Research & Diagnostic Antibodies LLC Receives Allowance For Key SIRS/Sepsis Diagnostic Patent In Europe

Main Category: Public Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Oct 2009 - 17:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Research & Diagnostic Antibodies LLC (R&D Antibodies) announced today that it has received a notification stating that the European Patent Office intends to grant a patent 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. This notification is equivalent to a "Notice of Allowance" by the United States Patent Office. European patent application 01959345 covers very broadly the use of R&D Antibodies' immunoassays, kits, and apparatuses for the detection of plasma iNOS as a biomarker for the prognosis and diagnosis of Systemic Inflammatory Response Syndrome (SIRS) that will deteriorate into sepsis. This European Patent Office allowance of claims extends R&D Antibodies' existing patent portfolio in this field (USA #6531578-B1 and 7198904-B1, European #EP1012605, Japan #4117911, and Australian #2001280912 and 782922). Equivalent patent applications are also pending in the USA, Japan, Australia and Canada.

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 clinical studies involving more than 295 ICU patients using tests based upon its patented anti-iNOS monoclonal antibodies. The last two clinical studies were partially funded by research grants awarded by the National Institutes of Health (NIH) after thorough peer review. 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 marker 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 is a strong addition to our intellectual property portfolio 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, 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 and severe sepsis impose upon the healthcare system."

About SIRS and 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 $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.

Several major healthcare systems have declared sepsis a major focus to improve the quality of care they provide to their patients and community. An industry leader, Mr. George Halvorson, Chairman and CEO of Kaiser Permanente, one of the largest HMOs in the USA, has publicly spoken about his concern for the high death rate and huge costs related to sepsis, and said even though 2% of all hospital patients in the state of California have sepsis and 23% of seniors in California hospitals die of sepsis, "No one is focusing on the sepsis problem." Mr. Halvorson also stated that once Kaiser Permanente learned the issues involved in sepsis and concentrated on aggressively treating the sepsis-specific problems, a 40% reduction in sepsis-associated deaths and a significant reduction in treatment costs were achieved. The early detection of pre-sepsis (also called SIRS) and sepsis is critical for patient survival, and further improvements will require earlier detection and better, more targeted therapy.

R&D Antibodies' blood test for iNOS identifies very early those patients who are entering sepsis, and allows 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 including aSeptiMab®, a chimeric human monoclonal antibody that specifically targets circulating iNOS that is currently in late stage preclinical development at R&D Antibodies. The candidate monoclonal antibody therapeutic forms a "theragnostic pair" with the new blood test.

Source
R&D Antibodies