On 10th January 2022, the EPA received a notification from MeiraGTx UK II Limited, 92 Britannia Walk, London N1 7NQ 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 AAV5-hRKp.RPGR, a gene therapy product which will be administered to patients suffering from X-Linked Retinitis Pigmentosa which is a genetic disorder of the eye which causes loss of vision.
AAV5-hRKp.RPGR is derived from wild-type adeno-associated viral vector serotype 5 (AAV5). It carries a healthy version of the Retinitis Pigmentosa GTPase Regulator (RPGR) gene.
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 location between 2022 and 2028.
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 or 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:
In reaching its decision, the Agency will take into consideration the views expressed by:
The notification documents are provided here below:
The applicant published a notice of the proposed deliberate release, in the Irish Times (13 January 2022) inviting members of the public to make representations to the EPA within 28 days of publication of the notice in a newspaper (i.e. up to 5pm on 22 February 2022).
GMO Register Entry
The proposed clinical trial has been assigned GMO Register No G0786-01. The Register provides significant details about the trial. The register entry will be updated as further details become available.
Summary Notification Information Format (SNIF)