Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
The AGM0001Study: A phase 3 double-blind, randomized, placebo- controlled study to evaluate the safety and efficacy of AGM0001 in subjects with critical limb ischemia.

Proposed period of release:
01/08/2015 to 01/08/2020

Name of the Institute(s) or Company(ies)
University Medical Center Utrecht, Utrecht, the Netherlands;

3. Is the same GMO release planned elsewhere in the Community?

Has the same GMO been notified elsewhere by the same notifier?

GMO characterization

GMO is a:
Other: Purified plasmid DNA (pDNA) drug substance.

Identity of the GMO:
Not relevant. The plasmid DNA does not have a taxonomic classification.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known