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Cryoblation + Intratumoral injections

At the annual meeting of the American Association for Cancer Research held in April 2024 in California, the results of a clinical trial in 15 patients with metastatic prostate cancer treated with up to 12 cycles of:

Cryoablation + Intratumoral Injection of Ipilimumab + Nivolumab + CD40 + CpG.

This study was conducted by the Charles J. Link M.D. Lankenau Institute for Medical Research, Wynnewood, P.A.

crioablacion

The results obtained were extremely positive, with a response rate of a staggering 84%, of which 38.8% were complete responses (CR), i.e. total disappearance of the primitive tumour and all metastases, and 46.2% were partial responses (PR).

A partial response is defined as a decrease of at least 30% in the size and/or number of tumour masses.

Adding complete and partial responses together results in an excellent overall response rate of 84.6%.

There were no cases of disease progression and 15% stable disease throughout the 9-month clinical trial.

The rate of significant grade 3-4 side effects was very low. About 90% of the mild side effects were grade 1 or 2, and therefore of no clinical significance.

We are applying a protocol very similar to this one with a number of cycles of cryoablation plus intratumoral injection of up to a maximum of 6 cycles (6 months, one cycle per month) adding to the cocktail of immunostimulant drugs injected minutes after cryoablation a dose of 200 µg of GM-CSF (stimulating factor of colonies of granulocytes and macrophages).

We assume that despite the differences and specific characteristics that metastatic prostate cancer may have, these very high response rates can be achieved in at least 50% - 60% of most solid tumours: breast, colon, lung, etc. using the same protocol applied in this study.

On the other hand, in 2020 Dr. Gary Onik already published some very positive results in 26 patients: 19 of them with prostate cancer and 7 with colon cancer, melanoma, bladder, etc., applying only 3 cycles of cryoablation plus intratumoral injection of: ipilimumab, nivolumab and GM-CSF.

crioablacion

His result was significantly lower than that achieved in Dr Lynks' study discussed above, achieving only 40% responses (85% of which were complete). It appears that the number of cycles of cryoablation plus intratumoural injections together with the addition of CD-40 plus CpG significantly increases the final results.

In our opinion, the fact that high response rates are achieved using cryoablation instead of other heat ablative techniques (radiofrequency, microwave, etc.), which completely destroy the tumour cell by burning it, is due to the fact that freezing the tumour kills the cancer cell but when it is thawed its cellular structures: mitochondria, Golgi apparatus, nuclei, cell membrane with its cellular antigens are intact and intact.

Just as is currently happening with thousands of bacteria, viruses and other single and multi-cellular life forms that are thawed at the north and south poles in the process of global warming and are perfectly recognisable, as their cell organelles are intact.

And this is what happens with tumour-specific antigens in the thawing phase of cryoablation: they are perfectly recognisable by the antigen-presenting cells (APCs) and thus activate and strongly stimulate the immune system, which attacks and destroys the cancer cells, not only in the cryoablated tumour but also in other distant tumour masses (metastases).

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