Vivacelle Bio Announces Submission of an IND Application with U.S. FDA for VBI-S, an Injectable Fluid for the Treatment of Patients with Severe Septic Shock
- Category: Small Molecules
- Published on Friday, 07 June 2019 09:20
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- VBI-S is designed to elevate blood pressure of patients in severe septic shock in spite of the failure of current measures such as albumin, crystalloid, plasma, blood or vasopressor drugs.
- Phase IIa study expected to be initiated shortly after FDA review and clearance
CHICAGO. IL, USA I June 06, 2019 I Vivacelle Bio, Inc. today announced that it supported an investigational new drug (IND) application to the U.S. Food & Drug Administration for a phase IIa clinical trial of VBI-S, a phospholipid-based nanoparticle fluid that has the potential to elevate the blood pressure of patients who are suffering severe septic shock. Current therapy for these patients is either minimally effective or totally ineffective. By elevating blood pressure, the possibility of survival would be significantly improved. This announcement follows the FDA clearance in February 2019 of the company’s first patented and proprietary product, VBI-1, for a phase IIa clinical trial of its safety and efficacy after blood loss. See https://www.businesswire.com/news/home/20190215005521/en/Vivacelle-Bio-Receives-FDA-Clearance-Enroll-Patients.
Harven DeShield JD, PhD CEO of Vivacelle Bio commented, “It is widely known and acknowledged that current fluid therapies deployed to elevate blood pressure in septic shock patients are markedly inadequate. It is our expectation that the availability of VBI-S upon FDA approval will address the inadequacy of fluid therapy in raising blood pressure in septic shock patients. This IND demonstrates our company’s efforts to promote lipid emulsion-based therapies for life-threatening diseases.”
Cuthbert Simpkins MD, FACS the inventor of VBI-S stated, “I have been heartbroken by the loss of my patients who died as a result of severe septic shock since my surgical residency. I was committed and have been researching since my stint at the Naval Medical Research Institute. VBI-S is the solution I had been looking for which would offer hope to patients and their families.”
About Vivacelle Bio, Inc.
Vivacelle Bio, Inc. is a clinical stage biotechnology company that is focused on the discovery of new knowledge in the field of critical care and trauma. Currently, the company’s strategy is to develop and commercialize its discoveries that have led to a pipeline of products that are based on the biophysical properties of phospholipid nanoparticles and coupled with components of the aqueous phase. Various formulations are designed to counteract the adverse aspects of a broad spectrum of disease.
SOURCE: Vivacelle Bio