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 trial evaluating the safety and tolerability of intratumoral administration of ORCA-010 in treatment-naïve patients with localized prostate cancer.

Proposed period of release:
01/09/2019 to 31/12/2025

Name of the Institute(s) or Company(ies)
ORCA Therapeutics BV, Onderwijsboulevard 225,
5223 DE ‘s-Hertogenbosch,

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:
RNA Virus

Identity of the GMO:
Genus Mastadenovirus, family Adenoviridae, subgenus C, serotype 5

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
human adenovirus serotype 5MastadenovirusAdenovirussubgenus Chuman serotype 5-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known