Policy & Regulation
Vivacelle Bio Wins FDA Clearance to Enroll Patients into a Phase IIa Clinical Trial of VBI-S for Elevation of Blood Pressure in Subjects Who Have Shock Due to Sepsis
11 July 2019 - - The US Food and Drug Administration has granted US-based Vivacelle Bio, Inc. founder and chief innovation officer Dr. Cuthbert Simpkins, MD an Investigational New Drug clearance to proceed with a phase IIa clinical trial of the safety and efficacy of VBI-S, the company said.
Vivacelle Bio provided support for the investigational new drug application to the US Food and Drug Administration for a phase IIa clinical trial of VBI-S.
VBI-S is an intravenously injectable fluid comprised of phospholipid nanoparticles that were specifically designed to shift the biophysical properties of the body's fluid volume in hypovolemic shock, due to sepsis, from non-survival to survival.
A fundamental problem is that molecules that alter the properties of the fluid volume in shock and cause loss of life, are also needed to sustain life.
Previous therapies blocked these molecules resulting in adverse effects and increased mortality or at best were ineffective. Instead VBI-S is designed to shift the balance of body fluid properties toward survival rather than eliminate these factors.
Also, because of the absence of a therapy that is effective in the late stage of sepsis there has been an emphasis on developing methods and products for early intervention.
However, early intervention is often not possible either because the patient presents late in the disease or the cause of sepsis is overwhelming.
VBI-S is at the vanguard of a paradigm change that promises to be effective in early or late sepsis.
Commitments have been obtained from key physicians at leading medical centers for participation in the study. Vivacelle Bio, Inc. is currently seeking funding opportunities to support performance of the clinical trial.
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.