Vivacelle Bio announced it supported an investigational new drug (IND) application to the U.S. Food & Drug Administration (FDA) 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 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.
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“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,” Harven DeShield JD, PhD CEO of Vivacelle Bio said.
“I have been heartbroken by the loss of my patients who died as a result of severe septic shock since my surgical residency,” Cuthbert Simpkins MD, FACS the inventor of VBI-S said. “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.”