Anvisa (National Health Surveillance Agency) authorized FUNDHERP (Fundação Hemocentro de Ribeirão Preto), in partnership with the Butantan Institute, to start a clinical trial in the country with a special medicine based on genetically modified cells, called CAR-T.
The research is considered another advance in the treatment of hematological (blood) cancer.
The information was released on Tuesday (26). The selection of patients who will take part in the study is still being defined.
Technique made promising advances in Brazil
Freepik
According to Anvisa, the work is in the initial clinical phase.
“The objective is to evaluate the safety and efficacy in the treatment of patients with relapsed and refractory B acute lymphocytic leukemia and B non-Hodgkin lymphoma, in cases of disease reappearance or resistance to standard treatment,” states the agency.
This new therapy uses the body’s own defense cells, modified in the laboratory, to attack lymphomas and leukemia.
“Both gene transfer technology, through a viral vector, and cell production technology are advances in development by national researchers”, adds Anvisa.
Art R7
Cancer patient had complete remission
In May of this year, a patient experienced complete remission of non-Hodgkin lymphoma (a type of cancer that originates in the lymphatic system) in just one month.
The evolution was celebrated by researchers, as he was one of 14 patients who participated in a study with CAR-T Cell therapy developed by the medical schools of USP (University of São Paulo) and USP of Ribeirão Preto, in partnership with Hemocentro from the city in the interior of São Paulo and by the Butantan Institute.
Writer and publicist Paulo Peregrino, 61, was diagnosed with his first non-Hodgkin lymphoma in 2018.
He had already tried everything to end the disease: he underwent chemotherapy and autologous transplantation — when the patient’s own hematopoietic stem cells are removed before administering high-dose chemotherapy and infused again after treatment. But none of that helped. The patient was on his third lymphoma.
Of the 14 participants, nine had complete remission. By comparing the image of exams before and after treatment, it is possible to see the remission of lymphomas in the patient’s body.
Imaging exam shows cancer before and after in a cured patient
reproduction
Peregrino’s treatment process with CAR-T Cell therapy began in December 2022, when he was admitted to Hospital das Clínicas to have his defense cells harvested.
He needed to go a month without chemotherapy for doctors to be able to collect the cells under the recommended conditions.
At the time, the team requested approval and authorization from Anvisa and Conep (National Research Ethics Committee) for the patient’s participation in the study and, once accepted, the defense cells from Peregrino’s body were collected and sent to the Ribeirão Preto Blood Center, where they were placed in culture.
Clinical trial approval
According to Anvisa, the objective is to boost the development of advanced therapy products available in the SUS (Unified Health System).
In January this year, FUNDHERP and the Butantan Institute were selected through a call for proposals.
“This initiated intensified regulatory support, aimed at improving and accelerating the pre-clinical data search phase to begin the clinical development phase of the product,” stated the agency.
Anvisa and the sponsors held several periodic meetings and constant data discussions and preparation of technical and regulatory documents, which were submitted continuously, with full priority on the part of the agency’s technical team.
There were 104 days of documentary evaluation carried out by the agency and 144 days of responses to the requirements worked on by FUNDHERP. After approving the start of the clinical trial, Anvisa created a monitoring plan.
“This involves frequent reviews of research data and information, with actions planned until December 2024, to closely monitor product development. If the results are good, the objective is to register the product quickly so that people have access to a safe, effective and high-quality treatment option available in the SUS,” stated the agency.
CAR-T Cell
Since 2020, Anvisa has registered three gene therapy products, of the CAR-T type, for the treatment of leukemias, lymphomas and myelomas and two gene therapy products for rare genetic diseases, developed by international biotechnology pharmaceutical companies.
With the publication of the first specific health standards for PTAs (advanced therapy products), Brazil joined the small group of countries with a regulatory basis for the development and use of these innovative products.
Currently, more than 40 clinical trials with experimental PTAs are underway in the country, following approval from Anvisa.
“A phase 1 clinical trial with a gene therapy product, called CAR-T, is being developed by Brazilian researchers at Hospital Israelita Albert Einstein, for the treatment of blood cancer,” adds the agency.
Global science is advancing rapidly to improve the quality of life for people around the world.
Advanced therapy products, which are a new frontier in medicine, are now available to many patients with serious or rare diseases who have no other treatment options. These products include gene therapy, cell therapies and tissue engineering.
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