PROMETIC RECEIVES RARE PEDIATRIC DISEASE DESIGNATION FROM U.S. FDA FOR ITS INTER-ALPHA-INHIBITOR-PROTEINS
- Rare Pediatric Disease Designation granted for the treatment of patients with necrotizing enterocolitis (NEC)
- NEC accounts for approximately 19% of the US’s annual neonatal medical expenditures as well as an estimated $5 Billion in annual hospitalization costs in the US
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LAVAL, QUEBEC, CANADA, – March 5, 2018 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“Prometic”) today announced that the U.S Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation to its Inter-Alpha-Inhibitor-Proteins (“IaIp”) for the treatment of Necrotizing Enterocolitis (“NEC”). In addition to the Rare Pediatric Disease Designation, IAIP has also been granted an Orphan Drug Designation by the FDA.
“This is the second pediatric designation which our plasma-derived therapeutics have received from the FDA, demonstrating the capacity of our plasma purification platform to generate a variety of drug candidates targeting unmet medical needs for children with rare diseases,” said Mr. Pierre Laurin, President and Chief Executive Officer of Prometic. “The combination of pediatric and orphan drug designations provides us with valuable commercial incentives to continue expanding our pipeline of orphan drugs. We look forward to working closely with the FDA to bring this innovative therapy to pediatric patients. The costs associated with this clinical program will not impact our FY2018.”
IaIp are endogenous proteins that control excessive inflammatory responses to toxins, infectious organisms, tissue and organ damage. An inverse correlation between IaIp levels in blood plasma and disease severity / mortality has been demonstrated in humans with sepsis. In a gold-standard animal model proven to emulate NEC in humans, the supplementation of IaIp significantly increased the study subjects’ survival rates.
The FDA grants Rare Pediatric Disease Designations for serious or life-threatening diseases wherein the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents. If and when approved, Prometic’s IaIp replacement therapy could be eligible to receive a rare pediatric disease priority review voucher.
NEC is the most commonly acquired gastrointestinal disease diagnosed in premature neonates and is one of the leading causes of death in neonatal intensive care units. The economic cost of NEC is high, accounting for approximately 19% of neonatal expenditures and an estimated $5 billion per year for hospitalizations in the United States alone. Even when surgery can be avoided, the average cost of hospitalization has been estimated at around $73,000, with a length of stay exceeding 22 days longer than that for other premature infants. However, if surgical care is required, there is an average additional cost of approximately $186,000, and infants require a length of stay 60 days longer than other premature infants.
About Inter-Alpha-Inhibitor-Proteins (IaIp)
Inter-alpha inhibitor proteins (IaIp) are serine proteases inhibitors that modulate endogenous protease activity. Severe sepsis results in reduced IaIp with the loss of protease inhibitory activity. Treatment with IaIp is protective in numerous preclinical sepsis models
About Necrotizing Enterocolitis
Necrotizing enterocolitis (NEC) is a devastating inflammatory bowel condition that affects predominantly premature infants. NEC can ultimately destroy the wall of the bowel (intestine) and lead to perforation of the intestine and spillage of stool into the infant’s abdomen, which can result in an overwhelming infection and death. The cause of NEC is not well understood but appears to involve bacteria, injury to the bowel lining, inadequate oxygen supply to the bowel, and an abnormal immune response. Overall, NEC affects an estimated 8,000-12,000 live births each year in the USA. The disease has been reported to affect about 11 percent of very low birthweight infants born before 29 weeks of age. Mortality rates are high, and range from about 15% to 30%.'
Jim
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