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guidelines developed for use in treating hyperbilirubinemia. The

religious grounds) were spared brain damage by use of the drug.

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The multicenter clinical trial was conducted by leading pediatrician/neonatologist experts with clinical expertise in treating bilirubin disorders and jaundice. All are members of the American Academy of Pediatrics and other learned medical societies. The study investigators were: Dr. Vinod K. Bhutani, lead investigator and Professor of Pediatrics and Neonatology at Pennsylvania Hospital, Philadelphia, PA; Dr. Avery A. Fanaroff, Cleveland, OH; Dr. Thomas Hegyi, New Brunswick, NJ; Dr. M. Jeffrey Maisels, Detroit, MI; Dr. Linda Meloy, Richmond, VA; and Dr. Ronald Poland, Albuquerque, NM. The group was called the ICTERx Working Group. The study results were presented by Dr. Bhutani on behalf of the clinical trial participants.

Jaundice in babies is the result of a temporary accumulation of the bile pigment bilirubin. It is the most common cause of neonatal hospital readmissions accounting for about 60% of same. Bilirubin is a neurotoxin and high levels, left untreated in babies, it can result in permanent brain damage or "Kernicterus," a lifelong disability resembling cerebral palsy and a disorder that requires constant medical supervision. Babies with kernicterus and proper medical care can live long lives. It has been estimated that each kernicterus child will require between $10 and $25 million in medical care over the course of their lifetimes. Stanate(TM) is a new investigational drug which temporarily inhibits the formation of bilirubin in babies and prevents the development of kernicterus.

and before jaundice is Nike Sportswear Tech Fleece Trousers

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new guidelines for treatment of neonates with hyperbilirubinemia.

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Blood transfusions in newborns are not without risk and show a 10%

combined morbidity and mortality rate. Stanate(TM) use in these

Sub Committee on Neonatal Jaundice of the American Academy of

In other clinical reports at the San Francisco meeting, Dr. M.

Dr. Maisels presented these new guidelines at the Audrey K. Brown

Tel: (732) 938 5885

Other Clinical Reports:

published previously. The revised guidelines will be published in

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Stanate(TM) was compared to placebo in the clinical trial reported by Dr. Bhutani. The trial participants used an age specific nomogram, also termed the "Bhutani Nomogram," to select babies for enrollment into the randomized clinical trial. This nomogram is predictive of severe jaundice in babies based on bilirubin levels determined shortly after birth Nike Jacket Winter

The results of this pivotal clinical trial demonstrated that the use of Stanate(TM) in babies with hyperbilirubinemia resulted in statistically significantly lower blood bilirubin levels, lower body load of bilirubin, and fewer and shorter uses of phototherapy compared with placebo. No significant adverse events were reported in the Stanate(TM) treated children.

rights to Stanate(TM) from Rockefeller University, New York, NY.

of care for hyperbilirubinemia for prevention of kernicterus.

babies eliminated all need for an exchange transfusion.

Pediatrics. These guidelines will replace older outdated guidelines

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In a poster presentation, six Jehovah Witness babies who received

the July issue of the journal Pediatrics and will become the standard

Kernicterus Symposium of the PAS. Dr. Maisels is a member of the

InfaCare is continuing to pursue marketing clearance for Stanate(TM) and is cooperating with the Food and Drug Administration in answering all questions regarding its planned New Drug Application.

established. This approach allows the introduction of therapeutic interventions before severe jaundice develops, including use of Stanate(TM) to inhibit further formation of bilirubin.

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Stanate(TM) in lieu of a blood transfusion (which was refused on

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1 Announces Clinical Trial Results For Nike Socks In Package Stanate New Drug Treats Jaundice In Newborns And Prevents Brain Damage ICTERx Multicenter Trial Results Presented

Jeffrey Maisels presented attendees with an initial look at new

Fax: (732) 751 9328InfaCare is a new privately held pharmaceutical company founded in 2001 by Dr. Robert A. Vukovich the firm's CEO and Chairman. Dr. Vukovich previously founded and managed Roberts Pharmaceutical Corporation of Eatontown, NJ, until its acquisition by Shire Pharmaceutical Group in 1999. He is also the founder and CEO of WellSpring Pharmaceutical Corporation of Neptune, NJ. InfaCare received its marketing rights to Stanate(TM) from WellSpring. WellSpring originally licensed worldwide Nike Sportswear Tech Fleece Red

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Bhutani Nomogram referred to above has now become a central tool in

Contact: Pat Naffin

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