cyclodextrins as a treatment of Niemann-Pick Disease Type C (NPC), a rare and fatal genetic disease that impacts the brain, lung, liver, spleen, and other organs. Dr. Liu is a member of CTD’s Scientific Advisory Board and a co-Investigator on CTD’s phase I clinical trial using Trappsol® Cyclo™, CTD’s proprietary orphan drug for treatment of NPC.
N. Scott Fine, Chairman and CEO of CTD Holdings, discusses CTD’s evolution from a fine chemicals company to a clinical-stage pharmaceutical company that develops cyclodextrins to treat human disease, particularly the orphan drug Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C, a rare and fatal genetic disease that impacts the brain, lung, liver, spleen, and other organs.
ALACHUA, FL -- (Marketwired) -- 04/30/18 -- CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, today announced that FDA has authorized its application for "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)" to proceed and states there are no safety concerns.
"The study will allow CTD's Trappsol® Cyclo™ to be administered to eligible patients who have completed CTD's Phase I study to evaluate single and multiple dose pharmacokinetics of intravenously administered Trappsol® Cyclo™", said N. Scott Fine, Chairman and CEO, CTD Holdings, Inc. "Continued access to our drug through this extension study will allow us to further evaluate the long-term benefits and safety of Trappsol® Cyclo™ in those suffering from NPC. As our company works toward market registration of Trappsol® Cyclo™, this study is expected to provided key insights."
The Extension Study will be led by Dr. Caroline Hastings, pediatric hematologist/oncologist at UCSF's Benioff Children's Hospital Oakland, California. Dr. Hastings is also the Principal Investigator for the Phase I trial.
"Trial participants who have received Trappsol® Cyclo™ and who meet eligibility requirements will be afforded an important opportunity to continue receiving the drug," said Dr. Hastings. "The decision by CTD to support an extension protocol while formal trials for market registration are still ongoing shows an enormous commitment from the company."
CTD's proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™ is currently being evaluated in the Phase I study centered in the US, as well as in a Phase I/II study centered in the UK, Sweden and Israel. NPC is a rare genetic disease that causes neurologic, liver, lung and other organ dysfunction and that is ultimately fatal.
"CTD's commitment to the NPC community is clear. With this extension study, we expand our clinical program as we work to find new treatment options for this rare and devastating disease," said Sharon Hrynkow, PhD, CTD's Senior Vice President for Medical Affairs.
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 and is the subject of two ongoing 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
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Source: CTD Holdings, Inc.