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Notification report

Full notification file


General information

Notification Number
B/DE/09/PEI984

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
10/11/2009

Title of the Project
A Phase 1/2, Proof-of-Principle, Multi-Center, Open-Label, Single-Arm, Non-randomized Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine Consisting of Genetically Modified Allogeneic (Human) Tumor Cells for the Expression of IL-7, GM-CSF, CD80 and CD154, in Fixed Combination with a DNA-based Double Stem Loop Immunomodulator in Patients with Advanced Renal Cell Carcinoma (ASET Study)

Proposed period of release:
14/12/2010 to 30/06/2015

Name of the Institute(s) or Company(ies)
Mologen AG, Fabeckstr. 30
D-14195 Berlin
Germany;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
Other: False

Identity of the GMO:
Human renal cell carcinoma cells are transduced with human genes coding for GM-CSF, IL-
7, CD80 and CD154 by use of MIDGE vectors. Thereafter, the transduced cells are irradiated. The resulting GMO (MGN1601-W1) is used for the preparation of the cell-based vaccine MGN1601.

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
-	Homo	Sapiens		Caucasian, renal cell carcinoma

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
21/06/2010 00:00:00
Remarks: