Research & Diagnostic Antibodies (R&D Antibodies), a biotechnology company that develops new monoclonal antibodies for diagnostic and therapeutic applications, has received a Notice of Allowance from the Japan Patent Office for its monoclonal antibody-based immunoassays and apparatuses for measuring inducible nitric oxide synthase (iNOS) as a plasma biomarker for the early detection of the sepsis pathology.

Japanese Patent Application #2003-517204 covers very broadly the use of R&D Antibodies’ immunoassays, assay kits, and apparatuses for the detection of plasma iNOS as an early biomarker for the prognosis and diagnosis of the life-threatening sepsis pathology. The JPO’s Allowance extends R&D Antibodies’ existing patent portfolio in this field (USA #6531578-B1 and 7198904-B1; European #EP1012605 and EP1412471; Japan #4117911; and Australian #2001280912 and 782922). Additional patent applications are pending.

Plasma iNOS is the foundation of R&D Antibodies’ sepsis prognosis and monitoring tests that reveal very early the onset of the sepsis pathology. To date R&D Antibodies has conducted three clinical studies involving more than 295 ICU patients to demonstrate the utility of this new plasma biomarker. The last two clinical studies were partially funded by research grants awarded by the National Institutes of Health (NIH) after thorough peer review. R&D Antibodies is currently working on a $2.6 M grant awarded by the National Institute of General Medical Sciences to conduct a pivotal clinical study which should generate the data required to obtain FDA marketing clearance for this new blood test.

Plasma iNOS has been found to be 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. In a direct comparison with the Procalcitonin test (an FDA-approved test for sepsis), plasma iNOS was found to be more specific than PCT and to be an earlier biomarker for the onset of the sepsis pathology. Plasma iNOS as a biomarker was shown to predict accurately the onset of sepsis in more than 96% of the severely injured ICU patients studied.

“This patent continues to build our intellectual property estate and adds to our leadership position in the early detection of sepsis,” said Dr. Robert Webber, Ph.D., president and CEO of R&D Antibodies, and the lead inventor on the patent. “Detection of circulating iNOS has broad application in numerous clinical settings including ICUs, emergency rooms, rehabilitation facilities, nursing homes, and outpatient clinics, and should guide physicians to initiate treatment earlier in this life-threatening pathology leading to reduced mortality and morbidity for the patient and reducing the huge financial drain that sepsis, severe sepsis and septic shock impose upon the healthcare system.”

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 more than 5,000,000 worldwide. It is also 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 $10,000 or more per day to a patient’s bill with treatments lasting 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 alone to treat sepsis exceeds $30 billion a year.

R&D Antibodies’ blood test for iNOS identifies very early those patients who are entering the sepsis pathway and once approved will allow the earlier initiation of current therapies such as IV fluids and antibiotics that should dramatically reduce both the number of deaths and the cost of treating septic patients. This new blood test should also enable patient stratification for the development of innovative new sepsis therapies. For example, aSeptiMab a candidate monoclonal antibody based therapeutic that specifically targets and neutralizes circulating iNOS. Currently, aSeptiMab is in late stage preclinical development at R&D Antibodies. Together, the new companion blood test and the candidate monoclonal antibody therapeutic form a “theragnostic pair” for improved personalized medicine.