Blood technologies company Entegrion has been awarded a $43.7 million defense contract to develop one of its investigational blood products into a substitute for fresh frozen plasma.
The Department of Defense will fund development of Resusix, Entegrion’s dehydrated human plasma. Resusix will become Entegrion’s first investigational new drug application filing. Research Triangle Park, North Carolina-based Entegrion expects to start recruiting clinical trial sites in the next month.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
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The Defense Department will fund Resusix through phase 3 clinical trials and a biological license application with the Food and Drug Administration. The contract is for $24 million for two years with an option of $19.7 million for an additional two years.
“We are extremely honored by the DoD’s ongoing support of the Resusix program,” Entegrion Chief Technology Officer Joseph DaCorta said in a prepared statement. “Our focus is to offer a safer and more effective alternative for frozen blood plasma, which often is not readily available in austere and remote locations.”
Resusix is freeze-dried human plasma that was developed as a shelf-stable alternative to fresh-frozen plasma, or FFP. FFP poses storage limitations because it must be kept frozen. It is also difficult to use in emergencies because it must first be thawed, which takes time. Resusix would be usable after quick rehydration with sterile saline.
Entegrion focuses on products that stop bleeding or address blood issues. The company’s first product was the bandage Stasilon whose proprietary weave promotes clotting. That product received FDA clearance in 2007. Entegrion had initially tried to take Stasilon to market on its own. But in April, Chicago wound care company Beeken BioMedical licensed Staslion and is now marketing the bandage. Entegrion has also developed another blood product called Stasix, a freeze-dried product made from blood platelets that can be rehydrated for use on patients whose bleeding is caused by low platelet counts.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Entegrion spun out from the University of North Carolina at Chapel Hill in 2002 as Hemocellular Therapeutics. The company has no venture capital backing opting instead to raise money from individual investors, many of them doctors. The company has also received several government grants and contracts. In August, the Navy extended a $9.84 million contract to study development of Resusix and Stasix as a possible life-saving fluid that could be used for military personnel in combat situations.
