Studies related to the neuroprotective drug NeuralCIM (NeuroEPO), for the treatment of Alzheimer’scontinue in Havana with the beginning of the consultations for the classification of the patients that will integrate the phase III clinical trial.
The first deputy director of the Center for Molecular Immunology (CIM), Kalet León, commented to the press that the search for potential candidates is already taking place with a view to beginning, later, this phase of the study of the drug, while later a phase IV in other provinces of the country, as reported the agency Latin Press (PL).
The NeuroEPO molecule, an erythropoietin with a low sialic acid content very similar to the one that naturally originates in the brain, proved to have beneficial effects in patients with mild and moderate Alzheimer’s, after the first clinical investigations carried out in Cuba.
[1/2] #NeuralCIM (NeuroEPO) for treatment of Alzheimer’s disease #Alzheimer’s mild or moderate is one of the innovative products of the @cim_cuba.
We share updated information on clinical trials with this drug and the possibility of accessing classification queries.#Thread pic.twitter.com/OFkJFrZwwU
— Scientific Observatory (@ObservaCiencia) July 6, 2022
In turn, the doctor of science Teresita Rodríguez, product manager, explained that the formulation proved to have a low level of adverse effects and, at the same time that it promotes the formation of new blood vessels and the expansion of neurotransmitters, it prevents cell death and has an anti-inflammatory effect, among other benefits.
For her part, Dr. Leslie Pérez also commented that for these new phases of the studies, the Cuban product will be compared with the drug Donepezilo, approved by the regulatory agency of USAaccording to the news agency.
The specialist added that particularly in Havana, in addition to the clinical characterization, the patients participating in the trial will be evaluated from the molecular point of view, through the determination of beta-amyloid proteins in the cerebrospinal fluid, whose accumulation in the brain it is identified as a precursor to Alzheimer’s.
In the Cuban capital, it is planned to study 413 people, while in the rest of the country, where the personnel who will conduct the phase IV clinical trial are trained, they aspire to include 1,456, the expert stressed, quoted by PL.
The dossier to request the initiation of the following investigations is currently in the stage of preparation for delivery to the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), the Cuban regulatory authority.
Once the approval of this body is obtained, it is expected to begin the studies during the last quarter or four months of the current year, the specialist pointed out.
PL recalls that the NeuralCIM drug already has a conditioned registration granted by the CECMED, since it also has the potential to be used in the treatment of Parkinson’s, Ataxia and Acute Cerebral Ischemia, according to its managers.
The drug, created by the CIM, is administered orally and seeks to restore the imbalance caused by neurodegenerative conditions in the brain and stabilize its physiological functioning, the agency specifies.
