New research on the efficacy of Saforis could mean a significant improvement in the health of patients undergoing chemotherapy treatments.

Saforis, a product of Aesgen, is an oral suspension currently in Phase III clinical trials for oral mucositis. A common and painful side effect of chemotherapy treatments, oral mucositis is damage to the lining of the throat and mouth, damage that can become so severe that patients may have trouble eating and drinking. Saforis recently received fast-track status from the FDA.

Approximately 40-80% of patients receiving chemotherapy suffer from the condition, adding up to nearly 400,000 cases in the U.S. every year. The incidence depends on the type of chemotherapeutic regimen, including its intensity. Saforis is designed to alleviate damage to the soft tissues of the oral cavity by providing a unique formulation to the cells of the mouth and throat using a proprietary delivery system.

"In its [L-glutamine's] native form, we faced some challenges at the molecular level," explained Dr. Douglas E. Peterson during a May 31, 2003 American Society of Clinical Oncology (ASCO) presentation titled "Phase III Study: AES-14 in Chemotherapy Patients at Risk for Mucositis. Dr. Peterson is currently Professor and Head, Department of Oral Diagnosis, School of Dental Medicine as well as an Associate Director in the Cancer Center at the University of Connecticut Health Center. Dr. Peterson reported that L- glutamine is poorly soluble, chemically labile and is rapidly metabolized. Until now, delivery of L-glutamine to oral mucosa at therapeutically effective levels had not been proven possible.

Evidence reported at the recent ASCO presentation, however, suggests that Saforis and its unique delivery system may be able to effectively overcome these challenges. Dr. Peterson outlined study results that suggest Saforis can provide a potential 20% reduction in moderate to severe chemotherapy- associated oral mucositis, and a 10% increase in number of patients who develop no oral mucositis.

Aesgen develops, markets and licenses innovative products based on the Aesgen Drug Delivery System -- an innovative system that will introduce a new generation of medicines focused on the treatment and prevention of disease.