{"id":48936,"date":"2022-09-28T21:02:16","date_gmt":"2022-09-28T19:02:16","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/cyclo-therapeutics-provides-business-update\/"},"modified":"2022-09-28T21:02:16","modified_gmt":"2022-09-28T19:02:16","slug":"cyclo-therapeutics-provides-business-update","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/cyclo-therapeutics-provides-business-update\/","title":{"rendered":"Cyclo Therapeutics Provides Business Update"},"content":{"rendered":"
\n

\n\u2013 Company on track to commence enrollment and dosing of Phase 2 study of Trappsol\u00ae<\/sup> Cyclo\u2122 for the treatment of Alzheimer\u2019s disease before year end<\/i>\n<\/p>\n

\n\u2013 Ongoing advancement of global pivotal study (TransportNPC\u2122) evaluating Trappsol\u00ae<\/sup> Cyclo\u2122 for Niemann-Pick Disease Type C1 (NPC1)<\/i>\n<\/p>\n

\n\u2013 Company to participate at the 2022 NPUK Annual Family Conference & Interactive Workshop on Niemann-Pick Disease<\/i>\n<\/p>\n

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 provided a business update and reiterated upcoming milestones.\n<\/p>\n

\n\u201cWe are very pleased with our progress advancing our clinical programs evaluating Trappsol\u00ae<\/sup> Cyclo\u2122 for the treatment of NPC and Alzheimer\u2019s disease. Of note, plans for our Phase 2 Alzheimer\u2019s disease study remain on track to enroll and dose patients before the end of this year. Additionally, we are advancing our TransportNPC\u2122 study and continue to build momentum related to enrollment. In addition to advancing the NPC clinical study, our team continues to dedicate time and effort to engage with the global NPC community. We are executing on all fronts and remain focused on driving the development of Trappsol\u00ae<\/sup> Cyclo\u2122 forward. The remainder of the year is poised to be exciting for Cyclo Therapeutics,\u201d commented N. Scott Fine, CEO of Cyclo Therapeutics.\n<\/p>\n

\nNiemann-Pick Disease Type C1 Development Program<\/i>\n<\/p>\n

\nThe Company continues to advance enrollment in its ongoing pivotal Phase 3 study, TransportNPC\u2122. The Phase 3 study intends to enroll at least 93 pediatric (age 3 years and older) and adult patients with NPC1 in at least 23 study centers in 9 countries. Eligible patients will be randomized 2:1 to receive either Trappsol\u00ae<\/sup> Cyclo\u2122 or a placebo. Randomization will not be constrained based on patient age, nor will patient enrollment be gated by patient age. The study duration is 96 weeks and includes an interim analysis at 48 weeks.\n<\/p>\n

\nCyclo Therapeutics is committed to connecting with the global NPC community and helping to drive awareness of this rare disease. As part of those efforts, the Company will participate at the upcoming NPUK Annual Family Conference & Interactive Workshop on Niemann-Pick Disease being held October 6-7, 2022 in Wyboston Lakes, Bedfordshire. As part of the conference, there will be an overview of Cyclo Therapeutics\u2019 Phase 3 global clinical program, TransportNPC\u2122, and Professor Caroline Hastings, MD, Global Principal Investigator for the TransportNPC\u2122 study will participate in a panel discussion.\n<\/p>\n

\nNPUK is a charitable organization dedicated to making a positive difference to the lives of those affected by Niemann-Pick diseases. Its conference will bring together attendees from the UK and throughout Europe, including patients and families, clinicians, researchers and members of industry. Toni Mathieson, CEO of NPUK and Founding Member of International Niemann Pick Disease Alliance, commented: \u201cI believe it is only through thoughtful collaboration among industry, advocacy organizations, patients and the medical community that we can bring safe and effective treatments to those living with NPC. Cyclo Therapeutics shares this goal and has been a valuable partner for many years. We are grateful for their ongoing commitment to our NPC community in the UK and around the world, and look forward to their participation in our conference.\u201d\n<\/p>\n

\nFor more information about the conference, please visit www.npuk.org<\/a>.\n<\/p>\n

\nAlzheimer\u2019s Disease Asset<\/i>\n<\/p>\n

\nCyclo Therapeutics continues to progress its plans to evaluate Trappsol\u00ae<\/sup> Cyclo\u2122 for the treatment of Alzheimer\u2019s disease, targeting the reduction of amyloid beta and tau. In December 2021, the Company received IND clearance from the U.S. FDA to advance its Phase 2 study of intravenous Trappsol\u00ae<\/sup> Cyclo\u2122 for the treatment of Alzheimer\u2019s disease. Clinical site selection is underway, and the Company remains on track to commence patient enrollment and dosing before the end of this year.\n<\/p>\n

\nAbout Cyclo Therapeutics<\/i><\/b>\n<\/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 four formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, (www.ClinicalTrials.gov<\/a> NCT02939547, NCT02912793, NCT03893071 and NCT04860960). The Company is planning a clinical trial using Trappsol\u00ae<\/sup> Cyclo\u2122 intravenously in Alzheimer\u2019s disease based on encouraging data from an Expanded Access program for Alzheimer\u2019s disease (NCT03624842). 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

\nSafe Harbor Statement<\/b>\n<\/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

Contacts<\/b> <\/p>\n

\nJTC Team, LLC
\n
Jenene Thomas
\n
(833) 475-8247
\n
CYTH@jtcir.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u2013 Company on track to commence enrollment and dosing of Phase 2 study of Trappsol\u00ae Cyclo\u2122 for the treatment of Alzheimer\u2019s disease before year end \u2013 Ongoing advancement of global pivotal study (TransportNPC\u2122) evaluating Trappsol\u00ae Cyclo\u2122 for Niemann-Pick Disease Type C1 (NPC1) \u2013 Company to participate at the 2022 NPUK Annual Family Conference & Interactive … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-48936","6":"format-standard","7":"category-industry"},"yoast_head":"\nCyclo Therapeutics Provides Business Update - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/cyclo-therapeutics-provides-business-update\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cyclo Therapeutics Provides Business Update - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"\u2013 Company on track to commence enrollment and dosing of Phase 2 study of Trappsol\u00ae Cyclo\u2122 for the treatment of Alzheimer\u2019s disease before year end \u2013 Ongoing advancement of global pivotal study (TransportNPC\u2122) evaluating Trappsol\u00ae Cyclo\u2122 for Niemann-Pick Disease Type C1 (NPC1) \u2013 Company to participate at the 2022 NPUK Annual Family Conference & Interactive ... 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