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A Phase III trial of CLBS-14 in No-option Refractory Disabling Angina (NORDA)

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Trial Profile

A Phase III trial of CLBS-14 in No-option Refractory Disabling Angina (NORDA)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2022

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At a glance

  • Drugs CLBS-14 (Primary)
  • Indications Angina pectoris
  • Focus Registrational; Therapeutic Use
  • Sponsors Caladrius Biosciences; Lisata Therapeutics

Most Recent Events

  • 05 Aug 2021 According to an Caladrius Biosciences media release,discussions with the FDA have resulted in a rejection of the Company's efforts to reduce the FDA requirement of a 400-patient and as the enrollment of a study of this magnitude and design is projected to take many years, if executable at all, the Company has decided not to pursue a Phase 3 program for OLOGO™ on its own, but will continue to seek a partner to execute the study and advance the program.
  • 25 Feb 2021 According to an Caladrius Biosciences media release, the company remain in discussion with the FDA regarding the size and scope of this trial, in combination with previously filed Phase 1, 2 and 3 data, will be considered for the registration of OLOGO™.
  • 13 Aug 2020 According to an Caladrius Biosciences media release, this trial remains ready to initiate pending sufficient funding to run the program to completion and based on an abundance of very strong data from previous Phase 1, 2, and 3 studies, Caladrius remains confident in the potential for clinical success once the program is executed.

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