ORLANDO, FL / ACCESSWIRE / October 28, 2019 / Cyclo Therapeutics (OTCQB:CTDH), formerly CTD Holdings, is moving forward on the development of an Alzheimer's treatment using its proprietary Trappsol® Cyclo™ after reporting successful results from its first year of dosing of the drug in an Alzheimer's patient.
FDA authorization for a single patient IND expanded access program for Trappsol® Cyclo™, the company's proprietary formulation of hydroxypropyl beta cyclodextrin, was received for the treatment of late-onset Alzheimer's Disease in March 2018.
The IND was submitted by Diana Kerwin, MD, of the Kerwin Research Center. Dr. Kerwin is a recognized expert in Alzheimer's disease and memory disorders who was previously part of the Northwestern University, National Institute on Aging-funded, Cognitive Neurology and Alzheimer's Disease Center, where she oversaw clinical trials and clinical research for the development of treatments for Alzheimer's Disease. In a collaborative agreement with Dr. Kerwin, all development rights for the drug belong to CTDH.
The expanded access program has been funded externally, with CTDH providing key materials, expertise, and support, in addition to the drug itself.
The company announced its first annual report with the FDA related to the program in June 2019. The one-year report described a favorable safety profile as well as encouraging initial observations on potential benefit.
"The report suggests cognitive and neurologic stability, indicating possible benefit," said Sharon Hrynkow PhD, CTDH's Chief Scientific Officer and Senior Vice President for Medical Affairs.
Commenting on the report, N. Scott Fine, CTDH's Chairman and CEO, added, "The data suggest a positive safety profile in this patient, overall stabilization of disease, and improvement in certain behavioral aspects of the disease."
Given that persons with late-onset Alzheimer's Disease are generally expected to decline during a one-year timeframe, the results with this patient are extremely promising.
Based on data from this case, the company's Scientific Advisory Board formally endorsed plans to move forward with the launch of a clinical trial in Alzheimer's.
Alzheimer's is Currently the Most Common Form of Dementia
According to the Alzheimer's Association, 5.8 million Americans are living with Alzheimer's Disease. By 2050, this number is projected to rise to nearly 14 million.
It's estimated that Alzheimer's and other dementias cost the US $290 billion annually. These costs could rise as high as $1.1 trillion by 2050.
Despite its prevalence, after more than 30 years of research, there is still no cure for Alzheimer's, and only a handful of medications have reached the market.
World-Leading Researcher in Alzheimer's and Neurodegenerative Diseases Joins Advisory Board
Earlier this year, M. Flint Beal, MD, University Professor of Neurology and Neuroscience in the Department of Neurology and Neuroscience at the Weill Medical College of Cornell University - New York Presbyterian Hospital, joined the company's scientific advisory board.
Dr. Beal was a co-author of a study showing that hydroxypropyl beta cyclodextrins, when provided subcutaneously in a mouse model of Alzheimer's, can improve memory of the mouse and decrease amyloid beta plaques (the hallmark of Alzheimer's) in the mouse brain.
"Dr. Beal's addition to the Scientific Advisory Board is an important milestone as CTDH works to identify new drug development targets and strategies," said Fine.
Dr. Beal received his medical degree from the University of Virginia in 1976 and did his residency in Neurology at The Massachusetts General Hospital. Dr. Beal was Professor of Neurology at the Harvard Medical School and Massachusetts General Hospital before moving to Weill Cornell as Chairman of Neurology and Neuroscience. Dr. Beal's research has focused on the mechanisms of neuronal degeneration in neurodegenerative diseases.
Author or co-author of more than 500 scientific articles and more than 125 books, book chapters, and reviews, Dr. Beal serves on the editorial boards of nine journals and is Associate Editor of Annals of Clinical and Translational Neurology.
New Collaboration to Advance Alzheimer's Disease Study
In September, CTDH announced a collaboration with the Chattanooga Center for Neurologic Research (CCNR) based in Chattanooga, Tennessee.
CCNR is a biomedical research company led by globally recognized vascular neurologist Thomas G. Devlin, MD, PhD. In close partnership with Erlanger Health System and the University of Tennessee College of Medicine, Dr. Devlin has spearheaded the launch of various biotechnology companies whose commercialized products are having widespread impact on neurologic disease.
The collaboration is expected to lead to the selection of CCNR and the Erlanger Health System as a site in CTDH's clinical trial in Alzheimer's Disease, now in the design stage.
"Given the significant overlap between stroke, dementia, and Alzheimer's disease, we are delighted to undertake this collaboration with Dr. Devlin and his team as we build our respective Alzheimer's programs," said Fine. "Dr. Devlin's expertise as a world-class clinical researcher in neurovascular disease and stroke is directly applicable as we build out the CTDH Alzheimer's platform."
Dr. Devlin added, "With Tennessee having the second highest death rate from Alzheimer's disease of any state in the United States, we are now totally committed to continuing to identify visionary and innovative industry partners to align with as we launch our next major research initiative - Alzheimer's disease. CTD Holdings is the perfect partner and I anticipate years of close and productive collaboration in our quest to cure Alzheimer's."
Low Valuation Relative to Potential Upside
With a $1B+ annual addressable market in Alzheimer's disease, CTDH offers a compelling opportunity for potential upside from its current valuation.
The company has a strong management team and board, with senior leadership experience built at major companies in life sciences and beyond, including Polpharma, Pfizer, Sanofi, USP Zdrowie, Colgate-Palmolive, and Green Mountain Coffee.
Insiders have invested approximately $10 million to date, and with an institutional round of $7.4 million in equity financing closed in 2019, CTDH has a strong balance sheet to move its programs forward.
Despite these and many other strengths, including CTDH's Phase I/II trials for a rare genetic disease called Niemann-Pick Disease Type C (NPC), representing a $500 million addressable market, the company's stock trades for a market cap of under $25 million. As the company continues to achieve major milestones and more investors learn of the opportunity, shares could begin moving toward a more realistic and higher valuation.
Buy Recommendation from High Net-Worth Investor Journal
The September 30 edition of Frazier, Browne and Mayer's Strategic Allocator, a monthly research and advisory journal for RIAs and high net-worth individuals, gave CTDH a buy recommendation.
In recommending CTDH shares, Strategic Allocator cited the company's upcoming Phase III trial of its treatment for NPC and the potential for the same drug, Trappsol® Cyclo™, to be used effectively in treating Alzheimer's Disease.
This is the first OTC stock Strategic Allocator has recommended its readers buy, according to publisher David Frazier.
Learn more about CTDH, its work in Alzheimer's, and its clinical trials for NPC, by visiting CTDHinfo.com, where you can sign up for free news alerts to stay abreast of the latest developments of this exciting opportunity.
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