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: 24 Sep 2020
Price :
$35
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At a glance
- Drugs Beperminogene perplasmid (Primary)
- Indications Arteriosclerosis obliterans; Chronic limb-threatening ischemia; Thromboangiitis obliterans
- Focus Therapeutic Use
- 23 Sep 2020 Status changed from active, no longer recruiting to completed.
- 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.