New Protein Technology Licensed to Beckman Coulter

(Lexington, MA, USA).

Beckman Coulter plans to use the HMGB1 technology to develop an immunoassay for detecting and managing inflammatory diseases. In return, Critical Therapeutics will receive a license fee, and has the potential for future development milestones and royalties contingent on sales of any diagnostic assay resulting from the agreement.

HMGB1 belongs to a class of proteins called pro-inflammatory cytokines and is secreted by the immune system as part of the body's response to trauma and infection. Critical Therapeutics believes HMGB1 may be an effective therapeutic target for acute diseases resulting in multi-organ failure, including sepsis and septic shock. Sepsis and septic shock conditions affect more than 10% of the 14 million patients treated annually in U.S. intensive care units and kill more patients than breast cancer, colorectal cancer, pancreatic cancer, and prostate cancer combined.

"Furthermore, we believe the ability to detect and measure levels of this important pro-inflammatory cytokine in the blood could be a crucial step toward diagnosing disease severity and provide a rationale for selecting patients most likely to benefit from antibody therapy,” noted Paul Rubin, M.D., president and CEO of Critical Therapeutics.

The company is developing antibodies to HMGB1 in collaboration with MedImmune, Inc. (Gaithersburg, MD, USA). To date, the collaboration has generated several antibodies and is in the process of selecting a candidate for clinical development. The company believes that, unlike other inflammatory mediators, such as interlekin-1 and tumor necrosis factor (TNF)-alpha, HMGB1 is released much later in the inflammatory cascade and persists at elevated levels for a longer period of time.

"The addition of HMGB1 puts us in a leading position with proprietary markers for the diagnosis and management of sepsis,” said Mike Whelan, vice president of Beckman Coulter's immunoassays and nucleic acid testing business.




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