Positive results of the third phase of the new treatment for thalassemia January 30, 2018 Source: WuXi PharmaTech Cerus recently announced that the company's Phase III Clinical Blood Transfusion Study of Chronic Anemia has successfully reached its primary endpoint. This study evaluated the efficacy and safety of red blood cells treated with the INTERCEPT system in clinical trials after entering the patient. The INTERCEPT system is a technology developed by Cerus that can process platelets and plasma in whole blood or single sample volumes with high throughput and effectively inhibit the growth of pathogens in the sample. SPARC's findings provide important clinical data on the safety of INTERCEPT-treated red blood cells in patients with chronic input, supporting the submission of the INTERCEPT RBC CE marker planned for the second half of 2018. The primary efficacy endpoint of the study was the use of a non-inferiority design to assess the relative difference in mean hemoglobin consumption between INTERCPT-treated RBC and conventional RBC by up to 15%. Safety endpoints included the incidence of specific treatment-associated burst antibodies, the incidence of antibodies to erythrocyte alloantigens, the incidence of adverse events, and the incidence of transfusion reactions. A total of 86 patients were enrolled in this double-blind, crossover study. Subjects were randomized to a continuous treatment group of INTERCEPT-treated RBC or conventional RBC, and other treatments were cross-administered after the end of the first treatment period. Each treatment cycle consists of 6 blood transfusions. A total of 2006 units were input during the study, with 999 in the control group and 1007 in the test group. The full results of the study are planned to be announced at the upcoming scientific conference. In addition to the SPARC study of thalassemia patients, the company's planned CE mark in 2018 will also include the results of the European Phase 3 clinical study that the company has successfully performed in patients with acute anemia. In the United States, the company is conducting a phase 3 study of INTERCEPT treatment of red blood cells (RedeS) in Puerto Rico Island to improve the risk of Zika virus and is preparing to launch a separate phase III study of INTERCEPT for the treatment of red blood cells, 600 receiving complex hearts Patients undergoing vascular surgery (ReCePI) support the FDA's potential pre-market approval application (PMA) for the red cell INTERCEPT blood system. â–² Dr. Richard Benjamin, Chief Medical Officer of Cerus (Source: Cerus Official Website) "These findings mark an important milestone in our development of INTERCEPT care standards in transfusion medicine. Patients with thalassemia major need to have red blood cells throughout their lives, placing these individuals at high risk of existing and emerging pathogens transfusion-transmitted infections (TTIs). Dr. Richard Benjamin, Chief Medical Officer of Cerus, said: "We believe that the INTERCEPT blood system has the potential to significantly reduce the risk of TTI in patients who need to infuse red blood cells. Reference materials: [1] Cerus official website [2] Cerus Reports Positive Top-Line Results from Chronic Anemia Phase 3 Study Evaluating INTERCEPT Red Blood Cells in Thalassemia Patients Ice Hair Removal,Ice Laser Hair Removal,Ice Therapy Hair Removal,Ice Cold Ipl Hair Removal Shenzhen Jie Zhong Lian Investment Co., Ltd. , https://www.szmeizons.com
