Company Gets Fast Track for Drug to Treat Oral Mucositis

December 15, 2003

(Company press release.)

New Treatment Offers Hope For Cancer Patients

12/12/2003

Source: Aesgen Inc.

New research on the efficacy of Saforis could mean a significant

improvement in the health of patients undergoing chemotherapy

treatments.

Saforis, a product of Princeton-based Aesgen Inc., 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. E. 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. 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. 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. 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. To listen to Dr. 's entire ASCO presentation,

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