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.