NeoPharm, Inc, has filed an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is the most deadly disease of the lungs in humans with very high morbidity. There is currently no proven effective treatment for the cure of this disease.
The studies that NeoPharm has performed in animals and in ex-vivo human tissue have shown that the receptors for interleukin 13 (IL13) are significantly 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.
In this phase-I clinical study, the IL13-PE 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.
Dr Aquilur Rahman, president and CEO commented, "The submission of this IND is a major milestone for the company. We anticipate conducting this 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 these clinical studies with the coordinating center role being assumed by the Duke Clinical Research Institute (DCRI).” Dr Rahman further commented, "We are fortunate to have these prestigious centers interested in our clinical trials to hopefully make a difference in the survival and quality of life for these extremely sick patients".
NeoPharm, based in Lake Bluff, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer and other drugs for therapeutic applications.