Neonatal Jaundice drug awarded patent
synthetic method of preperation for a new drug being developed for
the treatment of jaundice in newborns.
The new drug, Stanate, is in late stage development being studied for the treatment of neonatal jaundice and prevention of kernicterus, a form of cerebral palsy. Kernicterus is attributed to high levels of bilirubin, a by-product of heme metabolism. Bilirubin is a bile pigment, which is normally eliminated from the body after conversion into a water-soluble form by the liver.
Stanate's mechanism of action specifically inhibits the enzyme that blocks the conversion of heme into bilirubin. Treatment would be over a number of days until the baby's liver has matured and facilitated the excretion of bilirubin.
Newborns often temporarily lack the necessary liver maturity to eliminate bilirubin and require several days to develop this capability. Neonatal jaundice is normally a transient phenomenon, but left untreated in more severe forms, can result in irreversible brain damage.
The patent grants exclusive rights to WellSpring for a novel method of synthesis. The process involves fewer steps, increased yields and lower costs. Foreign patent equivalents have also been filed.
Tin (IV) mesoporphyrin IX dichloride (stannsoporfin) is the chemical compound being investigated for use as a medicament in the treatment of infant jaundice. Stannsoporfin is also known to inhibit heme metabolism in mammals, to control the rate of tryptophan metabolism in mammals, and to increase the rate at which heme is excreted by mammals.
A second patent for water-soluble stannsoporfin analogs (a composition of matter patent) has also been submitted. This second patent is under regulatory review and has been previously published. The new stannsoporfin analogs covered by this patent may be suitable for either oral or parenteral administration.
The use of Stanate may prevent the need for other medical intervention and may protect the infant from the possibility of brain damage. Stanate is normally given by injection.
Jaundice is most often treated with phototherapy. This involves placing the baby on a warmer beneath special lights. These lights are able to penetrate a baby's skin and affect the bilirubin within the child. The light changes bilirubin into lumirubin, which is easily handled by the baby's body.
The national incidence of kernicterus and cerebral palsy has been reported to be on the rise. At least 60 to 70 per cent of term infants will become visibly jaundiced, meaning their serum bilirubin levels will exceed 5 to 7 mg/dL Jaundice is the most frequent reason for readmission to hospitals in the first 2 weeks of life.
