New Platelet and Plasma Systems Show Promise

In two separate phase III clinical trials involving a platelet system and a plasma system, the primary endpoints for each were met. The systems are specially treated to protect against infectious disease transmission resulting from blood transfusion. The results of the trials were presented at the American Society of Hematology (ASH) meeting in Orlando (FL, USA).

The trial involved 671 patients, and the results supported the use of the platelets to treat and prevent bleeding during severe thrombocytopenia. The primary endpoint of the trial was designed to compare the incidence of moderate bleeding in patients who received the platelets and those receiving untreated platelets. The data showed that the proportion of patients with moderate bleeding was statistically equivalent between the two groups and within 1% of each other. The data also showed a statistically lower percentage of transfusion reactions with the treated platelets compared to the untreated ones.

A phase IIIB trial of the plasma system involving 121 patients was designed to determine whether the pathogen inactivation process affected therapeutic performance. The results were statistically comparable between the new plasma treated with pathogen inactivation and untreated plasma in the ability to treat and prevent bleeding in patients with acquired defects in coagulation, primarily due to end-stage liver disease. Safety and adverse events were also comparable.

The two systems, called Intercept, are being jointly developed by Baxter Healthcare Corp. (Deerfield, IL, USA) and Cerus Corp. (Braintree, MA, USA) to enhance the safety of blood transfusions. The Intercept blood systems are based on the Helinx technology of Cerus, designed to inactivate viruses, bacteria, other pathogens, and white blood cells.

In a related development, Baxter has entered into a worldwide agreement with Haemonetics Corp. (Deerfield, IL, USA) that will enable Haemonetics to integrate its platelet collection devices with the Intercept platelet system. Upon regulatory approval of the system, Haemonetics will offer its worldwide platelet collection customers an easy and economical way to incorporate the Intercept platelet system into their operations, making pathogen inactivation more widely available to platelet tranfusion recipients.




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