{"id":408420,"date":"2021-01-05T08:03:40","date_gmt":"2021-01-05T13:03:40","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=408420"},"modified":"2021-01-05T08:03:40","modified_gmt":"2021-01-05T13:03:40","slug":"cyclo-therapeutics-announces-positive-efficacy-data-from-extension-protocol-with-trappsol-cyclo-in-patients-with-niemann-pick-disease-type-c","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-announces-positive-efficacy-data-from-extension-protocol-with-trappsol-cyclo-in-patients-with-niemann-pick-disease-type-c\/","title":{"rendered":"Cyclo Therapeutics Announces Positive Efficacy Data from Extension Protocol with Trappsol\u00ae Cyclo\u2122 in Patients with Niemann-Pick Disease Type C"},"content":{"rendered":"

<\/p>\n

Cyclo Therapeutics Announces Positive Efficacy Data from Extension Protocol with Trappsol\u00ae<\/sup> Cyclo\u2122 in Patients with Niemann-Pick Disease Type C<\/b><\/p>\n

Home-based intravenous infusions of Trappsol\u00ae Cyclo\u2122 for up to one year show improvement in disease features or disease stabilization<\/b><\/p>\n

GAINESVILLE, Fla.–(BUSINESS WIRE<\/a>)–
\nCyclo Therapeutics, Inc. (NasdaqCM:CYTH) (NasdaqCM:CYTHW), a clinical stage biotechnology company developing a cyclodextrin platform for the treatment of neurodegenerative diseases, including its lead candidate Trappsol\u00ae<\/sup> Cyclo\u2122 for the treatment of Niemann-Pick Disease Type C (NPC), today announced initial data from its \u201cOpen-Label Study of Long-Term Safety and Efficacy of Intravenous Trappsol\u00ae<\/sup> Cyclo\u2122 (HPBCD) in Niemann-Pick Disease Type C,\u201d NCT03893071<\/a>. Eight patients living in the US who completed the Phase I trial (NCT02939547<\/a>) were eligible for the extension program. All eight enrolled.\n<\/p>\n

\nThe first patient was dosed in the Open-Label extension study in May 2019 and the last patient enrolled was in February 2020. The initial efficacy results presented below have a data cut-off of September 2020.\n<\/p>\n

\nAll patients included in this analysis demonstrated disease stability or improvement as measured by the 17-domain NPC Severity Score scale (NPC-SS, Yanjinin et al, 2010). The NPC-SS measures primarily neurologic features of the disease, including ambulation, fine motor skills, ability to speak and swallow, and cognition. Without intervention, over the course of one year, NPC patients would be expected to worsen by one to two points using this scale.\n<\/p>\n

\nDuring this Open-Label Study, patients receive intravenous infusions of Trappsol\u00ae<\/sup> Cyclo\u2122 in their homes under the care of healthcare professionals every two weeks, with regular assessments for NPC-SS at UCSF Benioff Children\u2019s Hospital Oakland under the care of Dr. Caroline Hastings and Dr. Benny Liu, Co-Principal Investigators.\n<\/p>\n

\nOf the patients who received Trappsol\u00ae Cyclo \u2122 at the 1500 mg\/kg body weight dose level, four patients remained stable in terms of their NPC-SS and two patients improved:\n<\/p>\n

\nPatient 1 had a baseline NPC-SS of 24; and the same score 10 months later.\n<\/p>\n

\nPatient 2 had a baseline NPC-SS of 18, with the same score 4 months later and again 6 months after the second assessment.\n<\/p>\n

\nPatient 3 had a baseline NPC-SS of 11 and the same score 7 months later.\n<\/p>\n

\nPatient 4 had a baseline NPC-SS of 12 and the same score 6 months later.\n<\/p>\n

\nPatient 5 had a baseline NPC-SS of 16, a score of 15 five months later (improvement of 1 point), and a score of 13 eight months later (representing improvement by total 3 points).\n<\/p>\n

