Cyclo Therapeutics Inc (CYTH)

[Lazarus]

You're right about one thing -- it will be all about patience.

The company announced that they had their first patient for their Phase one test in their European trials in July and the article states they expect results at the end of 2018. I assume that will be for the ONE patient.

Today's article states that "The Phase I clinical trial will require 12 patients to be fully enrolled." So that means they need 11 more.

Patience, Patience, Patience....and many more rounds of financing to come by my calculations.



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CTD Holdings Announces First Patient Dosed in Phase I/II Clinical Trial to Evaluate Trappsol(R) Cyclo(TM) in Niemann-Pick Disease Type C

Jul 19, 2017
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CTD Holdings Announces First Patient Dosed in Phase I/II Clinical Trial to Evaluate Trappsol(R) Cyclo(TM) in Niemann-Pick Disease Type C

Study Evaluating Safety and Efficacy of Trappsol(R) Cyclo(TM) in a Multi-center European Trial

Company Expects Final Data from Trial by End of 2018

ALACHUA, FL--(Marketwired - July 19, 2017) - CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company developing cyclodextrin-based products for the treatment of disease, today announced that the first patient has been dosed intravenously in the Company's European Phase I/II clinical trial evaluating Trappsol® Cyclo™ in patients with Niemann-Pick Disease Type C (NPC), a rare and fatal genetic disease that impacts the brain, lung, liver, spleen, and other organs.

The first patient was dosed by Dr. Reena Sharma and her team at Salford Royal NHS Foundation Trust in the United Kingdom. Dr. Sharma is Consultant for Adult Metabolic Medicine and Honorary Senior Lecturer at the Mark Holland Metabolic Unit of the Salford NHS Trust, and the Coordinating Investigator for the Phase I/II trial of Trappsol® Cyclo™ in Europe. The first patient visit was supported by NIHR Manchester Clinical Research Facility, which provides 24-hour cover for intensive and complex research studies.

"There is currently no treatment available globally for this condition. Those that are available, are limited to delaying the progression of neurological symptoms or providing palliative care to relieve, for example, the gastrointestinal symptoms and seizures," said Dr. Sharma. "We need new treatments that help to address progression of neurological involvement and some of the other problems our patients experience relating to the liver, spleen and lungs. I hope that this study will lead to a new treatment for this devastating condition."

The Phase I/II clinical trial, which will include additional sites in the UK and Sweden and is also expected to be expanded to Italy, requires 12 patients to be fully enrolled. The trial will evaluate the safety and efficacy of Trappsol® Cyclo™ in NPC patients ages two and older. Patients will be randomized into three dose groups of 1500 mg/kg, 2000 mg/kg and 2500 mg/kg of Trappsol® Cyclo™ administered via bi-weekly intravenous injections over a period of 48 weeks.

"Commencement of dosing of the first patient at the Salford clinical site is another significant milestone for the Company in the development of our Trappsol® Cyclo™," said CTD Chairman and CEO, N. Scott Fine. "We expect final data from this important clinical trial by the end of 2018. CTD remains grateful for the continued support from the many patient families, researchers and clinicians, such as Dr. Sharma, who have helped us reach this important milestone."

Trappsol® Cyclo™ is a parenteral grade of hydroxypropyl beta cyclodextrin, a donut-shaped molecule comprised of seven glucopyranose units. To date, intravenous Trappsol® Cyclo™ has been administered to 21 NPC patients worldwide, some for more than six years, via Compassionate Use Programs. Data from treating physicians in the compassionate use program have demonstrated that multiple patients have shown marked improvements in neurological symptoms, lung function or liver morphology, or had stabilization of disease progression, with no significant safety concerns.

In addition to the European study, CTD Holdings has initiated a Phase I clinical trial in the U.S. evaluating intravenous administration of Trappsol® Cyclo™ in NPC patients. CTD previously received Fast Track Designation in the U.S. and Orphan Drug Designation for the use of Trappsol® Cyclo™ in the treatment of NPC from the U.S. Food and Drug Administration and the European Medicines Agency.

About the clinical trials:

For families interested in learning more about CTD's EU trial or the US trial, please contact CTD's Patient Liaisons:

Ms. Jackie Imrie, based in the UK, at [e-mail]
Ms. Shannon Reedy, based in the U.S., at [e-mail]
Dr. Caroline Hastings, Principal Investigator for the US trial and Senior Clinical Advisor to the EU study, at [e-mail] / Phone [phone]
For physicians interested in learning more about the EU trial or the US trial, please contact:

Dr. Sharon Hrynkow, CTD's Senior Vice President for Medical Affairs at [e-mail], or
Dr. Hastings (see contact information above), or
Dr. Sharma at [e-mail] .

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So long as you are willing to hang in there for the long haul and so long as the company can continue to raise sufficient funds to keep the doors open and the tests going ---> YOU HAVE HOPE.