In a report from Havana, the newspaper stated that the results of phase II and III of clinical trials conducted with the drug during 48 weeks showed that it is safe and well tolerated, with no serious adverse events.
La Jornada quoted Proyect Manager Teresita Rodriguez, who pointed out that a considerable number of patients showed a reduction in the progression of cognitive deterioration and improvement of secondary variables.
She added that two clinical trials are now planned: a comparative one in Havana, and the other one in the rest of the provinces in phase IV. In all cases, the participants will receive Alzheimer’s drugs.
On March 8, the Center for State Control of Medicines, Medical Equipment and Devices of Cuba approved the Conditional Health Registration of the NeuroEpo drug in cases of mild and moderate Alzheimer’s disease.
According to the document issued by the Center, the registration for NeuralCim (the trade name of NeuroEpo) was approved after evaluating the documentation submitted by the CIM, and will be valid for three years from the date of issuance of the registration certificate.
The description of the drug indicates that it is a nasal formulation of recombinant human erythropoietin (EPO) with a low content of sialic acid, an isoform with a composition similar to the one produced in the central nervous system.
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