\nPatient 6 had a baseline NPC-SS of 12 and a score of 10 eight months later (an improvement of 2 points).\n<\/p>\n

\nOf the patients in the 2500 mg\/kg dose group, both improved overall:\n<\/p>\n

\nPatient 7 had a baseline NPC-SS of 18, followed by a score of 20 four months later (a worsening of 2 points) and a score of 15 six months later (a total improvement of 3 points compared to baseline during the 10-month assessment period).\n<\/p>\n

\nAnd, Patient 8 had a baseline NPC-SS of 12 and a score of 8 five months later (an improvement of 4 points).\n<\/p>\n

\n\u201cThese preliminary data provide additional signals of efficacy for our drug as a treatment for NPC, a progressive and debilitating disease often leading to premature death. The fact that patients either stabilized or improved during periods up to one year is consistent with data emerging from our Phase I\/II in Europe and Israel,\u201d said Cyclo Therapeutics CEO and Director, N. Scott Fine. \u201cThese extension protocol data provide additional compelling support for the efficacy of our drug in this patient population, and as we launch our pivotal Phase 3 trial in early 2021.\u201d\n<\/p>\n

\nThe safety profile was favorable with 16 Adverse Events (AEs) in total between May 2019 and September 2020, all mild (Grade 1 and 2) and none related to the study drug, per the treating physician.\n<\/p>\n

\n\u201cNPC is a progressive, devastating disorder without approved therapies in the United States. The overall safety profile of Trappsol\u00ae<\/sup> Cyclo\u2122 is reassuring in that the drug is well tolerated, with adverse events in the mild and moderate range of severity. In addition, the clinical trajectory of the participants suggests stabilization while on therapy. These results offer the exciting promise of an effect on the progression of symptoms in NPC, a notable breakthrough for this condition,\u201d said Loren Pena, MD, PhD, Associate Professor, Department of Pediatrics, University of Cincinnati College of Medicine and Attending Physician, Division of Human Genetics, Cincinnati Children\u2019s Hospital, who is not associated with the study.\n<\/p>\n

\nCyclo Therapeutics has authorization from FDA to begin enrollment in its phase 3 trial and plans to enroll the first patient early in 2021.\n<\/p>\n

About Cyclo Therapeutics:<\/i><\/b><\/p>\n

\nCyclo Therapeutics, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C and Alzheimer\u2019s Disease. The company\u2019s Trappsol\u00ae<\/sup> Cyclo\u2122, an orphan drug designated product in the United States and Europe, is the subject of three ongoing formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, (ClinicalTrials.gov NCT02939547<\/a>, NCT02912793<\/a> and NCT03893071<\/a>). The company is planning an early phase clinical trial using Trappsol\u00ae<\/sup> Cyclo\u2122 intravenously in Alzheimer\u2019s Disease based on encouraging data from an Expanded Access program for late-onset Alzheimer\u2019s Disease (NCT03624842<\/a>). Additional indications for the active ingredient in Trappsol\u00ae<\/sup> Cyclo\u2122 are in development. For additional information, visit the company\u2019s website: www.cyclotherapeutics.com<\/a><\/p>\n

Safe Harbor Statement:<\/i><\/b><\/p>\n

\nThis press release contains \u201cforward-looking statements\u201d about the company\u2019s current expectations about future results, performance, prospects and opportunities, including, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering. Statements that are not historical facts, such as \u201canticipates,\u201d \u201cbelieves\u201d and \u201cexpects\u201d 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\u2019s future performance include the company\u2019s 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\u2019s 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\u2019s filings with the Securities and Exchange Commission, including, but not limited to, the company\u2019s 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.\n<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210105005179\/en\/<\/a><\/span><\/p>\n

Investor\/Media Contact:
\n<\/i><\/b>
Jeffrey L. Tate, Ph.D., COO
\n
Cyclo Therapeutics, Inc.
\n
jeff@cyclodex.com
\n<\/a>
+1 (386) 418-8060\n<\/p>\n

