Advanced Life Sciences Holdings, Inc. a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced that the company has applied to the US Food and Drug Administration for orphan drug designation for ALS-886, a novel therapy to reduce and prevent tissue damage, for the treatment of Acute Respiratory Distress Syndrome (ARDS).

The FDA's US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Orphan Drug designation is awarded to compounds that offer potential therapeutic value in the treatment of rare diseases, defined as those affecting fewer than 200,000 Americans. This designation provides companies with financial and regulatory benefits such as eligibility for a special seven-year period of market exclusivity upon approval for the compound and indication with orphan designation, potential tax credits for research, potential grant funding for research and development, reduced filing fees for marketing applications, and assistance with clinical trial protocol review.

ARDS is a serious and life-threatening medical condition often caused by the inflammation and tissue damage associated with excess free radicals in the lungs. ARDS is usually treated with mechanical ventilation in the Intensive Care Unit. Currently, there are no effective therapeutic treatments for ARDS. Because infection is often the underlying cause of ARDS, appropriate antibiotic therapy is administered.

There are approximately 150,000 cases of ARDS in the United States annually and the mortality rate is approximately 50 per cent. Patients who survive ARDS will typically experience ongoing mild to moderate impairment of lung function, with poorer health-related quality of life after hospitalization compared to patients who were hospitalized without ARDS.

ALS-886 is a small molecule therapeutic that, in preclinical studies, has demonstrated efficacy in both scavenging existing free radicals and sequestering free iron. The goal of treatment with ALS-886 for ARDS will be to reduce the tissue damage brought about by the free radicals in the lungs. Previous animal toxicology studies have demonstrated the safety and benign side effect profile of ALS-886. This could prove beneficial in the use of the compound in the critical care setting.

In addition, the mild safety profile shown in animal studies supports the possibility that ALS-886 could be used as a prophylactic. That is, it could be administered to individuals who are at high risk of developing ARDS, such as patients suffering from sepsis or severe trauma, in order to prevent the underlying condition from leading to ARDS. ALS-886 may also have applicability for other conditions in which free radicals cause tissue damage, such as ischemic stroke and myocardial infarction. An open IND is in place to start phase I clinical trials.

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases.