Development of VBI-1 as a novel treatment protocol for outpatient cardiac arrest

PROJECT SUMMARY Cardiac arrest (CA) is a life-threatening condition that can lead to loss of pulse, cessation of breathing, and unconsciousness. In the US alone, over 805,000 people are affected annually by CA, with the average survival rate being as low as 10.4%. CA is usually caused by reduced blood flow and ineffective cardiac output, which can result in post-cardiac arrest brain injury if not treated promptly. To improve clinical outcomes and survival rates, it's crucial to restore effective blood flow as soon as possible while minimizing the risk of reperfusion injury. Currently used resuscitation fluids are not effective in increasing blood pressure and may even contribute to further injury. Therefore, there is an urgent need for efficient interventions to improve coronary artery perfusion pressure and reduce reperfusion injury to minimize organ damage and ensure better survival of patients. Vivacelle Bio Inc. has developed a proprietary formulation called VBI-1, which is composed of micelles and liposomes. It acts as a colloidal volume expander, absorbs excessive nitric oxide and free radicals, and carries and releases oxygen. This formulation is specifically designed to address cardiac ischemia reperfusion injury. In a previous study using a rat model of cardiac arrest and clinical death due to rapid and severe blood loss, we demonstrated that VBI-1 infusion via the femoral artery was superior to all other fluids, including shed blood, in restoring spontaneous respiration and elevating blood pressure 4 hours after infusion. Our goal is to expand the use of intra-arterial infusion of VBI-1 to more common causes of cardiac arrest. In Phase II, Vivacelle Bio will perform Further preclinical validation, including biodistribution and bioavailability studies leading to IND application. Optimization of VBI-1 will be guided by studies of its mechanism or that of a modified form of VBI-1.