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
It will come to one
pill against all types of cancer
? Expectations are high after the announcement of the
promising results of the new f
weapon against the cancer called AOH1996 (initials and year of birth of a girl who died of cancer at the age of 9, in 2005, ed)published by a group of oncologist researchers from City Hope of Los Angelesin the magazine Cell Chemical Biology. The new molecule, tested in the laboratory on 70 different cancer cells (including those derived from breast, prostate, brain, ovarian, neck, skin, lung cancer) it would seem effective in blocking the growth of tumors.
It should be noted that today it is about 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 of interacting with a protein, PCNA (“Proliferating cell nuclear antigen”, proliferating cell nuclear antigen ed), That essential for DNA replication, in particular, the drug developed interacts with an isoform of this protein, which is “cancer specific”. So it happens that this interaction interferes with DNA replication in the cancer cell and this, in turn, will lead to cell death caused by a DNA break; a “selective” death since it would only affect the cancer cells. Since this modified form of PCNA interacts with the new drug has been identified in different types of cancer, the molecule could in perspective somehow block the growth of different types of tumor. Currently, as for many anticancer molecules, – Dr. Normanno points out – a very interesting principle since the molecule could act both alone and by enhancing the activity of chemotherapy in particular.
Promising preclinical data
Where are we? Today we have gods preclinical data in cell lines and in experimental animal models
which 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; 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 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 trialTherefore the possible activity of the drug in humans is being 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 serves to determine how effective the drug is on symptoms, quality of life, survivalif it has any more benefits than similar drugs already on the market and what is the relationship between risk and benefit, as explained on 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 phase of experimentation positively, it must be manufactured by a pharmaceutical companywhich will then request authorization for marketing from the Regulatory Authorities
authorities, FDA in the United States, EMA in Europe, and then AIFA in Italy.
Do not create false expectations in patients
They will probably pass about ten yearsThereforebefore the new drug can actually be available to patients if it passes all stages of experimentation as 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, 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 highlight these results . But, out of respect for the sick people who suffer and their families, well don’t create false expectations
guy “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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