Vivacelle Bio’s VBI-S Phase IIa Clinical Trial Meets Primary and Secondary Endpoints for Treating Hypovolemia in Septic Shock Patients
KANSAS CITY, Mo.--(BUSINESS WIRE)--Vivacelle Bio, Inc., a privately held company focused on the development of improved treatments for septic shock, today announced early results from its Phase IIa clinical trial of VBI-S in septic shock patients. Each of the thirteen (13) patients treated so far in the trial met the primary goal which was an elevation of mean arterial blood pressure by at least 10 mmHg. All patients in whom vasopressors were weaned, reached the secondary endpoint of the trial which is a reduction in the dose of vasopressors. VBI-S was effective even in patients on very high doses of multiple vasopressors. In addition, clinically significant improvement in lung, kidney and liver function was observed. No drug related adverse effects have been observed in any of the patients in this study. A severe drop in blood pressure occurs in septic shock patients leading to a mortality rate of approximately forty percent (40%) with 270,000 deaths per year in the United States and eleven (11) million deaths per year worldwide. Reversal of this drop in blood pressure significantly improves the chance of survival. However, too often reversal is not possible even after the infusion of currently available fluids and vasopressor drugs. Also, vasopressor drugs have potentially lethal side effects and often cease to be effective.