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Country's Decision or any other Communication
Record information and status
Record ID
113532
Status
Published
Date of creation
2018-06-25 08:20 UTC (tim.strabala@epa.govt.nz)
Date of publication
2018-06-25 08:20 UTC (tim.strabala@epa.govt.nz)

General information
Country submitting the decision or communication
  • New Zealand
Competent National Authority(ies) responsible for the decision or communication
Environmental Protection Authority
215 Lambton Quay
Private Bag 63002
Wellington
New Zealand
Phone:+64 (0)4 474 5591
Fax:+64 (0)4 914 0433
Email:neworganisms@epa.govt.nz
Url:New Organisms, Environmental Protection Authority
Title / Reference number of the decision or communication
Decision - APP203530
Date of the decision
2018-04-20
Is the decision taken prior to entry into force of the Protocol?
No
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Sillagen
11th Floor, HP bldg
83 Uisadang-daero, Yeongdeungpo-gu
Seoul
Republic of Korea
Phone:+82 (2) 368-2600
Url:SILLAGEN
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
Control 1 - The applicant must ensure that the organism (Pexa-Vec, pexastimogene devacirepvec; JX-594; as described in Table 1) is only administered:
a) to individuals enrolled in a Phase 1b clinical trial approved under the Medicines Act 1981 to examine the safety and efficacy of Pexa-Vec (either with or without the monoclonal antibody REGN2810) in patients with renal cell carcinoma;
b) intravenously or intratumourally ;
c) by suitably trained medical practitioners; and
d) at a Phase 1b clinical trial site.
Control 2 - The New Zealand sponsor of the Phase 1b clinical trial9 must notify the EPA and Ministry for Primary Industries (MPI), in writing, and at least one calendar month before Pexa-Vec is administered for the first time at each clinical trial site, of:
a) the location of the Phase 1b clinical trial site; and
b) the qualifications of the suitably trained medical practitioner(s) who will administer the organism.
Control 3 - The New Zealand sponsor must ensure a suitably qualified person(s), before treatment:
a) educates the individual who will be treated with the organism about the potential for Pexa-Vec to be transmitted to untreated individuals and animals (and potential adverse effects of Pexa-Vec transmission);
b) advises such individuals to report any adverse effects suspected to be related to Pexa-Vec transmission; and
c) instructs such individuals on pustule management practices (particularly to avoid contact with immunocompromised people if pustules form following treatment).
Control 4 - The New Zealand sponsor must ensure that a suitably qualified person(s):
a) before treatment, provides the individual who will be treated with the organism with a biohazard container for disposal of used pustule dressings;
b) before treatment, instructs such individuals to return these containers to a Phase 1b clinical trial site for medical waste disposal; and
c) disposes of such containers in accordance with medical waste disposal procedures in place at that Phase 1b clinical trial site.
Control 5 - The New Zealand sponsor must:
a) before the commencement of the Phase 1b clinical trial, ensure protocols and suitably qualified people are available to investigate reports of adverse effects suspected to be related to Pexa-Vec transmission from treated individuals to untreated individuals and animals;
b) ensure that reports of adverse effects reasonably suspected to be related to Pexa-Vec transmission are investigated to confirm whether or not transmission has occurred, and whether or not adverse effects have resulted from confirmed transmission; and
c) notify the EPA and MPI, in writing, of any occurrence of Pexa-Vec-induced adverse effects resulting from confirmed events of Pexa-Vec transmission from Pexa-Vec treated individuals to untreated individuals or animals as soon as practicable.
Control 6 - The New Zealand sponsor must ensure adequate stocks of Vaccinia immunoglobulin and cidofovir are stored by at least one Phase 1b clinical trial site for the duration of the trial in New Zealand.
Control 7 - The New Zealand sponsor must submit a report that shows compliance with the above controls, to the EPA and MPI, six months after the commencement of the Phase 1b clinical trial, then on or before 30 June every year thereafter until the conclusion of the Phase 1b clinical trial.
Reasons
To manage environmental risk associated with the LMO
Does the decision involve field trials?
No
Does the decision involve commercial release?
No
LMO identification
Pexa-Vec Vaccine
Production of medical or pharmaceutical compounds (human or animal) - Vaccines Selectable marker genes and reporter genes
Risk assessment
Staff Assessment Report - Application APP203530
Pexa-Vec Vaccine
Production of medical or pharmaceutical compounds (human or animal) - Vaccines
Selectable marker genes and reporter genes
Decision document
Decision document