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CTD Holdings' Clinical Program to Move Forward in the U.S.

Monday, February 29, 2016   (0 Comments)
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CTD Holdings' Clinical Program to Move Forward in the U.S.

Following a Productive Meeting With FDA, Company Plans to File an IND Application for Trappsol(R) Cyclo(TM) to Treat NPC Disease

ALACHUA, FL -- (Marketwired) -- 02/29/16 -- CTD Holdings, Inc. (OTCQB: CTDH), a biotechnology company that develops cyclodextrin-based products for the treatment of disease, has received responses from the U.S. Food and Drug Administration to its proposed clinical program for investigating the use of its Trappsol® Cyclo™ drug candidate to treat Niemann-Pick Type C (NPC). NPC is a rare and fatal cholesterol metabolism disease found primarily in children and young adults. The FDA responses were received as a result of a pre-IND meeting held January 27, 2016.

The FDA has advised CTD that it has sufficient pre-clinical data to support a clinical trial of Trappsol® Cyclo™ in the United States. CTD's clinical study design calls for intravenous administration of Trappsol® Cyclo™. Based on the FDA's responses, CTD is moving forward with its preparation and submission of an IND application in the United States.

"The FDA responses reflect another productive meeting with regulators," said N. Scott Fine, CTD Chairman and CEO. "We now have more momentum for our global clinical program, which we are building to benefit NPC patients, families and CTD stakeholders worldwide. We look forward to submitting our IND application," he added.

Among the experts who joined the pre-IND meeting on behalf of CTD were key consultants Professor Alan Boyd, UK-based pharmaceutical physician and leader in the field; Dr. Caroline Hastings, practicing pediatric oncologist at UCSF Benioff Children's Hospital Oakland and CTD Scientific Advisory Board member; and Dr. Benny Liu, gastroenterologist with the Alameda Health System, Oakland, and CTD Scientific Advisory Board member. Dr. Hastings was the first physician in the United States to use cyclodextrins (in the form of Trappsol® Cyclo™) in the treatment of patients with NPC, and Dr. Liu and colleagues at UT Southwestern were the first to demonstrate cyclodextrin efficacy in an animal model of the disease.

"The elements of CTD's clinical study design discussed with the FDA were drawn largely from protocols using Trappsol® Cyclo™ in compassionate use programs around the world," said Dr. Sharon Hrynkow, CTD's Senior Vice President for Medical Affairs. "We are particularly grateful to the NPC families and physicians from the U.S., Brazil and Spain who shared their data and experiences with us, including those who have been administering Trappsol® Cyclo™ intravenously for more than five years."

About the Company: 
CTD Holdings, Inc. is a 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 the EU, is used to treat Niemann-Pick Type C, a rare and fatal genetic disease. 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.

Contact:
Sitrick And Company
Wendy Tanaka
(415) 369-8447
wtanaka@sitrick.com

Thomas Mulligan
(212) 573-6100, Ext. 395
tmulligan@sitrick.com

Source: CTD Holdings, Inc.


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