by Maria Giovanna Faiella
The results of preclinical studies are promising: the new drug would block the growth of different types of tumours. But it must be tested on humans. In-depth study with the oncologist
Will there be a pill against all types of cancer? Expectations are high after the announcement of the promising results of the new cancer drug called AOH1996 (initials and year of birth of a 9-year-old girl who died of cancer, in 2005, ed.), published by a group of oncologist researchers from the City Hope of Los Angeles, in the journal Cell Chemical Biology. The new molecule, tested in the laboratory on 70 different cancer cells (including those derived from breast cancer, prostate, brain, ovaries, neck of the uterus, skin, lungs) would seem effective in blocking the growth of tumors.
It should be noted that to date these are preclinical studies carried out only on cellular and animal models. The first phase of human trials has just begun. one of the many promising therapies but we are far from saying that an anti-cancer panacea comments the past president of the Italian Cancer Society, Nicola Normanno, director of the Translational Research Department of the IRCCS National Cancer Institute – Pascale Foundation of Naples.
How the new molecule would act
How would this new drug work? The mechanism of action – explains the oncologist – consists in interacting with a protein, PCNA (“Proliferating cell nuclear antigen”, ed.), which is essential for DNA replication, in particular the drug developed interacts with an isoform of this protein, which is “cancer specific”. It therefore happens that this interaction interferes with the replication of DNA in the cancer cell and this, in turn, will lead to the death of the cell caused by a break in the DNA; a “selective” death since it would only affect the cancer cells. Given that this modified form of PCNA that the new drug interacts with has been identified in several types of cancer, the molecule could potentially block the growth of several types of cancer in some way. Currently, as for many anticancer molecules, – Dr. Normanno points out – a very interesting principle since the molecule could act both on its own and by enhancing the activity of chemotherapy in particular.
Promising preclinical data
Where are we? Today we have preclinical data in cell lines and in experimental animal models that show the activity of this drug – underlines the oncologist -. It cannot be said that the new molecule “kills” tumors but that it blocks the growth of some tumors in experimental systems; it also shows a possible synergism with chemotherapy, increasing its effectiveness but always at a preclinical level. It should be emphasized that many therapies have worked at a preclinical level but then, unfortunately, have not passed human trials.
First phase of human trials, what it consists of
Now the phase 1 study of experimentation of the molecule on humans has just begun. 8 patients will be enrolled, reports Dr. Normanno, who explains: In phase 1 studies, increasing doses of the drug are used up to the maximum tolerated dose. The purpose is to evaluate the toxicity and therefore the degree of safety of the drug. Once the phase 1 experimentation is over, the dose to be used for the phase 2 experimentation is identified, then the possible activity of the drug in humans begins to be evaluated. It should also be remembered – underlines the oncologist – that many drugs that gave positive responses in phase 2 of the trial, then did not pass phase 3, when the experimental drug is compared to standard therapies.
How long before it is available
The phase 3 study is used to determine how effective the drug is on symptoms, quality of life, survival, if it has any more benefits than similar drugs already on the market and what is the relationship between risk and benefit, as explained in the portal of the Italian Medicines Agency (AIFA). In this case the patients “enlisted” are hundreds or thousands.
If the drug were to pass this experimental phase positively, it will have to be produced by a pharmaceutical company, which will then request authorization for marketing from the competent regulatory authorities, the FDA in the United States, EMA in Europe, and then AIFA in Italy.
Do not create false expectations in patients
Therefore, it will probably be about ten years before the new drug can be truly available to patients if it passes all the phases of experimentation, resulting effective and safe, and is authorized for marketing by regulatory bodies.
Normanno says that, in addition to dealing with translational research at the Pascale Tumori Institute, he is involved in the clinical management of patients: In recent years there have been many innovations in the oncological area that have improved diagnoses and therapies for patients and it is right to emphasize these results . But, out of respect for the sick people who suffer and their families, it is good not to create false expectations such as “there will soon be a miracle pill to cure all types of cancer”.
August 6, 2023 (change August 6, 2023 | 2:53 pm)
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