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.