Descripción del proyecto
Fármaco de la esclerosis múltiple para la insuficiencia cardíaca
La cardiopatía isquémica es la principal causa de muerte en los países en desarrollo con millones de casos solo en Europa. Está asociada con una disminución del flujo sanguíneo al corazón, la cual puede provocar infartos de miocardio. Para abordar la reparación del miocardio, la cual puede suponer el principal problema tras un infarto de miocardio, el proyecto ReDHeaD, financiado con fondos europeos, probará el fármaco Copaxone, aprobado por el Organismo para el Control de Alimentos y Medicamentos (FDA), el cual se utiliza en el tratamiento de la esclerosis múltiple. Los datos preclínicos demuestran una mejora significativa de los parámetros de la función cardíaca tras la administración de Copaxone. Los investigadores prepararán ensayos clínicos para validar la eficacia del fármaco en humanos y llevarán a cabo todas las actividades normativas y de comercialización necesarias para su rápida traducción clínica.
Objetivo
Coronary Heart Disease (CHD) and particularly Myocardial Infarction (MI), i.e. heart attack, is the leading cause of death in the Western world today. The main cause for CHD is the incapacity of the mammalian heart to undergo regeneration after injury. Current therapies are not able to address the central problem of decreased pumping capacity that results from the depleted pool of cardiac muscle cells. The outcome of this shortcoming is grim; nearly half of all patients with heart failure die within five years of the initial diagnosis.
We have tested a widely used FDA approved drug, Copaxone, which is used to treat Multiple Sclerosis, for its efficacy in heart repair and made a breakthrough discovery. Copaxone improved cardiac function and reduced scarring in a mouse MI model. Most of the treated mice (85%) responded to the treatment, exhibiting an average improvement of 44% in heart function parameters, along with 40% reduction in scar size.
In this PoC, we will expand these experiments by testing Copaxone using a chronic heart failure (CHF) model in both small and large animals (rats, pigs), and determine the optimal dosage regimen. Based on positive findings in this PoC, we plan to pursue Phase II clinical trials. The suggested activities include the preparation of the commercialization by interacting with key opinion leaders (e.g. cardiologists), who are in the position to speed up the clinical translation. We will also interact with pharma companies to build a potential collaborator and customer network. Eventually, we aim at commercializing repurposing existing drug to treat heart diseases, for CHF or acute MI indications. The impact of such therapy would be vast: CHD is the most common cause of death in Europe, accounting for 1.8 million deaths each year. As the original drug was already successfully commercialized by our institute, we can build on this experience and have the treatment available in approximately 5-6 years.
Ámbito científico
Programa(s)
Régimen de financiación
ERC-POC-LS - ERC Proof of Concept Lump Sum PilotInstitución de acogida
7610001 Rehovot
Israel