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.
GSK releases decade-long data on Shingrix efficacy
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Charles River Laboratories launches AMAP to reduce animal testing reliance
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients