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
A Phase I/II Open Label Clinical Trial Assessing Safety and Efficacy of Intravesical Instillation of the Recombinant BCG VPM1002BC in Patients with Recurrent Non-Muscle Invasive Bladder Cancer after Standard BCG Therapy

Proposed period of release:
30/11/2017 to 31/03/2022

Name of the Institute(s) or Company(ies)
Swiss Group for Clinical Cancer Research (SAKK), Effingerstr. 33, 3008 Bern, Switzerland;

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

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

If yes, notification number(s):

GMO characterization

GMO is a:

Identity of the GMO:
Bacteria; Actinobacteria; Actinomycetales; Corynebacterineae; Mycobacteriaceae; Mycobacterium; M. bovis; Strain BCG subtype Prague (recombinant Bacille Calmette Guérin (rBCG)).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
BCGMycobacteriumbovis-BCG subtype Prague-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known