It is our expectation that the availability of VBI-S upon Food and Drug Administration (FDA) approval will address the inadequacy of fluid therapy in raising blood pressure and minimize the widespread use of very high doses of vasopressors to treat hypovolemia in septic shock patients, possibly improve oxygenation in septic shock patients and ultimately, save numerous lives both in the US and globally." commented, "VBI-S holds the promise of accelerating our company’s efforts to promote phospholipid nanoparticle therapies for life-threatening diseases. Harven DeShield JD, PhD, the CEO of Vivacelle Bio, Inc. These results give us hope that VBI-S may be effective in late septic shock when all other measures have failed and even perhaps the downward progression of early sepsis can be thwarted." stated, "We are elated that in addition to the improvement of blood pressure in all of those who were given VBI-S, we are seeing some indications of the potential reversal of organ damage in multiple organs. VBI-S is an intravenously injected fluid that is comprised of phospholipid nanoparticles.Ĭuthbert Simpkins MD, the Chief Innovation Officer of Vivacelle Bio, Inc. Also, vasopressor drugs have potentially lethal side effects and often cease to be effective. However, too often reversal is not possible even after the infusion of currently available fluids and vasopressor drugs. Reversal of this drop in blood pressure significantly improves the chance of survival. 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. No drug related adverse effects have been observed in any of the patients in this study. In addition, clinically significant improvement in lung, kidney and liver function was observed. VBI-S was effective even in patients on very high doses of multiple vasopressors. All patients in whom vasopressors were weaned, reached the secondary endpoint of the trial which is a reduction in the dose of vasopressors. 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. KANSAS CITY, Mo., October 20, 2022-( 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.
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