Claragen Explores How Uteroglobin Can Prevent Neonatal Lung Disease

June 02, 1997

COLLEGE PARK, Md. -- June 2, 1997 -- ClaraGen Inc. a biopharmaceutical company founded in 1996, is conducting research focusing on uteroglobin (UG), a human protein which plays an important role in preventing inflammatory and fibrotic diseases.

The company has signed a Cooperative Research and Development Agreement
NIH researchers also have discovered a novel physiological role for UG in mice, raising the possibility that UG may be essential in preventing kidney fibrosis in human beings. The results of the NIH study are published in the May 30 issue of Science, the weekly journal of the American Association for the Advancement of Science.

Dr. Anil B. Mukherjee and his colleagues at NICHD, NIH explored the relationship of UG and kidney disease by comparing kidney function in mice with normal levels of UG and mice that had been genetically engineered to be UG-deficient. The "knockout," or UG-deficient mice, developed blockages in their kidneys, which inhibited the kidney's ability to filter blood and remove impurities.

The blockages were created by deposits of fibronectin, another protein which normally circulates in the blood and is a major component in the formation of blood clots and the wound healing process. In the control group of mice, UG bound to fibronectin, preventing fibronectin from accumulating and blocking kidney function.

But in the "knockout" mice, the absence of UG resulted in deposits of fibronectin and led to fibrosis in the kidneys, causing lethal renal failure. These findings indicate that UG may play a similar role in controlling fibroses in the human kidneys, as well as in other human organs.

Neonatal BPD

Severely premature infants lack adequate amounts of UG, because the protein begins to appear in significant concentrations in the fetal lung only during the last few weeks of gestation. The UG deficiency results in inflammation and fibrosis of lung tissue, which inhibits respiration.

About 90,000 newborn infants in the United States are at risk for neonatal BPD annually, of whom about 13,000 will develop the condition, and 4,700 will die. Many of the surviving infants will suffer lifelong disability. The cost of acute treatment for neonatal BPD is extremely high -- about $200,000 per patient, according to a recent study-- and the need for a preventive treatment is widely recognized.

ClaraGen's focus on uteroglobin

Uteroglobin (UG), or CC10, is a protein which has a number of biological functions in the human body. In the lungs, UG plays an important role in controlling both inflammation and the formation of damaging fibrous tissue. It also appears to play a similar role outside the lungs, not only controlling inflammation, but also regulating processes that maintain a normal and healthy state within other organs

ClaraGen Inc. is a biopharmaceutical company focusing on the commercialization of UG in inflammatory and fibrotic human diseases. The company has identified a number of medical conditions in which human UG is present in inadequate amounts or is absent altogether. ClaraGen is developing techniques for producing a genetically-engineered form of UG that would replenish this needed human protein.

ClaraGen is initially pursuing research to determine how recombinant human UG can be used in the prevention of neonatal BPD. The company plans to explore other applications for recombinant UG.

ClaraGen was founded in 1996 and is based in College Park, Maryland.

Mark Zimmer
ClaraGen, Inc.
335 Paint Branch Rd.
College Park, MD 20742
(301) 314-7805

Russell-Welsh Public Relations

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