News Release

June 21, 2004

Contact: Kristina Goodnough, 860-679-3700

Research Shows Promise for New Drug to Prevent Mouth Sores in Cancer Patients

Study Medication Wins Fast Track Status from FDA

FARMINGTON, CONN. - Painful chemotherapy- and radiation-induced mouth sores were significantly reduced by a new medication, according to the results of a Phase III clinical trial announced this month.

“The study medication reduced the incidence of the painful sores, known as oral mucositis, by 22 percent,” says Douglas Peterson, DMD, PhD., professor of oral diagnosis at the University of Connecticut Health Center and lead investigator of the study for the developer Aesgen Inc of Princeton, N.J. The study was presented at the 40th annual meeting of the American Society of Clinical Oncology in New Orleans as a late-breaking abstract. It was one of 23 such abstracts selected from several thousand for presentation at the meeting.

Oral mucositis, which afflicts about 400,000 cancer patients every year in the United States alone, can cause a number of significant problems. In addition to considerable mouth discomfort, the condition can seriously affect the quality of life of the patient and family caregivers; and it can interfere with nutritional support during cancer treatment. Oral mucositis can pose a major risk of infection that spreads throughout the body in patients with low blood counts, resulting in considerable morbidity or death. “They can also be one of the main reasons why patients suspend chemotherapy or head and neck radiation that may be saving or prolonging their lives,” says Peterson. “Some cancer patients who suffer from oral mucositis must be hospitalized and fed intravenously and given opiates or narcotics to control their mouth pain. Treatment for the mouth sores in the critically ill can cost as much as $40,000 for every patient. It can be a very expensive toxicity to manage,” says Peterson.

The study followed 2,084 women with breast cancer who received three cycles of anthracycline-based chemotherapy. During the first cycle of treatment, none of the women received the study medication, and nearly 16 percent, or 326 women, experienced clinically significant oral mucositis. Those 326 women were then divided into two groups. One group received the medication during the second cycle of chemotherapy and placebo during the third cycle. The other group received placebo during the second cycle and the medication during the third cycle.

“We found that the medication significantly reduced the mouth sores during the chemotherapy cycle in which it was given. We also found a significant protective effect that carried over into the next cycle,” says Peterson. “That outcome was a surprise and represents an important new direction for the research and patient treatment, namely, consideration of pretreatment and longer term treatment to prevent oral mucositis.”

The drug (AES-14, Saforis™) consists of a proprietary system that enhances the uptake of a beneficial amino acid by 100-fold into the cells that make up the lining of the mouth. The amino acid occurs naturally in the body and is depleted in cancer patients undergoing chemotherapy. High levels of the amino acid help the lining of the mouth recover from and repair the side effects of cancer treatment. Because it is given orally in the form of a liquid medication, it is applied directly to the tissue at risk. “You just swish it around in your mouth for 30 seconds and swallow it, three times a day. There are no needles involved. It’s very easy to use and there were no noticeable side effects,” says Peterson.

The medication has been given fast track status by the Food and Drug Administration, and the company will submit an application to develop the drug by the end of the year, says Peterson.

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