Cerus Corporation (NASDAQ: CERS) is having an incredibly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced positive data from a key clinical trial late last night, leading to excitement among investors and sending the stock toward the top. Today, we’ll talk about the results, what we’re seeing from the stock, and what we’ll be watching for with regard to CERS ahead.
CERS Gains On Strong Phase 3 Data
As mentioned above, Cerus Corporation is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company released positive results from a key Phase 3 clinical trial. The trial is a transfusion study of chronic anemia. In the study, CERS was evaluating INTERCEPT- treated red blood cells (RBCs) in thalassemia patients.
According the release, the results from the clinical trial support the company’s INTERCEPT RBC CE mark submission. In the release, CERS said that the CE mark submission is planned for the second half of 2018. The primary efficacy endpoint used a non-inferiority design to assess up to a 15% relative difference in the mean consumption of hemoglobin between INTERCEPT-treated RBC and conventional RBC.
In the release, Cerus explained the study, in which 86 patients were enrolled at 3 participating international sites. Subjects within the study were randomly assigned to a sequential treatment period of either INTERCEPT-treated RBCs or conventional RBCs with cross over to the other treatment upon completion of the first treatment period. The company said that full results of the study are planned for submission and presentation at upcoming scientific conferences and for publication. In a statement, Richard Benjamin, CMO at CERS, had the following to offer:
These study results mark a major milestone in our mission to make INTERCEPT the standard of care in transfusion medicine. Thalassemia major patients require a lifetime of red cell transfusion, putting these individuals at elevated risk of transfusion transmitted infections from existing and emerging pathogens. We believe that the INTERCEPT Blood System has the potential to markedly reduce the risk of TTI for patients needing red cell transfusions.
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