{"id":518116,"date":"2021-07-27T08:08:09","date_gmt":"2021-07-27T12:08:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/"},"modified":"2021-07-27T08:08:09","modified_gmt":"2021-07-27T12:08:09","slug":"cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/","title":{"rendered":"Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122"},"content":{"rendered":"

<\/p>\n

Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae<\/sup> Cyclo\u2122<\/b><\/p>\n

GAINESVILLE, Fla.–(BUSINESS WIRE<\/a>)–Cyclo Therapeutics, Inc.<\/a> (Nasdaq: CYTH) (\u201cCyclo Therapeutics\u201d or the \u201cCompany\u201d), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced that it has commenced the commercial-scale production of batches of Trappsol\u00ae<\/sup> Cyclo\u2122, the Company\u2019s proprietary formulation of hydroxypropyl beta cyclodextrin.\n<\/p>\n

\n\u201cCyclo Therapeutics\u2019 robust, scalable and validated manufacturing process has been a cornerstone of our capabilities and enables us to move forward with all of our patient treatment programs,\u201d said Jeffrey L. Tate, Ph.D., Chief Operating Officer and Chief Quality Officer of Cyclo Therapeutics. \u201cThe production of our first commercial-scale cGMP batches of Trappsol\u00ae<\/sup> Cyclo\u2122 allows us to execute on the necessary Chemistry and Manufacturing Controls (CMC) section required by the FDA, and other regulatory authorities, for potential approval and commercialization. Additionally, the resulting drug product inventory will be used to support TransportNPC\u2122, our ongoing pivotal Phase 3 study in Niemann-Pick Disease Type C1, an upcoming Phase 2 study for our Alzheimer\u2019s disease asset, and our active compassionate use program.\u201d\n<\/p>\n

\nTrappsol\u00ae<\/sup> Cyclo\u2122 is a proprietary formulation of hydroxypropyl beta cyclodextrin and has an affinity for cholesterol. In multiple clinical studies, Trappsol\u00ae<\/sup> Cyclo\u2122 has shown encouraging results to effectively manage the transportation of cholesterol. Unlike other clinical programs with hydroxypropyl beta cyclodextrin, the TransportNPC\u2122 trial uses an intravenous route of administration that supports the ability of the drug to reach major peripheral organs, clear cholesterol from cells peripherally and centrally, effectively target a range of CNS biomarkers and underpin neurologic outcomes as demonstrated in the Company\u2019s current data from its completed and ongoing studies.\n<\/p>\n

\n\u201cI am incredibly proud of our team and the tremendous effort to advance Cyclo Therapeutics to this stage of commercial-scale manufacturing for Trappsol\u00ae<\/sup> Cyclo\u2122. This milestone brings us one step closer to our ultimate goal of providing patients, families and caregivers with hope and a potential treatment option for two diseases with significant unmet need,\u201d added N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics.\n<\/p>\n

\nTrappsol\u00ae<\/sup> Cyclo\u2122 is currently being evaluated in the TransportNPC\u2122 study for the treatment of Niemann-Pick Disease Type C1 (\u201cNPC1\u201d), a rare, progressive and fatal genetic disorder. As previously announced, Cyclo Therapeutics received Orphan Drug Designation for Trappsol\u00ae<\/sup> Cyclo\u2122 to treat NPC1 in both the US and EU and Fast Track and Rare Pediatric Disease Designations in the US. The Rare Pediatric Disease Designation is one of the chief requirements for sponsors to receive a Priority Review Voucher in the US upon marketing authorization.\n<\/p>\n

\nCyclo Therapeutics is also planning to evaluate Trappsol\u00ae<\/sup> Cyclo\u2122 for the treatment of Alzheimer\u2019s disease, targeting the reduction of amyloid beta and tau. Following a Type B interaction with the FDA, Cyclo Therapeutics received positive feedback supporting the Company\u2019s development strategy to submit an Initial New Drug (IND) application for a Phase 2 study of intravenous Trappsol\u00ae<\/sup> Cyclo\u2122 in the treatment of early Alzheimer\u2019s disease. The Company is on track to file its IND for a Phase 2 study of Alzheimer\u2019s disease in the second half of 2021.\n<\/p>\n

