An investigational drug developed in Cuba for the potential treatment of Alzheimer´s and Parkinson's diseases has moved forward to phase III trials there, where scientists are optimistic about results of previous studies. The candidate, named Neuroepo and branded Neuralcim, was developed by the Center of Molecular Immunology (also known by its Spanish acronym CIM), a state-owned lab in the Caribbean nation.
It is planned to study 413 individuals in Havana alone, while the rest provinces, where health personnel in charge of conducting the phase IV clinical trial are being trained, aspire to include 1,456.
NeuralCIM, which already has a conditioned registration granted by the national regulatory authority, also has the potential to treat Parkinson’s, Ataxia and Acute Cerebral Ischemia.
”Erythropoietin was initially discovered as a hematopoietic growth factor. However, it has proved to be a promising molecule for treating neurological diseases (McPherson and Juul, 2008; Merelli et al., 2015). There is increasing evidence that this molecule plays a significant role in neural survival and functional recovery in animal PD models (Rey et al., 2019). Neuroprotection has been confirmed even with different administration strategies: intraventricular, intrastriatal, gene therapy, or grafted dopamine survival (Kanaan et al., 2006; Xue et al., 2007, 2010; Kadota et al., 2009).In clinical models, EPO has also been tested with reliable results. Pedroso et al. (2012) conducted a study on (n = 10) PD patients to evaluate the neuroprotective effect of Cuban recombinant human erythropoietin (ior-EPOCIM). They found that the drug was safe and well-tolerated (Pedroso et al., 2012). PD patients treated had clinically positive and statistically significant cognitive changes after the treatment. Jang et al. (2014) also confirmed that recombinant human erythropoietin (rhEPO) was safe and had beneficial effects on non-motor symptoms (Cognition, mood, and sleep/fatigue) of PD patients (Jang et al., 2014). However, rhEPO requires high doses and prolonged application, with the danger of producing adverse effects because of hematocrit and blood viscosity increment.For this reason, a new formulation of EPO with a low content of sialic acid has been developed, known as Neuroepo. This molecule is similar to that produced in the brain of mammals, maintaining its neuroprotective properties as shown in in vitro models (Garzón et al., 2018b) and animal experiments (Rodríguez Cruz et al., 2010, 2016). These studies showed that Neuroepo has the required lack of inducer effect on the synthesis of erythrocytes. Furthermore, Neuroepo was shown to be safe and well-tolerated in healthy people (Santos-Morales et al., 2017) and PD patients (Garcia Llano et al., 2021).”
I think it is interesting that it is an intranasal treatment since it sounds like Erythropoietin was usually given by injection when it was being used in the past
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