FDA response on IL 13-PE expected on February 4, 2010 (NASDAQ:NEOL)

On January 4, 2010, NeoPharm, Inc. (NASDAQ:NEOL.PK), a biopharmaceutical company that discovers, develops and markets drugs for treating patients suffering from cancer and other life threatening diseases, disclosed that it has submitted an investigational new drug application (IND) to the FDA. The application was submitted for the IL 13-PE38QQR (also called IL 13-PE for short), a drug that has been discovered and developed by NeoPharm. The drug will be used for treating patients suffering from Idiopathic Pulmonary Fibrosis (IPF). Once an investigation new drug application is submitted, it takes about 30 days for the FDA to review the application and give its response. The response usually includes information on the clinical trials the company is planning to conduct for the drug. We expects to get the FDA’s response on the drug IL 13-PE38QQR on or around February 4, 2010.

Idiopathic Pulmonary Fibriosis is a disease that affects the lungs of humans. According to NeoPharm, out of all the lung diseases, IPF causes the highest number of deaths. In addition, IPF has an extremely high degree of morbidity (that is, the disease extremely deteriorates the conditions of the patients and is very less likely to improve).

Many pharmaceutical companies in both US and abroad have tried to discover treatments for IPF but in vain. There is still no drug in the market that has been approved by the FDA for treating patients with IPF. As a result, there is a great demand for a cure for this fatal medical condition. NeoPharm understood the need and had worked hard to develop a substantial drug for IPF. The result is IL 13-PE.

NeoPharm has conducted several studies before to measure the safety and the effectiveness of the IL 13-PE. The studies have been down in both ex-vivo tissues of humans and in animals. The results from the studies have been favorable so far. For instance, the study has demonstrated that the receptors for IL13 (interleukin 13) seem to be “over expressed” a lot in pulmonary fibroblasts in cases of patients suffering from IPF. IL 13-PE – which is the recombinant protein in this case – can provide “selective cytotoxicity” to these receptors of IL 13-PE in fibroblasts. As a result, IL 13-PE shows that it may capable of curing IPF in humans.

As many as 32 patients will be participating in the Phase 1 clinical trial. The IL 13-PE will be provided to the patients in aerosolized liquid form and the patients would then have to inhale the drug. The dose of the drug will increase sequentially. In total, there will be six doses. This would help to determine the maximum dose that can be tolerated by the patients and the safety of using the drug. In addition, the trial will measure the effectiveness of using the drug in cases of patients suffering from advanced forms of Idiopathic Pulmonary Fibriosis.

Dr. Aquilur Rahman, who is the Chief Executive Officer and also the President of NeoPharm Inc. said:

“The submission of this IND is a major milestone for the Company. We anticipate conducting this study through 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. 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.”