Vivacelle Bio Announces Early Results of its Phase IIa Clinical Trial of VBI-S for Improving Hypovolemia Due to Sepsis.

2022-10-20

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. Forward looking statements This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (I) change without notice, (ii) factors beyond the Company’s control and (iii) the financial capabilities of the Company. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.