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news.NeoPharm has received orphan-drug designation (ODD) for IL13-PE38QQR (IL13-PE) from the Office of Orphan Products Development of the FDA, for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
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Earlier, NeoPharm had filed an investigational new drug application (IND) with the FDA for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF), on Jan 04, 2010.
The studies that NeoPharm has performed in animals and in ex-vivo human tissue have shown that the receptors for interleukin 13 (IL13) are over-expressed in pulmonary fibroblasts.
The recombinant protein, IL13-PE, has demonstrated selective cytotoxicity to the IL13 receptor-expressing fibroblasts, thereby ameliorating the histopathological evidence of IPF in animal models.
Aquilur Rahman, president and CEO of NeoPharm, said: “All the studies that NeoPharm has performed in animals and in ex vivo human tissue have shown quite promising results. We look forward to starting our clinical studies with IL13-PE as aerosolized product in humans inflicted with this devastating disease quite soon.”