# Nitric Oxide redistribution by a phospholipid nanoparticle colloid to treat septic shock.

> **NIH NIH R43** · VIVACELLE BIO, INC. · 2021 · $251,883

## Abstract

PROJECT SUMMARY
Septic shock continues to be a leading cause of morbidity and mortality worldwide. The increasing bacterial
antibiotic resistance is forcing the search for new methods to improve prognosis. Traditional resuscitation
therapy is not designed to address the physiological mechanisms of septic shock that contribute to
hypotension and organ failure. The inflammatory response is a limiting factor even with interventions such as
renal replacement therapy and extracorporeal membrane oxygenation. Vivacelle Bio has patented VBI-1, a
novel anti-inflammatory suspension of phospholipid nanoparticles designed to modulate the bioavailability of
nitric oxide (NO) responsible for excessive vasodilatation, hypotension, or dangerous reperfusion injury that
leads to organ failure in septic shock. Preliminary data support the ability of VBI-1 to carry life-sustaining
amounts of oxygen and to absorb reversibly and quickly NO. Because of this reversibility, VBI-1 represents
a novel approach to the modulation of NO that reduces its bioavailability without stopping its production or its
autocrine or paracrine effects. Through its NO uptake and release, VBI-1 acts as a high-capacity NO
modulator. At the same time, VBI-1 can carry oxygen and enable oxygen transport during resuscitation
therapy. VBI-1 also inhibits the inflammatory response, reducing ischemia-reperfusion injury and organ
dysfunction. Also, the small nanoparticle size and high emulsifier content of VBI-1 guarantee longer stability
and higher efficacy in raising blood pressure when compared to currently used resuscitation fluids. Finally,
VBI-1 is based on non-allergic soybean-oil micelles and liposomes comprised of phospholipid bilayers which
make the new formulation highly biocompatible. VBI-1 formulation has been successfully proven to treat
hemorrhagic shock with up to 55% replacement of blood volume without evidence of fat emboli, toxicity, or
lung injury. In this SBIR grant, Vivacelle Bio will validate VBI-1 as a superior product for intravascular volume
replacement compared to current resuscitation fluids, such as albumin or saline, in treating septic shock. To
establish the feasibility of this approach, we propose the following two specific aims: 1) demonstrate the
efficacy of VBI-1 when used in vivo on a Cecal Ligation Puncture (CLP) rat model of severe septic shock and
2) validate in vivo the NO modulatory effect by measuring NO biomarkers in the same CLP rat model. This
work will be preparatory for further studies in Phase II, aimed at optimizing the formulation of VBI-1 and
obtaining an FDA licensure for its use as a fluid for reducing the intensity of the inflammatory process in the
intravascular space.

## Key facts

- **NIH application ID:** 10321061
- **Project number:** 1R43GM143943-01
- **Recipient organization:** VIVACELLE BIO, INC.
- **Principal Investigator:** Cuthbert Ormond Simpkins
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $251,883
- **Award type:** 1
- **Project period:** 2021-09-15 → 2023-06-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10321061

## Citation

> US National Institutes of Health, RePORTER application 10321061, Nitric Oxide redistribution by a phospholipid nanoparticle colloid to treat septic shock. (1R43GM143943-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10321061. Licensed CC0.

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