The Problem: Severe Community-Acquired Pneumonia (SCAP)
Severe CAP represents an enormous unmet medical need that despite antibiotics and improvements in the quality of medical care, carries a large and growing mortality rate. The initial infection can unleash an often deadly inflammatory cascade that can result in organ damage and organ failure. In what becomes a spiraling dysregulation of the immune response, inflammatory mediators begin to attack the epithelial lining of major organ systems. As more and more toxins enter the blood, this deleterious effect can affect multiple previously healthy organs. Death can come swiftly as toxins overwhelm the body’s ability to respond.
A Life and Death Problem
Jim Henson, an otherwise healthy 53-year old man and creator of the Muppets™ was experiencing a sore throat that lingered for several days. When he began to cough up blood he checked into NY Hospital on a Saturday with community-acquired pneumonia. By Wednesday, Jim died of cardiac arrest resulting from Septicemia caused by a group A streptococcus infection, a relatively non-lethal form of the bacteria that can cause Strep throat. However, if released into the bloodstream, it can unleash a dysregulated and cascading inflammatory storm that can ultimately attack otherwise healthy organs. Only weeks later, the Muppets™ were sold to Disney for $150MM.
Each year in the US alone, there are over 5 million ICU admissions with 250,000 deaths and 190,000 cases of secondary lung injury. Between 2000 and 2005, annual critical care medicine costs increased from $56.6 to $81.7 billion, in part due to the aging demographics of the U.S. population.
The annual incidence of pneumonia has been estimated to be 4 to 5 million cases per year in the US with approximately 25% requiring hospitalization. In a recent study of hospitalized patients with radiographically confirmed pneumonia (ref 14), the incidence of hospitalization was 24.8 cases (95% confidence interval, 23.5 to 26.1) per 10,000 adults or approximately 800,000 cases per year.
New treatments are needed to address the consequences of ICU admission and treatment, including the risk of organ failure, sepsis and the long-term morbidity following recovery from an incident resulting in ICU admission.
Plasma gelsolin’s distinct mechanisms of action can boost the immune response to pathogens and provide a systemic backstop that prevents the spread of inflammation, making it uniquely qualified to provide a safe and efficacious therapy in this challenging assault to the organism.
Source: Halpern NA, Pastores SM. Critical care medicine in the United States 2000-2005: an analysis of bed numbers, occupancy rates, payer mix, and costs. Crit Care Med. 2010;38:65-71.