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

\nCyclo Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from 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, (www.ClinicalTrials.gov<\/a>NCT02939547<\/a>, NCT02912793<\/a>, NCT03893071<\/a> and NCT04860960<\/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>.\n<\/p>\n

Safe Harbor Statement<\/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\/20210727005149\/en\/<\/a><\/span><\/p>\n

Investor Contact:
\n<\/b>
JTC Team, LLC
\n
Jenene Thomas
\n
(833) 475-8247
\n
CYTH@jtcir.com<\/a><\/p>\n

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

INDUSTRY KEYWORDS:<\/b> Research Pharmaceutical Oncology Consumer Infectious Diseases Genetics Children Clinical Trials Science Biotechnology FDA Health<\/p>\n

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

Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122 GAINESVILLE, Fla.–(BUSINESS WIRE)–Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (\u201cCyclo Therapeutics\u201d or the \u201cCompany\u201d), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced that it has commenced the commercial-scale production of batches of Trappsol\u00ae Cyclo\u2122, the Company\u2019s proprietary formulation of hydroxypropyl beta cyclodextrin. \u201cCyclo Therapeutics\u2019 robust, scalable and validated manufacturing process has been a cornerstone of our capabilities and enables us to move forward with all of our patient treatment programs,\u201d said Jeffrey L. Tate, Ph.D., Chief Operating Officer and Chief Quality Officer of Cyclo Therapeutics. \u201cThe production of our first commercial-scale cGMP batches of Trappsol\u00ae Cyclo\u2122 allows us to … <\/p>\n

Continue reading “Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122”<\/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-518116","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nCyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122 - 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-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122 GAINESVILLE, Fla.–(BUSINESS WIRE)–Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (\u201cCyclo Therapeutics\u201d or the \u201cCompany\u201d), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced that it has commenced the commercial-scale production of batches of Trappsol\u00ae Cyclo\u2122, the Company\u2019s proprietary formulation of hydroxypropyl beta cyclodextrin. \u201cCyclo Therapeutics\u2019 robust, scalable and validated manufacturing process has been a cornerstone of our capabilities and enables us to move forward with all of our patient treatment programs,\u201d said Jeffrey L. Tate, Ph.D., Chief Operating Officer and Chief Quality Officer of Cyclo Therapeutics. \u201cThe production of our first commercial-scale cGMP batches of Trappsol\u00ae Cyclo\u2122 allows us to … Continue reading "Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-07-27T12:08:09+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210727005149r1&sid=flmnd&distro=nx&lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122\",\"datePublished\":\"2021-07-27T12:08:09+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\\\/\"},\"wordCount\":927,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20210727005149r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\\\/\",\"name\":\"Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122 - 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(Nasdaq: CYTH) (\u201cCyclo Therapeutics\u201d or the \u201cCompany\u201d), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced that it has commenced the commercial-scale production of batches of Trappsol\u00ae Cyclo\u2122, the Company\u2019s proprietary formulation of hydroxypropyl beta cyclodextrin. \u201cCyclo Therapeutics\u2019 robust, scalable and validated manufacturing process has been a cornerstone of our capabilities and enables us to move forward with all of our patient treatment programs,\u201d said Jeffrey L. Tate, Ph.D., Chief Operating Officer and Chief Quality Officer of Cyclo Therapeutics. \u201cThe production of our first commercial-scale cGMP batches of Trappsol\u00ae Cyclo\u2122 allows us to … Continue reading \"Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/","og_site_name":"Market Newsdesk","article_published_time":"2021-07-27T12:08:09+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210727005149r1&sid=flmnd&distro=nx&lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122","datePublished":"2021-07-27T12:08:09+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/"},"wordCount":927,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210727005149r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/cyclo-therapeutics-commences-commercial-scale-manufacturing-for-trappsol-cyclo\/","name":"Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol\u00ae Cyclo\u2122 - 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