LAKE BLUFF, Illinois — NeoPharm Inc. has filed an investigational new drug application with the U.S. Food and Drug Administration for a drug that would treat idiopathic pulmonary fibrosis, a deadly lung disease.
The submission of the application is “a major milestone” for NeoPharm, Chief Executive Dr. Aquilur Rahman said in a statement.
The company plans to start a Phase I clinical study in which the drug, now called IL13-PE, will be administered into patients’ lungs as an inhaled, aerosolized liquid. NeoPharm expects to conduct the study at six to eight sites with 32 patients. The study’s objective will be to assess the safety and the maximum-tolerated dose of the drug, along with its efficacy in patients with advanced idiopathic pulmonary fibrosis, according to the statement.
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NeoPharm has thus far performed studies of the drug in animals and human tissue in test tubes.
Pulmonary fibrosis is a serious disease that causes progressive scarring of the lung tissue. The scarring leads to a stiffening of the lungs and makes breathing difficult. The most common symptoms are shortness of breath and a dry cough. There’s no cure, but a lung transplant may be an option for those suffering from the disease.
NeoPharm, founded in 1990 as OncoMed Inc., has somewhat of a star-crossed history. While it has multiple drugs in various stages of clinical development, it has yet to bring a drug to market. It’s currently working on drugs to treat breast and ovarian cancer and brain disease.
The company voluntarily delisted from Nasdaq a year ago and is now listed on the over-the-counter exchange. Its stock, which once traded as high as $12 a share, now hovers around 30 cents. Its share price has steadily declined since 2006, when the firm announced disappointing results from a clinical trial of a once-promising brain cancer drug, according to Crain’s Chicago Business.
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In the three combined years of 2005 to 2007, NeoPharm posted a combined operating loss of about $90 million. It did not file a year-end financial report for 2008.
In 2007, it began a reorganization plan that included hiring a new management team, reducing its cash consumption and “streamlining” its organization.
