Pharma Inc, a Houston-based pharmaceutical company developing a
medical discovery made at The University of Texas Health Science Center
at Houston (UTHealth) Medical School, has been awarded $565,449 for the
first year of a potential two-year $1,118,398 grant to conduct research
designed to enhance a treatment for premature babies with a common
congenital heart defect.
ductus arteriosus (PDA) is a leading cause of death in low birth
weight premature infants. It can occur when a heart vessel that normally
closes on its own after birth remains open. It can affect about half of
the very low birth weight infants. The grant is from the Eunice
Kennedy Shriver National Institute of Child Health & Human Development.
A major breakthrough in the treatment for PDA occurred with the
discovery that a non-steroidal anti-inflammatory drug (NSAID) named
indomethacin speeds the closure process. It is the standard of care in
many hospitals, often administered over a two- or three-day period and
given intravenously to babies with PDA.
The discovery allowed doctors to give parents a less invasive and safer
alternative to surgery for newborns with PDA.
However, this medical treatment is associated with some health risks.
Indomethacin can be hard on the gastrointestinal tract (GI) of newborns,
much like aspirin can damage the GI tracts of adults, said J.
Marc Rhoads, M.D., who is advising the PLx Pharma team and is
director of the Division of Gastroenterology and Nutrition in the
Department of Pediatrics at the UTHealth Medical School.
"For example, about 3 percent of very low birth weight infants will
develop spontaneous intestinal perforation, and the risk is
greater if they have been treated with indomethacin. This is why it
is important for physicians and parents to weigh the pros and cons of
treatments," Rhoads said.
PLx Pharma and UTHealth are working to reduce the GI toxicity of NSAIDs
by formulating this family of drugs with a natural lipid named
phosphatidylcholine. The scientists believe this formulation could
mitigate problems associated with indomethacin PDA treatment.
The plan is to test a phosphatidylcholine-enriched version of
indomethacin in a preclinical model of PDA, according to Lenard
Lichtenberger, Ph.D., and Elizabeth
Dial, Ph.D., who are leading this study and are on the faculty of
the Department of Integrative Biology and Pharmacology at the UTHealth
"This product is being developed to meet a serious unmet need for this
compelling patient population," said Ron Zimmerman, president of PLx
Lichtenberger pioneered the use of phosphatidylcholine as a way to make
NSAIDs safer for the millions in the United States who count on this
family of drugs for pain relief and to protect against heart disease.
Clinical trials using aspirin and ibuprofen formulated with this
technology have been successful and suggest a 70 percent reduction in
the risk of upper GI ulcers.