HIGH SPRINGS, FL--(Marketwire - June 01, 2010) -
CTD Holdings, Inc. (OTCBB: CTDH
) (FRANKFURT: CDJ) today confirmed that CTD's, Trappsol® Cyclo™, has been awarded orphan drug status for the treatment of Niemann Pick Type C (NPC) disease by the U.S. FDA in a letter received by Dr. Caroline Hastings of the Children's Hospital Oakland Research Institute (CHORI). Dr. Hastings and Chris Hempel have used CTD's technical input very effectively with the FDA to, first, craft the compassionate use approval almost two years ago, and now, achieve the awarding of orphan drug status to Trappsol® Cyclo™.
The company is pressing ahead with completing the cGMP production facility under construction at its headquarters in High Springs, Florida. This facility, centered on Pulse Drying technology, will be capable of producing 10's to 1000's of kilogram quantities of Trappsol® Cyclo™ and pharmaceutical grade complexes of its Trappsol® cyclodextrins with other active pharmaceutical ingredients (API's).
"It is important," stated CTD Chairman & CEO Rick Strattan, "that we convey to our shareholders, how the company plans to use its Pulse Drying capabilities to increase the availability of ameliorative therapies like Cyclo™ and other new and existing API's."
"We will do our best to keep our shareholders apprised as each piece falls into place," finished Mr. Strattan.
About Niemann Pick Type C diseases
NPC disease is one of at least 42 rare, fatal diseases, which are classed as lysosomal storage diseases (LSD). The disease is characterized by cellular accumulation of lipids, in particular, unesterified cholesterol and glycosphingolipids, in most cells of the body including brain, liver and spleen. Treatment with Cyclo™ has been shown to delay clinical disease onset, to reduce intraneuronal storage, secondary markers of neurodegeneration, and significantly increase in lifespan in NPC mice and cats in recent clinical studies.
About CTD Holdings, Inc.
CTD Holdings, Inc. is a one-stop shop, business-to-business facilitator of commercial and research applications of Cyclodextrins. With its branded Trappsol®, Aquaplex® and Cyclo™ product offerings, CTDH scientists coordinate the development of commercial products for use in many diverse industries that endeavor to put non water-soluble ingredients into water-based formulations for direct use or conversion into stable, easy to use powders.
This news release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements. CTDH is timely in the filing of its SEC mandated financial reports; these filings also contain forward-looking statements. The above forward-looking statements are made as of the date above; CTD Holdings, Inc accepts no specific responsibility for updating such statements.