Welcome to the Champions blog. I am honoured and humbled that you have chosen to come on this journey with me. This is where I will give you exclusive insights into where your funds are going and how we’re progressing with our research. You can be as hands on as you like so if you would like to know more, you can call me any time. What I want you to know is that I will always be real and transparent with you – whether it’s about our successes or the challenges we face – where we succeed and where we fail. What you read in this research blog is my honest, raw opinion.
Together, we are leading the charge, pushing boundaries and willing to take chances that others won’t. I cannot express my gratitude enough for how much your loyalty and support means to me. We couldn’t do this without you. Thank you from the bottom of my heart.
The goal of The Champions is to extend the lives of people with brain cancer by contributing to the discovery of new treatments.
The initial focus will be on Glioblastoma Multiforme (GBM). GBM is the most common type of brain cancer. It is also the most deadly. Sadly, I cannot save people with GBM. I can only give them more time to spend with their loved ones and enjoy their last living months, by operating and removing their tumour. But it will return, and it will kill them. Even with surgery and therapies, people with GBM on average will die 15 months from their diagnosis.
As a neurosurgeon what I see most from my patients is shock and disbelief that there are no treatment options, that there are no clinical trials available to them. They do not want to accept this, neither do I, and by joining the Champions… neither do you.
The Champions Trial is set to be the first of its kind in the world to safely test experimental drugs on patients with the deadliest, incurable brain cancer. It is being developed in Australia by the Charlie Teo Foundation, and is funded by you – our Champions.
I want to kick off by answering some questions for you. These are the questions I have been asking myself and other experts over the last year.
Well, it’s not like people haven’t tried… Let me explain the history of GBM AGILE, which is an adaptive clinical trial platform. My old foundation gave $1.1 million in 2015 to bring GBM AGILE to Australia. And where is it? It never came! We recently contacted the group in the U.S. running GBM AGILE and they said they have no current plans to come to Australia, until maybe 2023. It’s only just gotten off the ground in the U.S. and they are having trouble recruiting drug companies. I’m still so angry that all that money didn’t go where I thought it was going, and I’m not going to make that mistake again.
Other reasons why it has never been done… Put simply, trials are expensive. Further, brain cancer is poorly funded in Australia by the Government because it does not affect enough of the population for Politicians to pay the attention it deserves and fund it in the way they do other cancers like for example breast cancer or prostate cancer.
I’m not arrogant enough to think that this is going to be easy. It won’t be. I believe that why other groups haven’t successfully done it is that they haven’t had the funding, the drive, the contact and the volunteerism that we already have in place. CTF has all of these things and is uniquely positioned to run this trial.
We began exploring all options for the design of the trial.
Key things we had in mind: Let’s not reinvent the wheel. Let’s start on an achievable scale, get the model right and then build it up from there. Past mistakes groups have made are where they tried to start too big, get too many sites and people with competing agendas involved upfront. Pretty quickly they hit the politics, ran out of funding and stalled completely.
One option we investigated and discarded was implementing an already established ‘adaptive’ clinical trials platform. This uses accumulated data in the trial to make pre-planned adaptations to the course of the trial. It sounds great in theory, but we found flaws…
There are currently 2 adaptive clinical trials platforms which have Food and Drug Administration (FDA) approval in the U.S. So we thought, could we bring one of these already approved platforms to Australia? The biggest problem our experts identified with these adaptive platforms is that drugs weren’t being tested at the same time and are being pitted against each other. The drug companies don’t like this, so can be reluctant to provide their drugs for the trial. These platforms are having real difficulties in recruiting enough experimental drugs to be trialled on patients.
Where we ultimately landed was on a multi-arm trial. The key difference is that it allows the comparison of several different experimental treatments at the same time within a single study.
DNA testing of each patient determines their diagnostic biomarkers, which we use to best match the patient to a treatment on an experimental arm. Further treatments can be added to the platform once there is sufficient data and/or an experimental arm is complete (meaning the markers of success are reached). If markers of success are favourable, the treatment could enter phase II & III trials.
We have assembled a lean team of experts, including a clinical trials manager, biostatistician, and clinicians, all in a voluntary capacity. We’ve visited a potential site to understand their protocols and how their expertise could be implemented within our multi-arm trials platform. From this we drafted a 70+ page protocol for how the trial platform would work.
It’s still early days but we have already put in the hard planning work upfront into the trial design. What we’re working on are the next steps towards ethical approval and pitching to pharma companies. We already have some pharma companies who have expressed interest in trialling their drug, which we’re excited about.
So we’ve still got a long way to go but with your help, we’re on our way to making this dream for patients a reality.
My commitment to you is to be fully transparent about where your generous donation has gone. We will show you how we have committed your funds, and when they have been spent. Now the program needs to be sustainable, so we won’t be spending it all at once. Rest assured, you have my personal pledge to spend your money well.
This blog is confidential with exclusive access granted by the Charlie Teo Foundation only to current members of The Champions.