NeoPharm Submits IND For IL13-PE38QQR To FDA

NeoPharm has filed an investigational new drug application (IND) with the FDA for IL13-PE38QQR (IL13-PE), for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The company said that the studies 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.

Reportedly, in the phase I clinical study, the IL13-PE will be administered into the lungs as an inhaled, aerosolized liquid. Over 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.

Aquilur Rahman, president and CEO of NeoPharm, said: “The submission of this IND is a major milestone for the company. We anticipate conducting this study through a collaboration with IPFnet.

“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). 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.”