| IPF - Idiopathic Pulmonary Fibrosis |
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The Company has licensed IL13-PE38 from NIH, FDA, and University of Michigan as a potential therapeutic agent for the treatment of idiopathic pulmonary fibrosis (IPF) and asthma. IPF may result from a malfunctioning immune system. Repeated immune-related damage and scarring destroys the elasticity of the lungs, compromising the patients' ability to breathe. Cells initiating the immune response to the lungs over-express IL-13 receptors. Selective destruction of cells presenting IL-13 receptors reduces further damage and improves lung function in animal disease models of idiopathic pulmonary fibrosis. IPF is the most deadly disease of the lungs in humans with very high morbidity and no proven effective treatment. The Company's collaborators have completed extensive preclinical studies in animal models to evaluate the control and reversal of pulmonary fibrosis with this agent. The following slide shows reduced pulmonary fibrosis in mouse studies after treatment with IL13-PE38.
NeoPharm has also completed a two-week inhalation toxicology study in non-human primates performed by the Lovelace Respiratory Research Institute. This study was designed to provide a detailed safety evaluation of the product in non-human primates through nebulization and to fully characterize the distribution in the lungs and other tissues and to identify any toxicity related to any organ with IL-13 inhalation. The physio-chemical properties of the nebulized product were extensively studied to predict its distribution into the lungs. Based on the results from the studies that NeoPharm has performed in animals and in ex-vivo human tissue, NeoPharm has filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for IL13-PE38 for the treatment of IPF. In this Phase I clinical study, the IL13-PE38 will be administered into the lungs as an inhaled, aerosolized liquid. Six doses of the drug with sequential increment will be administered in a total of 32 patients. The objective of the study is to assess the safety and the maximum tolerated dose, along with efficacy in patients with advanced IPF. NeoPharm anticipates conducting the Phase I study through a collaboration with IPFnet, a collaborative group of clinical sites formed under the auspices of National Heart, Lung and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH). It is expected that six to eight sites will be performing the clinical studies with the coordinating center role being assumed by the Duke Clinical Research Institute (DCRI). NeoPharm has also filed an application with the Office of Orphan Products Development of the U.S. FDA to have Orphan Drug Designation granted to IL13-PE38 for the treatment of idiopathic pulmonary fibrosis. |
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