Vivacelle Bio's President and Chief Innovation Officer to Present Data Highlighting the Company's Late-Stage Clinical Programs at the BIO International Convention 2024

2024-06-01

临床2期临床3期临床结果

Vivacelle is advancing a robust pipeline of therapies for shock and trauma-induced conditions

Vivacelle's pipeline is led by VBI-S, a Phase 3-ready asset designated for the treatment of hypotension and hypovolemia in septic shock patients, and VBI-1, a Phase 2-ready candidate for hemorrhagic shock.

KANSAS CITY, Mo., May 31, 2024 /PRNewswire/ -- Vivacelle Bio, a late-stage biopharma company developing life-saving treatments for shock and trauma, today announced that Cuthbert Simpkins MD, FACS, President and Chief Innovation Officer, has been invited by the National Institutes of Health (NIH) to present data highlighting the company's late-stage clinical programs at the 2024 BIO International Convention taking place in San Diego, CA from June 3 – 6, 2024.

Details of Dr. Simpkins' presentations are as follows:

Presentation Title: Multiple Clinical Problems Solved Using Phospholipid Nanoparticles

Date/Time: June 3, 2024, 2:45pm PDT

Track/Location: Company Presentations - Theater 3

Date/Time: June 4, 2024, 11:30am PDT

Track/Location: NIH Booth

"After a year of significant clinical milestone achievements, including the remarkable 100% efficacy results from our VBI-S Phase 2 trial, and a groundbreaking study published in The Lancet eClinicalMedicine, we are excited to engage with potential pharmaceutical and commercial partners, as well as investors, at BIO to discuss our product portfolio and plans to soon initiate a multicenter Phase 3 study of VBI-S," commented Harven DeShield, PhD, JD, MSc, CEO of Vivacelle.

Vivacelle's pipeline is led by VBI-S, a Phase 3-ready product built on the company's pioneering and patented phospholipid nanoparticle technology, which leverages the redistribution of nitric oxide to elevate blood pressure in hypovolemic septic shock, a leading cause of death that impacts millions around the world. A recently completed Phase 2 trial of VBI-S demonstrated 100% efficacy, with the treatment resulting in elevated blood pressure in hypovolemic septic shock patients who are refractory to therapy.

"Dr. Simpkins' presentation at BIO, along with substantial scientific and clinical evidence generated over the past decade, will highlight the innovative and effective nature of our phospholipid nanoparticle technology platform, initially targeting hypovolemia resulting from septic shock. Nearly 2 million people in the US develop sepsis annually, a condition that current standard-of-care treatments fail to adequately address. Our extensive clinical data indicates that VBI-S is not only safe but also significantly improves blood pressure and reverses organ failure—a critical factor in sepsis-related mortality. The promising and disruptive therapeutic impact of this product candidate for patients has been recognized by ongoing support from the US Department of Defense and the NIH. We are confident that our advancements and strategic market approach will be well received by the BIO community, paving the way for tangible next steps that will propel our mission forward," added Dr. DeShield.

Vivacelle Bio's Phase 2a clinical trial and ensuing multicenter Phase 3 study of VBI-S is funded by the Naval Medical Research Command (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.

The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.

About Vivacelle Bio

Vivacelle Bio is a late-stage biopharma company developing life-saving treatments for shock and trauma. The company's lead product, Phase 3-ready VBI-S, is built on its pioneering and patented phospholipid nanoparticle technology, which leverages the redistribution of nitric oxide to elevate blood pressure in hypovolemic septic shock, a leading cause of death that impacts millions around the world. A Phase 2 trial of VBI-S demonstrated 100% efficacy, with the treatment resulting in elevated blood pressure in hypovolemic septic shock patients who are refractory to therapy. In addition to venture capital, Vivacelle has garnered backing and financial support from the US Department of Defense and the National Institutes of Health. Vivacelle Bio is headquartered in Kansas City, MO. Learn more at https://www.vivacellebio.com.

SOURCE Vivacelle Bio