Clinical trial with vaccine preparation Heberprovac in higher phase
Camagüey, Sep 26 (ACN) A Phase 2/3 clinical trial will be conducted from the first half of 2020 in Cuba with Heberprovac, a vaccine preparation developed by the Center for Genetic Engineering and Biotechnology (CIGB) of Camagüey (Cuba) to control advanced prostate cancer.
This will cover a total of 300 patients, a greater number than the two used previously in 2007 and 2011, which involved eight and more than 50 patients, respectively, explained Jesús Junco Barranco, head of the vaccine project, to ACN.
Unlike these first two studies, a control group will be included and, to evaluate what distinguishes it, it will be compared with Degarelix, one of the best medicines available to treat the ailment, produced by the multinational pharmaceutical company Ferring Pharmaceuticals, he explained.
Employed only during the first two stages in hospitals in the provinces of Camagüey and Holguín, in this new phase is expected to extend to the Institute of Oncology and Radiobiology, and the Center for Medical Surgical Research (CIMEQ) in Havana, and institutions located in Matanzas, Villa Clara and Santiago de Cuba.
According to Junco Barranco, four fortnightly immunizations and another three monthly immunizations will be administered to the patients on this occasion, and later they will receive radiotherapy, according to international practice, adding that depending on their evolution, vaccination will continue on a prolonged basis.
In addition to corroborating its safety and therapeutic efficacy, the clinical trial aims to confirm that it is capable of stimulating the immune system and modifying hormone concentrations and, therefore, controlling the disease.
The scientist commented that with Heberprovac, the only biotechnological product developed in Cuba for these purposes, it is also intended to demonstrate a lower index of adverse effects, to measure the time of progression of patients, and the evolution towards resistance to castration, which is considered the most serious and feared complication of prostate cancer.
He pointed out that it acts by an immunological mechanism, and although in the world there are precedents of vaccines in humans to face this ailment, none have been registered, and even no consistent phase 2 clinical studies are reported.
According to an article published in volume one in the Scielo digital scientific library, this year, this neoplasm is the leading cause of cancer death in men in the country, and it is the most frequent cause of cancer death in men in the world.
Heberprovac is the only product of Camagüey’s IGBC aimed at the biomedical branch, since the scientific institution was created three decades ago by Fidel Castro, with the objective of contributing to the search for solutions for animal and plant health problems.
Written by Radio Grito de Baire
