Vivacelle Bio announced the US. Food and Drug Administration (FDA) has granted it an Investigational New Drug (IND) clearance to proceed with its phase IIa clinical trial of the safety and efficacy of VBI-1. VBI-1 is a paradigm-changing cardiovascular support fluid that is designed for the treatment of patients with emergently life-threatening conditions due to blood loss and other causes of severe hypovolemia (low blood volume). The treatment of hypovolemia and raising blood pressure are essential to survival of a broad range of critical conditions such as blood loss, burns, gastrointestinal losses, septic shock, acute radiation syndrome, or attacks utilizing biological or chemical weapons.
"This is the most transformational milestone achieved to date by our company. It is our expectation that the achievement of this milestone will serve as a launching pad to eventually providing critical technologies to address unmet medical need and save lives," Harven DeShield J.D., PhD and CEO of Vivacelle Bio said.
Commitments have been obtained from key physicians at leading medical centers for participation in the study. Vivacelle Bio is currently seeking funding opportunities to support its performance of the clinical trial.
"As a Trauma Surgeon I am grateful that my invention will save many lives which was my motivation for developing it in the first place," Cuthbert Simpkins, M.D., Chief Innovation Officer and inventor of the Vivacelle Bio technology said.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!