Community prevention.

Sunday, October 3, 2021

NeuroEPO, "an intranasal formulation of recombinant human erythropoietin with a low sialic acid content" for Alzheimer. NeuroEPO, "una formulación intranasal de eritropoyetina humana recombinante con un bajo contenido de ácido siálico" para el Alzheimer.






One of the largest comets ever seen is making its way to our solar system

 Nearly 170,000 people suffer from dementia in Cuba, which means 10% of those over 65 and 1.3% of the general population

With 21% of its population aged 60 or over, the Caribbean nation is the oldest country in the region and it is estimated that by 2050 it will be one of the countries with the highest rate of demographic aging on the planet.

The prevalence of dementia syndrome in our country is estimated at 10.2 per 100 people 65 years and older, with Alzheimer's disease being its most frequent cause.


NeuroEPO is one of the most promising products in the portfolio of the Cuban Center for Molecular Immunology (CIM). During the latest proof-of-concept trial in Cuba, NeuroEPO acted as "a homeostatic regulator of the brain and improvement of cognitive deterioration in Alzheimer's patients," a report by Prensa Latina.

Cubadebate spoke with Doctor of Science Teresita Rodríguez, project manager of the NeuroEPO, of the CIM.

"With the increase in the life expectancy of the world's population, some of the neurodegenerative diseases such as Alzheimer's and Parkinson's have increased. This has motivated the scientific community since the last century, has been dedicated to the search for drugs that can stop its progress, without being able to achieve significant benefits with the drugs that are currently registered, "said the specialist.

One of the molecules most studied, he said, has been recombinant human erythropoietin, which has been used for more than 30 years in the treatment of anemia caused by chronic renal failure.

"Giventhe incidence of Alzheimer's disease in Cuba, which in 2016 was 1.2% of the Cuban population and which in 2030 may reach 2.9%, the Center for Molecular Immunology (CIM), together with other scientific institutions in the country, has carried out a project to obtain an erythropoietin with a low sialic acid content, that does not induce hematopoiesis and that has the same neuroprotective properties: NeuroEPO,"said the interviewee.

He pointed out that after long years of non-clinical, pharmaceutical, toxicological and efficacy studies in various animal and disease models, in which the safety of the molecule and its efficacy have been demonstrated, it has moved to the phases of clinical trials.

"From 2017 until the end of last year, the clinical trial of NeuroEPO for the treatment of Alzheimer's disease was carried out in order to demonstrate safety and efficacy. The results achieved in the trial show that there is a halt in the progression of the disease and that it improves aspects related to the cognitive sphere,"said Rodríguez.

Recently, Dr. Tania Crombet Ramos, director of clinical research at the Center for Molecular Immunology (CIM), commented at a press conference on the favorable data provided by this phase III, placebo-controlled clinical trial. "Itis an intranasal formulation, a very comfortable way of use for the patient and the caregiver. In this trial it was shown that we managed to improve neuropsychiatric cognitive impairment rates and also brain perfusion. We have evidence of mild and moderate Alzheimer's improvement with this molecule,"commented Crombet Ramos.

Rodríguez, for his part, pointed out that the successful response of the hypothesis raised in the protocol allowed to prepare the necessary documentation so that, in the month of May of this year, the document required to make the application for registration of the product was presented to Cecmed. "It is currently under evaluation by this regulatory entity and if registered it would go to the commercialization phase of it, which could be happening between 2022 and 2023," he said.

A new molecule called NeuroEPO, was proposed by the Center for Molecular Immunology (CIM) for official registration at the Center for the State Control of Drugs, Equipment and Medical Devices (Cecmed) with the aim of treating neurodegenerative diseases such as Alzheimer's, which in 2016 affected 1.2% of the Cuban population, with prevalence in those over 65 years of age.

According to the doctor of Sciences Teresita Rodríguez, project manager in an interview with Cubadebate, it is an erythropoietin with low sialic acid content, which does not produce serious adverse effects in the long term, and has neuroprotective properties.

"After long years of non-clinical, pharmaceutical, toxicological and efficacy studies in animals and diseases, the safety of the molecule was demonstrated and from 2017 to the end of 2020 the clinical trial was carried out that evidenced a halt in the progression of the disease and improvements in aspects related to the cognitive sphere," Rodriguez said.

Dr. Tania Crombet Ramos, director of clinical research at the Center for Immunology, said favorable data from the phase III, placebo-controlled trial. "This is an intranasal formulation, a very comfortable way of using it for the patient and the caregiver. We have evidence of mild and moderate improvement in Alzheimer's," he said.

Since May of this year, Cecmed evaluates the results of the NeuroEPO that if registered would go to the marketing phase as a drug between 2022 and 2023, according to CIM sources, thus concretizing a substantial effort as part of the National Plan for Dementias, approved by the Ministry of Public Health in our country, indicates Cubadebate.NeuroEPO: hope against Alzheimer's (+Video) › Cuba › Granma - Official organ of the PCC


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