Vivacelle Bio's VBI-S Phase IIa Clinical Trial Meets Primary and Secondary Endpoints for Treating Hypovolemia in Septic Shock Patients

KANSAS CITY, Mo., Feb. 10, 2023 /PRNewswire/ -- Vivacelle Bio, Inc., a privately held life science company focused on the development of treatments for hypovolemia in shock including septic shock and hemorrhagic shock, announced the successful completion of its Phase IIa clinical trial of VBI-S in septic shock patients with severe hypovolemia. Severe septic shock patients experience a drastic drop in blood pressure that is associated with multiple organ failure causing patient death. While conventional fluids are effective for treating absolute hypovolemia, they are ineffective for treating relative hypovolemia, which is caused by excessive production of nitric oxide (NO) in septic shock. VBI-S, which is administered intravenously, reversibly absorbs NO, reducing the bioavailability of NO. This first of its kind approach reduces the bioavailability of NO without interfering with its production or essential cellular interactions.

In the VBI-S Phase IIa trial, reversal of relative hypovolemia led to an increase in blood pressure and improvement of organ function. All 20 patients enrolled in the trial met the primary endpoint of elevating mean arterial blood pressure by at least 10 mmHg within an average of 1.5 hours. The secondary endpoint which was to reduce the dose of vasopressors was also met. Significant improvements in tissue perfusion, inflammation, kidney and lung function were also observed within 48 hours, with no drug-related adverse effects reported.              

The mortality rate of patients with septic shock is approximately forty percent (40%) with 270,000 deaths per year in the United States and eleven (11) million deaths per year worldwide. Reversal of the drop in blood pressure and improvement of organ function by targeting relative hypovolemia with VBI-S infusion in septic shock patients could be significantly important for improving the chance of survival of these patients.

Cuthbert Simpkins MD, the Sosland Missouri Endowed Chair in Trauma Services at the UMKC School of Medicine in Kansas City and the Chief Innovation Officer of Vivacelle Bio, Inc. stated, "We could not have imagined a better outcome for our clinical trial. We believe VBI-S is what physicians have been seeking for decades. We are very excited to have created a novel treatment for hypovolemia due to septic shock much different from the multiple treatment approaches for this life-threatening disease that do not work."

Harven DeShield JD, Ph.D., the CEO of Vivacelle Bio, Inc. commented, "contingent upon Food and Drug Administration (FDA) clearance, VBI-S represents a paradigm shift in the treatment of hypovolemia due to septic shock because it is very likely to markedly reduce the probability of a patient being placed on Extracorporeal Membrane Oxygenation (ECMO) after the failure of fluid therapy and vasopressors and potentially improve survival of patients."

The clinical trial is funded by the Naval Medical Research Center (NMRC) – Naval Advanced Medical Development (NAMD) program via the Medical Technology Enterprise Consortium (MTEC).

About MTEC

The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. For more information about MTEC, visit mtec-sc.org.

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, [email protected].

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.

Contacts

Harven DeShield, J.D., Ph.D., CEO
716-830-8932
[email protected].

SOURCE Vivacelle Bio, Inc.