1-877 BLACKPR (252-2577)
For Immediate Release
July 08, 2019
Contact Information

Cuthbert Simpkins MD, FACS
President and Chief Innovation Officer
Vivacelle Bio, Inc.
T: 318-771-1294
________________________________________

Harven DeShield, JD, PhD.
E: harven@vivacellebio.com
T: 716-830-8932
W: vivacellebio.com

(BPRW) Vivacelle Bio, Inc. Announces 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

(Black PR Wire) CHICAGO, ILLINOIS - Vivacelle Bio, Inc.  announces that the US Food and Drug Administration (FDA) has granted Dr. Cuthbert Simpkins, MD its Founder and Chief Innovation Officer,  an Investigational New Drug (IND) clearance to proceed with a phase IIa clinical trial of the safety and efficacy of VBI-S. Vivacelle Bio, Inc. provided support for the investigational new drug application to the U.S. Food & 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. See https://www.businesswire.com/news/home/20190215005521/en/Vivacelle-Bio-Receives-FDA-Clearance-Enroll-Patients.

Harven DeShield JD, PhD and CEO of Vivacelle Bio commented,  “The clearance of this IND will further accelerate our company’s efforts to promote phospholipid nanoparticle therapies for life-threatening diseases.  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. The combination of VBI-S and VBI-1 promises to be transformative with respect to providing critical technologies to address unmet medical need and save numerous lives both in the US and globally. ”

Cuthbert Simpkins, MD, Chief Innovation Officer and inventor of the Vivacelle Bio, Inc. technology stated, "Over the last 40 years there has been a tremendous increase in our understanding of sepsis.  But a solution has eluded us time and time again.  VBI-S is a different approach.  I am very excited about the possibility that VBI-S could be what the world’s medical community has been seeking for many decades.”

For more information on VBI-S or Vivacelle Bio, please contact Harven DeShield, JD, PhD,  (harven@vivacellebio.com) 716-830-8932   Company website: vivacellebio.com

Forward looking statement 

This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (I) change without notice, (ii) factors beyond the Company’s control and (iii) the financial capabilities of the Company. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.