BioCen to request permission for clinical trial with Biomodulin T
Cuba´s National Center for Biopreparations (BioCen) will present a file to obtain approval of a clinical trial with Biomodulin T for Covid-19 convalescent patients, a local source reported.
The official documentation will be received by the Center for State Control of Medicines, Equipment and Medical Devices of Cuba.
BioCen also plans to present another clinical trial for SARS-CoV-2 positive patients and thus expand its use.
Mary Carmen Reyes, head of the clinical trials group in the Research-Development Directorate of said scientific entity, pointed out that her working team began a clinical trial in post-chemotherapy cancer patients as they are too vulnerable to Covid-19.
Likewise, an exploratory trial was conducted in chronic kidney patients with hemodialysis, laying the basis for further research.
She recalled that Biomodulin T has a health record since the 1990s for immune dysfunction states such as recurrent infections in the elderly.
Under such a condition - Reyes added - interventions started off in Cuba and based on the planned clinical trials, scientific evidence can be added to switch the applications of drugs and the number of doses.
The Biomodulin T is a 100% natural biological immunomodulator, not a blood derivative and a BioCen's own product, with extensive experience of treating the elderly with recurrent respiratory infections and excellent efficacy and safety results in 20 years used in medical practice, Reyes said.
Given the SARS-CoV-2 pandemic, Biomodulin T use was used nationwide as one of the first products to be included in the National Action Protocol for Covid-19 from a preventive point of view in the elderly.
(Taken from Prensa Latina)