Ann: Final Highest Dose in Phase 1 Clinical Trial of PD-VAXX, page-258

Great pick up on the paperwork Sister! Obviously having an infusion at the Alfred when PD1-Vaxx is a 0.5ml injection. So may be a historic photo as you & Davy have already thought of.

I don’t know what your situation in Melbourne is with COVID-19, but obviously with clinical trials of any kind, our number one priority is to protect patients & keep them safe from infection during trial visits, or as inpatients.

We have multiple contingency plans in place not just with NSW Health, but with clinical trial sponsors as well.

Some of those are alternative sites for visits with all equipment being validated in advance & permission granted from the trial sponsor if the PI requests this.

Prof Richardson has admitting rights across both hospitals that are major clinical trial sites, that is a possibility he may see trial patients at The Alfred as an alternative, but I can tell you now their Pharmacy would also need to be onboard to dispense trial drugs & complete all the necessary online dispensing for the trial as well and all staff involved registered & trained in trial protocol.

Just to reassure people, we have continued to screen & treat patients on drug during the whole Delta pandemic in a major tertiary COVID-19 hospital in Sydney with high case numbers & lockdowns & without issue. We have not had to use alternative sites with the procedures put in place.

I think it may have been an older photo used in Michelle’s story as well. I truly hope that treatment is working well for her, it’s an awful thing for such a young woman with children to go through with metastatic Ca & treatment, then for the cancer to return. My heart was broken so many times for patients & their families working in Palliative Care many years ago.

Just with what is occurring with Omicron here now in Sydney & Delta variant, it’s probably also a good time to reassure people worried, that contingency planning has been in place since 2020 for active clinical trials & is working very well, even though there have been nosocomial outbreaks which is always a massive concern & has resulted in some very sad outcomes for some patients & families.

Our patients on clinical trial drugs have continued to benefit, we know because an open label & other trials with ongoing monitoring appreciate telehealth.

There are special places in all trial protocols now, including for COVID-19 infection being reported as a SAE & vaccination status, which may not be appropriate at the point in time for all cancer patients depending on what prior treatment they have received recently.

Every stock I invest on, the patient cohort in clinical trials are high risk for COVID-19 severe infection. What I see clinically in the contingency efforts put in place over the last 2 years, and some trials successfully completed, has really allayed any real concern in this regard. Clinical Trials have evolved to mitigate risk. It’s clearly working.