Excerpt (translated into English):
Havana. The neuroprotective drug NeuralCIM – for nasal administration – offers Alzheimer’s patients in Cuba and other latitudes hope from science.
In the results of the phase II and III clinical trials with the drug for 48 weeks, it was shown that it is safe and well tolerated, without serious adverse events, highlighted Teresita Rodríguez, project manager.
A considerable part of the patients showed a reduction in the progression of cognitive deterioration and improvement of secondary variables, he added.
Now two clinical trials are planned: one in Havana, comparative, and another, in the rest of the provinces in phase IV. In all cases, the participants will receive medication for Alzheimer’s, said Rodríguez, quoted by the Scientific Observatory.
Of the total number of patients in the comparative study, some will be treated with NeuralCIM, while the control group will be given an international standard drug, the expert clarified.
The specific sites for these trials will be chosen in a meeting with specialists from the Cuban Ministry of Public Health.
The Center for the State Control of Medicines, Equipment and Medical Devices approved on March 8, according to Granma, the Conditional Sanitary Registry of the drug NeuroEpo in the indication of mild and moderate Alzheimer’s, reported yesterday through his Twitter account Eduardo Ojito Magaz, general director of the Center for Molecular Immunology, the institution that developed this molecule.
According to the document issued by Cecmed –shared by Ojito Magaz–, the Registry for NeuralCim (trade name of NeuroEpo) was approved after evaluating the documentation presented by the CIM.
It was also specified that the conditionality of the Registry of this product is established for the presentation of the results of a confirmatory phase III clinical efficacy study, which must request authorization within a period not exceeding six months.
Likewise, the registration granted will be valid for three years, from the date of issuance of the registration certificate.
NeuroEpo, developed by the CIM in collaboration with other BioCubaFarma institutions, is a nasal formulation of recombinant human erythropoietin (EPO) with low sialic acid content, an isoform with a composition similar to that produced in the central nervous system.
The results of the phase II and III clinical trial with this product in patients with mild and moderate Alzheimer’s were, as said, encouraging, as recently announced by CIM authorities.