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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 29 Aug 2019

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At a glance

  • Drugs Beperminogene perplasmid (Primary)
  • Indications Arteriosclerosis obliterans; Thromboangiitis obliterans
  • Focus Therapeutic Use
  • Most Recent Events

    • 22 Jan 2018 According to a AnGes MG media release, the company anticipates being granted conditional approval under the regulatory scheme of Approval with Conditions and Time Limit for regenerative medicines. The review process is expected to take approximately one year.
    • 22 Jan 2018 According to a AnGes MG media release, based on the positive results from the phase III trial (UMIN000000730) and this investigator-led clinical study (UMIN000014918) conducted in Japan, an application for marketing approval of HGF plasmid for the treatment of critical limb ischemia (CLI), the most severe condition of peripheral arterial disease, has been submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
    • 23 Aug 2017 Status changed from recruiting to active, no longer recruiting.
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