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Notification report

Full notification file


General information

Notification Number
B/GB/13/R46/01/S

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
18/01/2013

Title of the Project
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure and Investigation of the safety and feasibility of AAV1/SERCA2a gene transfer in patients with chronic heart failure and a left ventricular assist device

Proposed period of release:
01/01/2013 to 31/12/2015

Name of the Institute(s) or Company(ies)
Celladon Corporation, ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; Denmark; United Kingdom; Netherlands; Sweden; Poland;

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

If yes, notification number(s):
B/BE/12/BVW2; B/SE/12/EU-2012-001700-37;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependovirus

Species: Adeno-associated virus (vector). The AAV1/SERCA2a vector is a recombinant adeno-associated virus (rAAV) vector. It is a pseudotype of AAV serotype 1(AAV1) and is denoted as rAAV1/2. As such, the capsid proteins are from wt AAV1 and the AAV DNA (two 145 base inverted terminal repeats) is from wtAAV2

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
AAV1	Dependovirus	Adeno-associated Virus	-	Serotype 1	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
22/04/2013 00:00:00
Remarks:
Consent granted for a gene therapy trial to improve calcium cycling in the hearts of heart failure patients. This will take place at a hospital in Scotland. Details as for the English application B/GB/13/R46/01.