Laurence M. Corash
Analyst · Stephens
Thank you, Kevin, I'd like to begin with an update on our INTERCEPT red cell development program, then provide some comments about recent positive data regarding the experience with INTERCEPT platelets and plasma in France and Switzerland, as well as the U.S. dialogue regarding ongoing risks of sepsis due to platelet transfusion. Primary reviews of our Phase III acute anemia clinical trial applications, or CTAs, have been completed in both France and Germany. We're still responding to a few remaining questions from the regulatory authorities, but do not see any barriers to initiating the study in the near term. We continue to anticipate starting enrollment later this quarter and expect this 50-patient study will take approximately 12 months to complete. In our other European red cell Phase III study planned for 70 patients with chronic anemia, we're actively preparing CTAs for submission to the Italian health authorities. We still believe this study can be initiated in 2012 or early 2013 in Cagliari and Torino, Italy, and completed in about 2 years. In the United States, we're working with sites in Milwaukee and Cincinnati for our red cell recovery and survival study, which we plan to initiate later this year. Note that we've previously quote this a Phase I study, but FDA recently indicated they considered this to be a Phase II study. So this will now be referred to as our U.S. Phase II trial in red cells, although the protocol remains unchanged. As a reminder, this study will include approximately 28 healthy volunteer subjects and is a prerequisite for entering Phase III studies in the United States. I'll now transition to some positive data for INTERCEPT coming out of both France and Switzerland. In June, we met with the French national agency for medicinal products, ANSM, for an annual review of the INTERCEPT platelet and plasma systems. This review encompassed 6 years of experience with INTERCEPT platelets and 5 years of experience with INTERCEPT plasma. I'm pleased to report that this review strongly supports the safety of INTERCEPT platelets and plasma, and ANSM did not express any concerns about the use of these products. In addition, Swissmedic, Switzerland's health authority, just released haemovigilance data for 2011. Their data confirmed successful implementation of INTERCEPT platelets at all 13 regional Swiss Red Cross blood centers, with INTERCEPT representing approximately 80% of the platelets produced last year. They observed the trend towards a reduction of severe transfusion reactions and have also seen no cases of bacterial sepsis in recipients of INTERCEPT platelets, reinforcing the value of the INTERCEPT technology to improve patient outcomes. Finally, I've just returned from a workshop in Bethesda, Maryland sponsored by the American Association of Blood Banks, or AABB, on the issue of bacterial contamination of platelet components. The purpose of this meeting was to consider the current level of risk posed by contaminated units and whether additional measures such as point of release testing should be implemented. You may have seen the recent article about this event that appeared in the Wall Street Journal. It was clear from the data presented that bacterial contamination remains a real concern despite widespread use of bacterial detection. Experts estimate that approximately 1 in 1,500 platelet units are contaminated, even with use of culture detection methods. This can translate to a patient risk of approximately 1 in 250 during a 30-day period of transfusion support because transfusion recipients usually receive multiple units over the course of their therapy. Also clear from the dialogue was that the addition of new tests can only incrementally reduce the problem, while adding complexity and expense for those performing the assay. The discussion perfectly illustrated both the need for and the advantages of using pathogen inactivation to protect platelet recipients from sepsis. Though this event was focused on the current situation in the United States, the inadequacy of bacterial detection methods is a global issue, and many of our customers choose INTERCEPT as a way to avoid or replace bacterial testing for platelet products. The U.K. recently announced the tender for evaluation of pathogen inactivation technology to potentially replace bacterial culture testing in the future. And we believe these events may influence other blood services using bacterial detection to consider use of pathogen inactivation. And now I'd like to turn the call over to Obi.