Vivacelle Bio, Inc. is a clinical stage company which has completed a Phase 2a clinical trial for the treatment of hypovolemia due to septic shock (VBI-S). Severe septic shock patients experience a drastic drop in blood pressure that is associated with multiple organ failure causing patient death. While conventional fluids are effective for treating absolute hypovolemia, they are ineffective for treating relative hypovolemia, which is caused by excessive production of nitric oxide (NO) in septic shock. VBI-S, which is administered intravenously, reversibly absorbs NO, reducing the bioavailability of NO. This first of its kind approach reduces the bioavailability of NO without interfering with its production or essential cellular interactions. In the VBI-S Phase IIa trial, reversal of relative hypovolemia led to an increase in blood pressure and improvement of organ function. All 20 patients enrolled in the trial met the primary endpoint of elevating mean arterial blood pressure by at least 10 mmHg within an average of 1.5 hours. The secondary endpoint which was to reduce the dose of vasopressors was also met. Significant improvements in tissue perfusion, inflammation, kidney, and lung function were also observed within 48 hours, with no drug-related adverse effects reported. Upon securing USFDA clearance, the company plans to also conduct a Phase 2b/III clinical trial for the treatment of hypovolemia due to septic shock. Our company has also been cleared by the USFDA to conduct a Phase 2a clinical trial for the treatment of hypovolemia due to hemorrhagic shock (VBI-1). We are currently focused on advancing our first two products (VBI-S and VBI-1) through the USFDA regulatory and approval process and ultimately making VBI-S and VBI-1 globally available to as many patients as possible via strategic licensing and co-development partnerships, global strategic development and commercial partnerships and non-dilutive funding and equity financing.
Vivacelle Bio, Inc. has developed a strong and robust patent portfolio comprising: 45+ issued patents on the platform and specific candidates (VBI-S and VBI-1) comprising Resuscitation Fluids, Compositions and method of treating conditions related to lack of blood supply, shock and neuronal injuries and Compositions and Methods for Reducing Reperfusion Injury. Patent applications are pending comprising Compositions and Methods for Treating or Preventing Multiple Organ Dysfunction and Compositions and Methods for Treating Hyperprocalcitonemia.
The Naval Medical Research Center through the Medical Technology Enterprise Consortium (MTEC) awarded Vivacelle Bio a $5,330,560 grant to complete our clinical trials with VBI-S for hypovolemia due to septic shock from Phase IIa through Phase III. Vivacelle Bio has also been awarded a $730,000 grant from the US Army grant for a preclinical study entitled, “Strategy for Warfighter Survival After Exsanguination.” The NIH awarded Vivacelle Bio, a $251,883.00 grant through its Small Business Innovative Research (SBIR), to evaluate a novel approach/ method of treating septic shock. Receipt of an NIH grant is a validation of the quality of our science and the alignment of our goals with the “NIH mission to enhance health, extend healthy lives, and reduce the burdens of illness and disability.”
Licensing and Co-Development
We are currently seeking primarily out-licensing and co-development opportunities for VBI-S and VBI-1 and our pipeline product for Reducing Reperfusion Injury. We are amenable to discussing co-development opportunities with respect to our pipeline products which are currently undergoing patent prosecution for Treating or Preventing Multiple Organ Dysfunction and for Treating Hyperprocalcitonemia. We are also amenable to entering into global strategic development and commercial partnerships and scientific research and development collaborations.