GMO Register No: G0784-01
SNIF Notification No: B/IE/21/01
On 1st December 2021, the EPA received a notification from Gyroscope Therapeutics Ltd., Rolling Stock Yard, 188 York Way, London N7 9AS, United Kingdom, seeking consent under Article 14 of the GMO (Deliberate Release) Regulations, S.I. No 500 of 2003, to carry out the deliberate release of a Genetically Modified Organism (GMO).
The GMO is GT005, a gene therapy treatment which will be administered to patients suffering from the eye disease, geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
GT005 is derived from wild-type adeno-associated viral vector serotype 2 (AAV2). It has been modified to deliver a gene called Complement Factor I (CFI) to cells in the eye. GT005 is not capable of replication.
The patients will participate in two clinical trials. Both trials will use the same GMO at different doses. The purpose of the trials will be to test whether a single administration of GT005 is effective at slowing the progression of the disease and that it is safe.
The clinical trials will take place at the following locations between January 2022-July 2026
(Patient follow up will continue for a further 5 years after treatment).
Any person or organisation proposing to carry out a deliberate release of a GMO for purposes other than placing on the market (for example, the performance of trials) must comply with the legislative requirements set out under Part II of the GMO (Deliberate Release) Regulations S.I. No 500 of 2003.
In accordance with the Regulations, it is the role of the Agency to assess the risks posed by the proposed deliberate release to human health and the environment.
The Agency must respond to the applicant in writing within 90 days of receipt of the notification. This does not include any period during which the Agency is awaiting a response to a request for further information. In its response to the applicant, the Agency may indicate that consent to the proposed deliberate release is:
refused, and the reasons for the refusal.
In reaching its decision, the Agency will take into consideration the views expressed by:
The notification documents are provided here below:
The proposed clinical trial has been assigned GMO Register No G0784-01. The Register provides significant details about the trial. The register entry will be updated as further details become available.