Life Saving Innovations

Septic shock is a life-threatening medical condition that begins with an infection caused by pathogens such as bacteria, viruses, fungi, or parasites. Treatment begins with antibiotics or other medication to kill the pathogen. If possible the source of the infection is removed. Unfortunately, these measures are not always successful, and the patient’s blood pressure drops.

Initially, the decreased blood pressure is addressed by standard intravenous fluids such as Ringer’s lactate normal saline or albumin. If the problem is due to the lack of sufficient fluid volume in the blood vessels, a condition that is termed absolute hypovolemia, the blood pressure increases after infusion of these fluids. However if the drop in blood pressure is due to excessive production of nitric oxide that causes blood vessels to dilate, a condition termed relative hypovolemia, then the patient is in septic shock.

Standard fluids will not be effective and vasopressor drugs are used to raise blood pressure to the desired level of at least 65 mmHg.

Vasopressors have severe side effects and themselves can cause the patient’s demise. Eventually the blood pressure becomes unresponsive to vasopressors the vital organs fail and the patient dies. Attempts have been made to treat relative hypovolemia by blocking the production of nitric oxide. But the problem is that nitric oxide plays a role in essential functions such as energy production by mitochondria and regulation of the contraction of the heart.

Another problem is that in the microcirculation that supplies blood to vital organs some regions produce too much nitric oxide and others produce too little. Because of the critical and complex role of nitric oxide, a clinical trial in which the production of nitric oxide was blocked resulted in increasing mortality.

It was not until the development of Vivacelle Bio’s phospholipid nanoparticle based cardiovascular support fluid (VBI-S) that a breakthrough was made in the modulation of nitric oxide.

Because the phospholipid nanoparticles are volume expanding colloids they can correct absolute hypovolemia in the same manner as standard fluids. In fact VBI-S is superior to standard fluids in the treatment of absolute hypovolemia. The breakthrough is based on the fact that the relative hypovolemia caused primarily by the overproduction of nitric oxide is reversed by VBI-S. The key property is that nitric oxide is a lipophilic molecule which means that it prefers hydrophobic or oily environments.

Vivacelle Bio has created phospholipid nanoparticles (PN) that are hydrophobic (oily). The first of its kind working mechanism is that in septic shock patients the PN are infused IV which creates a hydrophobic space into which nitric oxide is absorbed. This reduces the bioavailability of nitric oxide without stopping its production or interfering with its essential interactions. Moreover, in regions of the microcirculation in which too much nitric oxide is produced it is absorbed by VBI-S and in regions in which not enough nitric oxide is produced the PN can release nitric oxide and increase concentration. The process can be summarized as a redistribution of nitric oxide from one that is consistent with mortality to one that is consistent with survival.

The results of our clinical trial in which 100% of the patients responded by meeting the endpoint of an increase in mean arterial pressure of 10 mmHg or more, the reduction of inflammation and improvement of the function of multiple organs are consistent with this mechanism. The high safety profile of VBI-S is supported by the fact that in the clinical trial no severe adverse events were attributed to VBI-S.