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.
VBI-S is an intravenously injected fluid that is comprised of phospholipid nanoparticles.
Cuthbert Simpkins MD, the Chief Innovation Officer of Vivacelle Bio, Inc. 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. 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.”
Harven DeShield JD, PhD, the CEO of Vivacelle Bio, Inc. commented, “VBI-S holds the promise of accelerating our company’s efforts to promote phospholipid nanoparticle therapies for life-threatening diseases. 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."
The clinical trial is funded by the Naval Medical Research Center (NMRC) – Naval Advanced Medical Development (NAMD) program utilizing the Medical Technology Enterprise Consortium (MTEC) Other Transaction Agreement (OTA) mechanism with the US Army Medical Research and Development Command (USAMRDC).
For more information on VBI-S or Vivacelle Bio, Inc., please contact Harven DeShield, J.D., Ph.D., CEO, at 716-830-8932 or via email, harven@vivacellebio.com.
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