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

Award Number: R43GM143943
ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2021
PERIOD OF PERFORMANCE END DATE: 06/14/2023

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	VIVACELLE BIO INC	2300 MAIN ST	KANSAS CITY	MO	64108	JACKSON	USA	Biomedical Research and Research Training	000	1	12/5/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	VIVACELLE BIO, INC.	222 W MERCHANDISE MART PLAZA STE 1212	CHICAGO	IL	60654	COOK	USA	Biomedical Research and Research Training	000	1	4/1/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $251,883 )
2021	2021	VIVACELLE BIO, INC.	222 W MERCHANDISE MART PLAZA STE 1212	CHICAGO	IL	60654	COOK	USA	Biomedical Research and Research Training	000	1	9/7/2021	NEW	$251,883
														Subtotal = $251,883

Grand Total All Awards = $251,883

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

Award Number: R43GM143943

ORGANIZATION: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2021

PERIOD OF PERFORMANCE END DATE: 06/14/2023

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