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Country's Decision or any other Communication
Record information and status
Record ID
Date of creation
2018-02-27 23:27 UTC (tim.strabala@epa.govt.nz)
Date of publication
2018-02-27 23:27 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
New Zealand
Phone:+64 (0)4 474 5591
Fax:+64 (0)4 914 0433
Url:New Organisms, Environmental Protection Authority
Title / Reference number of the decision or communication
Date of the decision
Is the decision taken prior to entry into force of the Protocol?
Is this an amendment to a previous decision / communication?
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?
Does the decision apply to transboundary movements of LMO(s) into the country?
Importer’s or Applicant’s contact details
Oncolys Biopharma Inc
4-1-28 Toranomon
Minato-ku, Tokyo
Japan, 105-0001
Url:Oncolys Biopharma website
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Control 1 - The applicant must ensure that the organism (Telomelysin, OBP-301 as described in Table 1) is only administered:a) to individuals enrolled in a Phase 2 clinical trial approved under the Medicines Act 1981 to examine the safety and efficacy of Telomelysin in patients with inoperable stage IIIa and IV metastasised melanoma;
b) intratumourally;
c) by a suitably trained medical practitioner(s); and
d) at a Phase 2 clinical trial site2.
Control 2 - The New Zealand sponsor of the Phase 2 clinical trial3 must notify the EPA and Ministry for Primary Industries (MPI), in writing, and at least one calendar month before Telomelysin is administered for the first time at each clinical trial site, of:
a) the location of the Phase 2 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 patients who will be treated with the organism about the potential for Telomelysin to be transmitted to untreated individuals, particularly immunocompromised individuals, and the potential adverse effects of Telomelysin transmission;
b) educates patients in infection control; and
c) advises the patients to avoid contact with immunocompromised individuals
Control 4 - The New Zealand sponsor must ensure that a suitably qualified person(s):
a) before treatment, provides the patient with a biohazard container for any bandages, plasters or other dressings applied to the site of injection of the organism
b) before treatment, instructs the patient to return such containers to the Phase 2 clinical trial site for disposal as medical waste; and
c) disposes of such containers in accordance with medical waste disposal procedures in place at that Phase 2 clinical trial site.
Control 5 - The New Zealand sponsor must:
a) before the commencement of the Phase 2 clinical trial, ensure that protocols and suitably qualified people are available to investigate reports of adverse effects suspected to be related to Telomelysin transmission from treated individuals to untreated individuals;
b) ensure that reports of adverse effects reasonably suspected to be related to Telomelysin 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 Telomelysin-induced adverse effects resulting from confirmed events of Telomelysin transmission from Telomelysin-treated individuals to untreated individuals as soon as practicable
Control 6 - The New Zealand sponsor must submit a report describing compliance with the above controls to the EPA and MPI, initially to be submitted six months after the commencement of the Phase 2 clinical trial, then on or before 30 June every year thereafter until the conclusion of the Phase 2 clinical trial.
To manage environmental risk associated with the LMO.
Does the decision involve field trials?
Does the decision involve commercial release?
LMO identification
Risk assessment
Staff Assessment Report - APP202854
Decision document
Decision document