KEYWORDS:<\/b> United States North America Florida<\/p>\n

INDUSTRY KEYWORDS:<\/b> Science Biotechnology Research Pharmaceutical Health FDA Genetics Clinical Trials<\/p>\n

MEDIA:<\/b><\/p>\n\n","protected":false},"excerpt":{"rendered":"

Cyclo Therapeutics Announces Positive Efficacy Data from Extension Protocol with Trappsol\u00ae Cyclo\u2122 in Patients with Niemann-Pick Disease Type C Home-based intravenous infusions of Trappsol\u00ae Cyclo\u2122 for up to one year show improvement in disease features or disease stabilization GAINESVILLE, Fla.–(BUSINESS WIRE)– Cyclo Therapeutics, Inc. (NasdaqCM:CYTH) (NasdaqCM:CYTHW), a clinical stage biotechnology company developing a cyclodextrin platform for the treatment of neurodegenerative diseases, including its lead candidate Trappsol\u00ae Cyclo\u2122 for the treatment of Niemann-Pick Disease Type C (NPC), today announced initial data from its \u201cOpen-Label Study of Long-Term Safety and Efficacy of Intravenous Trappsol\u00ae Cyclo\u2122 (HPBCD) in Niemann-Pick Disease Type C,\u201d NCT03893071. Eight patients living in the US who completed the Phase I trial (NCT02939547) were eligible for the extension program. All … <\/p>\n

Continue reading “Cyclo Therapeutics Announces Positive Efficacy Data from Extension Protocol with Trappsol\u00ae Cyclo\u2122 in Patients with Niemann-Pick Disease Type C”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-408420","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nCyclo Therapeutics Announces Positive Efficacy Data from Extension Protocol with Trappsol\u00ae Cyclo\u2122 in Patients with Niemann-Pick Disease Type C - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-announces-positive-efficacy-data-from-extension-protocol-with-trappsol-cyclo-in-patients-with-niemann-pick-disease-type-c\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cyclo Therapeutics Announces Positive Efficacy Data from Extension Protocol with Trappsol\u00ae Cyclo\u2122 in Patients with Niemann-Pick Disease Type C - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Cyclo Therapeutics Announces Positive Efficacy Data from Extension Protocol with Trappsol\u00ae Cyclo\u2122 in Patients with Niemann-Pick Disease Type C Home-based intravenous infusions of Trappsol\u00ae Cyclo\u2122 for up to one year show improvement in disease features or disease stabilization GAINESVILLE, Fla.–(BUSINESS WIRE)– Cyclo Therapeutics, Inc. (NasdaqCM:CYTH) (NasdaqCM:CYTHW), a clinical stage biotechnology company developing a cyclodextrin platform for the treatment of neurodegenerative diseases, including its lead candidate Trappsol\u00ae Cyclo\u2122 for the treatment of Niemann-Pick Disease Type C (NPC), today announced initial data from its \u201cOpen-Label Study of Long-Term Safety and Efficacy of Intravenous Trappsol\u00ae Cyclo\u2122 (HPBCD) in Niemann-Pick Disease Type C,\u201d NCT03893071. Eight patients living in the US who completed the Phase I trial (NCT02939547) were eligible for the extension program. 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(NasdaqCM:CYTH) (NasdaqCM:CYTHW), a clinical stage biotechnology company developing a cyclodextrin platform for the treatment of neurodegenerative diseases, including its lead candidate Trappsol\u00ae Cyclo\u2122 for the treatment of Niemann-Pick Disease Type C (NPC), today announced initial data from its \u201cOpen-Label Study of Long-Term Safety and Efficacy of Intravenous Trappsol\u00ae Cyclo\u2122 (HPBCD) in Niemann-Pick Disease Type C,\u201d NCT03893071. Eight patients living in the US who completed the Phase I trial (NCT02939547) were eligible for the extension program. 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