A protocol to solicit the phase III clinical trial and the conditioned registration of the biotechnological Cuban product Jusvinza is being designed by researchers of the Center for the Genetic Engineering and Biotechnology and specialist linked to the rheumatoid arthritis and the respiratory distress disorder.

Gillian Martínez, Ph.D. in Biologic Science and manager of the Jusvinza project, in the frame of the International Congress Biohabana 2022, released the information about this immuno-regulator peptide used in the treatment of these diseases and hyper-inflammation.

As for rheumatoid arthritis clinical trials phase I and II were performed with positive results, which evidenced the improvement of life quality of the volunteers while demonstrating a safer administration of the product and its ability to regulate the immune response without inducing immunosuppression.

The investigator stressed out that Jusvinza was evaluated in Covid-19 patients with respiratory distress and showed its capacity for preventing it, increasing the chances of overcoming the disease of those critical and seriously ill while diminishing the time for mechanical invasive ventilation.   

Martínez detailed that the product was used as part of the national acting protocol against Covid-19 and studies were performed out of Cuba, in which it was also evidenced its capacity of enhancing the choices of overcoming the disease on critical and seriously ill patients while diminishing the time with mechanical ventilation.

These results, insisted, are the winning card for the proposal made to the Center for the State Control of Medicine, Equipment and Medical Devices for the approval of clinical trial phase III both in rheumatoid arthritis and respiratory distress plus the conditioned registration in both applications.

The clinical trial in respiratory distress will not only attached to Covid-19 patients but also to other diseases that might cause it, like pneumonia, sepsis and pancreatitis, she specified.

Jusvinza is obtained at the manufacturing facilities that comply with the good manufacturing practices, which is one of the requirements that are needed for getting the conditioned registration, she pointed out.

Photo: ACN