Portable Plasma? Enter Entegrion’s Resusix
Oct 10, 2011 20:32 EDT
(click to view full)
Your friend is on the ground, bleeding out. If you can’t replace the lost circulation volume, he’ll die quickly from shock. If the replacement you use hinders clotting, his odds to make it through the Golden Hour aren’t good. The bad news? Because of your location, frozen blood plasma isn’t available.
Entegrion, Inc. in Durham, NC thinks they have an answer, and the US Army is funding it with up to $43.8 million, to advance Resusix through phase II and phase III trials. What is Resusix?
It’s a temporary blood substitute. The Pentagon describes it as “Spray Dried Pooled Plasma.” Entegrion describes it as a “dehydrated, pathogen inactivated human plasma-based therapeutic for use in resuscitation… shelf-stable… that can be used to replace volume lost in bleeding, while maintaining functional blood clotting factors.” The dry plasma powder and the reconstitution fluid are currently stored in 2 separate bags, connected by tubing. To use Resusix, break the seal, and the fluid and powder are mixed and delivered.
Resusix will be Entegrion’s first Investigational New Drug (IND) filing, and the firm expects 10-15 clinical investigation sites to participate in each phase of the product’s clinical development. Site recruitment will begin in November 2011.
If Resusix succeeds, and passes its planned IND application submission in Q3 2011, the Army will have access to a blood replacement product that can live at forward firebases, deploy with Special Operations troops, and more. The immediate objective is to support the availability of plasma to forward surgical teams, and perhaps medical companies and aid stations. The Pentagon is conducting research on early administration of plasma. If that shown to be beneficial, a safer and more portable alternative to frozen plasma makes it possible to turn the concept in consistent reality.
Once it proves itself out, and passes the required government approval processes, civilian uses by first-responders and remote clinics would also beckon around the world.
Contracts & Key Events
Unless otherwise noted, contracts are issued by the U.S. Army Research Development & Engineering Command in Natick, MA, to Entegrion, Inc. in Durham, NC.
Oct 5/11: Funding to to advance Resusix through phase II and phase III trials. While the Pentagon’s release gave a $44.5 million total, DID has confirmed that the contract is structured as a base effort of $24.1 million for a 2-year period of performance, plus a 2-year, $19.7 option period to 2015 for the rest of the funding. Total: $43.8 million).
Work on this contract will be performed in Durham, NC, with an estimated completion date of Aug 29/15. The bid was solicited through the Internet, with 2 bids received (W911QY-11-C-0073). See also Entegrion [PDF] | Triangle Business Journal
Sept 3/10: An $8.2 million firm-fixed-price contract for continuing development of a method for aseptic production of dried human plasma for transfusion. Entegrion says that it will deploy the funds to scale up production, and to develop efficient manufacturing processes.
The estimated date of completion is Sept 1/12, with work to be performed at Durham, NC. Bids were solicited using Broad Agency Announcement with 1 bid received (W911QY-10-C-0141). See also Triangle Business Journal.
