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CTD Holdings, Inc. 8-K Report: Breakthrough in Niemann-Pick Disease Treatment

$CYTHW
Form 8-K
Filed on: 2018-02-06
Source
CTD Holdings, Inc. 8-K Report: Breakthrough in Niemann-Pick Disease Treatment

Key Information Extracted from the 8-K Filing for CTD Holdings, Inc. (Date: February 6, 2018)

  1. Company Information:
  • Name: CTD Holdings, Inc.
  • Incorporation State: Florida
  • Commission File Number: 000-25466
  • IRS Employer Identification No.: 59-3029743
  • Principal Executive Offices Address: 6714 NW 16th Street, Suite B, Gainesville, Florida 32563
  • Telephone Number: 386-418-8060
  1. Report Type:
  • This filing is a Form 8-K, which is used to report significant events that shareholders should know about.
  1. Event Reported:
  • Item 8.01 - Other Events:
    • CTD Holdings, Inc. has obtained preliminary data from clinical trials indicating that Trappsol® Cyclo™, a proprietary formulation of hydroxypropyl beta cyclodextrin, is capable of crossing the blood-brain barrier in individuals with Niemann-Pick disease type C.
    • The data were derived from:
    • A Phase I clinical trial in the United States (NCT02939547).
    • A Phase I/II clinical trial in Europe and Israel (NCT02912793).
    • Following intravenous administration of Trappsol® Cyclo™, it was detected in the cerebrospinal fluid of study subjects.
    • The clinical significance of these findings will be evaluated in the final analysis of both clinical trials.
  1. Emerging Growth Company Status:
  • The registrant has indicated it is an emerging growth company as defined under relevant regulations, but has not opted out of the extended transition period for complying with new or revised financial accounting standards.
  1. Signature:
  • The filing is signed by Jeffrey L. Tate, Chief Operating Officer of CTD Holdings, Inc., confirming the authenticity of the report.

Insights:

  • The preliminary data regarding Trappsol® Cyclo™ presents a significant potential advancement in treatment options for patients suffering from Niemann-Pick disease type C, a rare genetic disorder.
  • The ability of the formulation to cross the blood-brain barrier is critical as it may lead to new therapeutic approaches, warranting close monitoring of the ongoing clinical trials and their outcomes.
  • As an emerging growth company, CTD Holdings may benefit from certain regulatory advantages, including reduced disclosure requirements, which could impact investor perceptions and valuations.