Initiating our ResusixTM Phase 1 studies signals our transition from a preclinical to a clinical stage product development company, which is an important milestone in our business strategy.
Research Triangle Park, NC (PRWEB) July 31, 2012
The life sciences development company Entegrion announced today it has been awarded $1.9 Million from the U.S. Office of Naval Research (ONR). The funding will be applied to two technologies: $825,000 will be used for further testing and development of a Multi-functional Resuscitation Fluid (MRF) that provides a safer and readily available alternative to blood transfusion. Entegrion will apply the remainder of the funds to Phase 1 studies for ResusixTM, its spray-dried, solvent detergent-treated human plasma that is being developed for use in certain applications as a substitute for fresh frozen plasma (FFP).
The Food and Drug Administration (FDA) recently allowed Entegrion to commence Phase 1 studies for ResusixTM. The product is Entegrion’s first Investigational New Drug (IND) filing.
“Initiating our ResusixTM Phase 1 studies signals our transition from a preclinical to a clinical stage product development company, which is an important milestone in our business strategy,” said Michael Galiger, Entegrion Vice President for Product Development. “This advance combined with our military’s demonstrated confidence in our unique abilities to meet their complex requirements clearly establishes our position in the blood therapeutics market.”
Entegrion is developing its MRF to address a critical need in trauma patients who suffer severe blood loss. Based on decades of research in human blood-derived therapies, the product’s goal is to replace lost volume, provide oxygen to tissues, and stop uncompressible hemorrhage preventing further blood loss. The MRF also will offer the portability and shelf-stable convenience of Entegrion’s distinctive portfolio of products.
Entegrion plans to begin Phase 1 studies for ResusixTM in the near future. Easy-to-use and fully portable, Resusix™ offers a valuable advantage in remote and austere military and civilian settings. With an extended shelf life of more than two years, the longer storage capacity breaks the cold chain restrictions of FFP, which is the current standard of care. Resusix™ also provides a safer alternative to FFP because it is free of micro particles and cell fragments commonly found in FFP.
To reflect the company’s growth and expanding base of products, Entegrion recently launched a new website at http://www.entegrion.com.
Entegrion is a life sciences company that is focused on improving the safety and availability of the world’s blood supply. Based in North Carolina’s Research Triangle Park, Entegrion offers patented technologies designed to overcome limitations in storage, safety, and availability of blood-derived products while preserving their functionality. Many of Entegrion’s advances in biologics are based on close collaborations with leading medical research institutions. Visit http://www.entegrion.com for more information.