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July 21, 2010

R&D Antibodies Chooses EmpiriStat to Collaborate for Important Research to Combat Sepsis

Press Release, 21 July 2010, 02:00 PM EDT 

Research & Diagnostic Antibodies Will Utilize Clinical, Data and Statistical Services from EmpiriStat


MOUNT AIRY, MD—EmpiriStat, Inc. announced today it has been contracted by Research and Diagnostic Antibodies (R&D Antibodies) to provide pivotal clinical trial services on their major sepsis project partially funded by the National Institute of General Medical Sciences (NIGMS), one of the National Institutes of Health (NIH). 


The award from NIGMS to R&D Antibodies will partially fund a pivotal clinical study designed to obtain FDA marketing clearance for a new in vitro diagnostic (IVD) test which is based upon a novel plasma biomarker discovered by R&D Antibodies that forecasts the onset of the sepsis pathology. In previous clinical studies this test was found to differentiate patients with Systemic Inflammatory Response Syndrome (SIRS, also called pre-sepsis) who will develop sepsis from those SIRS patients who will not develop sepsis. Results obtained from the iNOS test will allow physicians to treat their patients more effectively by starting antibiotic treatment and fluid resuscitation sooner.

EmpiriStat will be providing several services for R&D Antibodies in conjunction with this clinical study, including site selection, data management, statistical analysis, clinical monitoring, and safety reporting. This endeavor is indicative of EmpiriStat’s goals which are to collaborate with partners that share a common goal for the advancement of science in areas of research with high impact to public health. The team at EmpiriStat is very well aware of the increasing Sepsis issues being faced by hospitals and the risk to patients; and thus is excited to be part of the team working to solve these problems.
Plasma iNOS is the foundation of R&D Antibodies’ SIRS prognosis and monitoring tests that reveal very early the progression from SIRS into sepsis and indicate the course of this life-threatening pathology. R&D Antibodies has conducted three previous clinical studies, also partially funded by research grants awarded by the NIGMS, involving more than 290 ICU patients using tests based upon its patented anti-iNOS monoclonal antibodies. Plasma iNOS has been scientifically established as a specific, accurate and reliable biomarker for detecting very early the onset of sepsis. This new test identifies those patients who will develop the sepsis pathology 24-48 hours prior to the appearance of the physiological symptoms currently used by physicians as indictors of the onset of sepsis. Sepsis is the No. 1 killer in hospital ICUs, and according to the Centers for Disease Control (CDC), has a mortality rate of 30%. It is estimated that sepsis causes 250,000 deaths annually in the United States and 750,000 worldwide, and it is well accepted that better clinical outcomes are achieved when treatment is begun immediately after diagnosis. The cost of treating septic patients in an ICU can add $5,000 or more per day to a patient’s bill, where treatment lasts at least two days and often more than 20 days. Since one in eight ICU patients are at risk for sepsis, the cost in the United States to treat sepsis exceeds $30 billion a year.
About R&D Antibodies:

R&D Antibodies is a Las Vegas-based biotechnology company that develops monoclonal antibodies for both diagnostic and therapeutic applications by identifying novel extracellular proteins as biomarkers for important diseases with unmet clinical need. Their strategy is to target significant clinical market opportunities and to be first-in-class with novel diagnostics and companion monoclonal antibody therapeutics.
About EmpiriStat:

EmpiriStat is a woman-owned clinical trial partner specializing in biostatistics and statistical programming, supplemented by regulatory, clinical monitoring, safety reporting, data management and medical writing. EmpiriStat was founded with a unique goal: to discover the truth as far as possible. As biostatisticians and clinical trialists, they believe reaching this goal is only possible by going beyond analytics. For every research and development project, science and fact extend along a timeline in both directions-past, present and future. Applying rigorous methodologies and experience at every point along this timeline results in outcomes that are as close to the truth as possible.
EmpiriStat is committed to providing and maintaining the highest scientific rigor and ethical standards-while providing both timely and cost-effective services.

EmpiriStat, Inc.
Caylee Ortega, Director, Business Development
1.866.935.STATS (7828), ext. 707
[email protected]










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