International Niemann–Pick Disease Alliance
CTD is also a proud sponsor of the conference, for the 4th year running…
ALACHUA, FL–(Businesswire)–11 September 2019–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 the company will present on its clinical and drug development program for the orphan drug, Trappsol(R) Cyclo(TM), at the Niemann-Pick UK (NPUK) 10th Interactive Workshop on Niemann-Pick Diseases and the 26th Annual NPUK Family Conference. The conference brings together patients, families, caregivers, scientists, and health professionals for the purposes of learning about advances in NPC clinical trials and providing opportunities for community learning, sharing and support. The conference will take place at the Wyboston Conference Centre, Bedfordshire, UK from September 19 to 22.
As it has for the past 4 years, CTD also provided an unrestricted grant to the NPUK to assist in support of all conference related activities.
Niemann-Pick type C Disease (NPC) is a rare and fatal genetic disease affecting 1 in 100,000 live births globally. NPC affects every cell in the body due to the defect in the NPC protein which is responsible for cholesterol processing in the cell. Because of the NPC defect in this disease, cholesterol accumulates abnormally in every cell in the body, causing symptoms in the brain, liver, spleen, lung and other organs.
CTD’s presentations at the conference will include data from its Phase I safety and tolerability trial based in the United States utilizing intravenous administration of Trappsol(R) Cyclo(TM), its proprietary formulation of hydroxypropyl beta cyclodextrin, for the treatment of NPC (NCT02939547) and from its Phase I/II safety and efficacy trial based in the UK, Sweden, Israel and Italy using the same drug and also with intravenous administration (NCT02912793) . Both trials are in the final stage of recruiting patients. An extension trial for the Phase I US-based trial is underway (NCT03893071) : the extension trial allows for home-based infusions by skilled health care professionals.
The presentations will be made by Sharon H. Hrynkow, PhD, CTD’s Chief Scientific Officer and Senior Vice President for Medical Affairs and Reena Sharma, MD, Consultant in Inherited Adult Inherited Metabolic Disorders, Mark Holland Metabolic Unit, Salford Royal Hospital NHS Foundation Trust, Salford, UK. Dr. Sharma is Principal Investigator for CTD’s trial at the Salford site and EU Coordinating Investigator for the Phase I/II trial. CTD will also be represented at the conference by Mr. Michael Lisjak, Global Head of Regulatory Affairs and Senior Vice President for Business Development.
Presentation Details:
NPUK 10th Interactive Workshop on Niemann-Pick Diseases (participants are health professionals and scientists)
Date: Friday, September 20
Title, Presenter: Update on CTD’s Clinical Programs, Dr. Sharon Hrynkow.
NPUK 25th Annual Family Conference (participants are NPC patients and families, with updates on clinical trials provided by health professionals)
Date: Saturday, September 21
Title, Presenter: CTD’s Phase II Intravenous Trial of Trappsol(R) Cyclo(TM) for NP-C, Dr. Reena Sharma.
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 three ongoing formal clinical trials (Clinical Trials.gov NCT02939547, NCT02912793 and NCT03893071). 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:
RedChip Companies, Inc. Victor Roberts 407-571-0909 victor@redchip.com