Bob, so what is the status of this?>>>“This pilot study is the first in a series of potential probe studies XOMA is considering to
explore various indications for NEUPREX®,” said John L. Castello, XOMA’s chairman,
president and chief executive officer. “We believe NEUPREX® has established a promising
safety and activity profile in clinical trials involving over 2000 patients in a variety of
indications. We’re pleased that Children’s Medical Center Dallas physicians also believe that it
could potentially be a beneficial treatment for pediatric patients undergoing extensive surgical
interventions and look forward to reviewing the results following the study’s completion."
About Congenital Heart Disease, Open Heart Surgery (OHS) and Cardiopulmonary
Bypass (CPB)
Every year, an estimated 35,000 babies are born with some form of congenital heart disease.
More than twice as many children die from congenital heart disease in the U.S. each year
than from childhood cancers. Approximately one-third of children born with congenital heart
disease will require surgery in the first year of life. The majority, more than 6,000 infants each
year, will require complex open heart surgery (OHS) which necessitates the use of
cardiopulmonary bypass (CPB), a heart-lung bypass machine.
During CPB, the heart-lung machine takes over the functions of the heart and lungs (which
have been cooled down and stopped), allowing a surgeon to operate on the heart while the
machine sustains circulation. However, CPB itself poses significant risks which are particularly
prominent in pediatric patients. CPB induces a systemic inflammatory response associated
with increasing blood levels of endotoxin and causes damage to children’s immature organ
systems including the heart, lungs, kidneys and brain. The incidence of complications
associated with pediatric OHS patients undergoing CPB ranges from 25-60 percent, with the
inflammatory response to CPB causing a prolonged need for mechanical ventilation and
heart medications, and additionally bleeding complications and multiple organ failure. All of
these post-operative complications can impair patient recovery, resulting in extended hospital
stays and increased medical expenses.<<<<<<<< |
