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Gene Therapy using Intramuscular Administration of AMG0001 in Patients with Peripheral Arterial Disease

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Trial Profile

Gene Therapy using Intramuscular Administration of AMG0001 in Patients with Peripheral Arterial Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Jul 2024

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At a glance

  • Drugs Beperminogene perplasmid (Primary)
  • Indications Arteriosclerosis obliterans; Chronic limb-threatening ischemia; Thromboangiitis obliterans
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 24 Jun 2024 According to an Anges media release, an application data package centered on results from investigator-led clinical study(UMIN000014918) and phase3 study (UMIN000000730) to be prepared and to submit a new application for manufacturing and marketing approval by the end of 2024.
  • 24 Jun 2024 Results published in an Anges media release
  • 24 Jun 2024 According to an Anges media release,based on results from investigator-led clinical study(UMIN000014918) and phase3 study (UMIN000000730), company has made decision to withdraw it's application for full approval for Collategene for use in patients with severe peripheral vascular disease,alongwith this the current product will be removed from Japanese market and company will be submitting a new application for peripheral arterial disease in Japan using global mutli-regional development strategy.

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