Kedrion Melville Inc., a US-based company owned by Kedrion, entered into an agreement with the US-based company Entegrion Inc. for the development and marketing of Resusix™, a virus inactivated spray-dried plasma, treated with solvent-detergent, to be used as a replacement of frozen fresh plasma.
The Phase-I clinical trials that have recently been authorised by the Food and Drug Administration (FDA) will be conducted by Entegrion Inc., a company specialising in services to enhance the safety and availability of plasma.
The intended use of Resusix™ is in resuscitation, when major haemorrhages occur. The product proved to be suitable for being stored for a few years if kept at a temperature of +2/+8°C or for a few months if kept at room temperature. In addition, this kind of plasma comes in a form that can be easily transported.
The development of Resusix™ is supported by the US Department of Defence, which understood its potential use in first aid during military actions. If expectations are supported by the clinical trials, the product might be used for civilian applications in any outdoor emergency as well.
Under the agreement between Kedrion Melville Inc. and Entegrion Inc., Kedrion S.p.A. will manage the plasma production and control process, while Kedrion Melville Inc. will have exclusive global rights for the sale of Resusix™ .
“Our objective is to complete the clinical development process as soon as possible – stated Paolo Marcucci, CEO of Kedrion – to offer a product that can be used in any circumstance, regardless of the need to maintain the cold chain, which is currently the only available plasma-storage system. As a matter of fact, this product can be reconstituted in just a few minutes, turning from powder to liquid, to produce the same amount as a normal transfusion. This will help save human lives in all those circumstances in which timely assistance is currently hampered by logistic difficulties”.
“This is further evidence – Marcucci concluded – of Kedrion’s innovation and research capabilities and of its bent for forming effective alliances with excellent partners”.