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 3 clinical trial approved under the Medicines Act 1981 to examine the safety and efficacy of Pexa-Vec in patients with hepatocellular carcinoma;
b) intratumourally;
c) by a suitably trained medical practitioner(s); and
d) at a Phase 3 clinical trial site
Control 2 - The New Zealand sponsor of the Phase 3 clinical trial 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 3 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 3 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 3 clinical trial site.