RE: New McMillan blog7 Jun 2023 08:24
WTP good find and Krafty, I've not met Prof. Lindy but would it be fair to say that for the genius she has, she seems extraordinarily modest ?
RW as you say - seems well recruited but I wonder if the 'one place remaining was at that particular Hospital ? Whatever, good stuff.
Here it is : 6 Jun 2023 "The ModiFY trial has started! Whoop whoop!
This is a trial of a new vaccine sponsored by Scancell. The official title is “A phase 1/2 open-label study of Modi-1 in patients with breast, head and neck, ovarian or renal cancer”. The objective is to find out if the modi-1 treatment can be used safely. There are two arms, one for people taking modi-1 only, and another with it combined with a checkpoint inhibitor eg nivolumab. The treatment contains three peptides (small parts of a protein) designed to help the immune system destroy the cancer by generating more T-cells.
What I didn’t realise about trials, was that the numbers are limited. This study has c138 participants and when my name was put forward by my oncologist there was only one place remaining and three standby places.
Signing the form was only the beginning. This really is a venture into the unknown. At the next session (screening), a humongous amount of bloods (about 15 vials) was required, ECG, a physical exam, and checks on my co-ordination, knee reflexes, including the heel-to-toe walk in a straight line you see on the TV conducted by the police to establish whether you are under the influence of drugs or alcohol. Needless to say, the outcome was OK.
A couple of weeks later I got an appointment for a CT scan with an iodine oral contrast (gastrografin) sent in the post that I was to drink with ½ pint of orange juice an hour beforehand. New! Googling this suggested it might not taste very nice, but it was nothing and I managed to devour it with zero incident on my train journey in.
Another change was to move my treatment base into the teaching hospital where my oncology unit is. Trial protocol can’t accommodate splitting treatments in different places, and that includes bloods. I now have a treatment schedule up until September. It’s so much busier than before.
Trial week 1 started on Monday 5th June. Pre-screening comprised bloods and more chit chat. Today (Tues) it was the Real Thing, the Modi-1 injection. It actually comprises 4 injections, each containing different peptides and the injection takes some time, about a minute each site. It uses a different needle to a covid vaccine, designed to achieve entry under the skin at 45o. I was anxious it might be like a rhesus negative anti-D injection which is quite “thick” and painful. I need not have worried. It was just a bit uncomfortable. Immediately afterwards there was some throbbing and significant skin reaction at the injection sites. This subsided after about an hour." . . . . . (cont'd)
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