Source: DGNews  |  Posted 9 years ago

PRINCETON, NJ -- February 4, 2003 -- Aesgen, Inc., a privately held specialty pharmaceutical company, announced today that the United States Food and Drug Administration (FDA) granted Fast Track designation to the Company's investigational new drug, Aesgen-14 (AES-14) for oral mucositis associated with cancer chemotherapy. Fast Track designation is intended to expedite the regulatory review and approval process for a product and claim that addresses a significant unmet medical need. The Company is in Phase III clinical trials in the U.S. and overseas with AES-14 treatment during chemotherapy for breast cancer. Aesgen plans to submit a New Drug Application (NDA) to the FDA in 2003 under this Fast Track designation.

Dr. Edward Shinal, President and Chief Operating Officer of Aesgen, Inc., stated, "Currently, there are no approved treatments for chemotherapy induced mucositis and we believe that AES-14 has the potential to significantly reduce the incidence and severity of this serious medical condition. AES-14 represents a new approach in oral mucositis treatment and we are very excited about receiving Fast Track designation from the FDA."

AES-14 is a proprietary mouth rinse suspension that is used two or three times per day during chemotherapy. AES-14 has been effective in randomized placebo controlled clinical trials at significantly reducing the emergence, severity, and duration of mucositis. In granting the Fast Track designation, the FDA recognizes that oral mucositis is a serious illness that needs to be addressed expeditiously.

About Oral Mucositis
Oral mucositis is a common, debilitating side effect of cancer treatment occurring in approximately 40 percent of patients receiving chemotherapy and radiation. Oral mucositis is inflammation of the moist tissue lining the mouth and ranges from redness to severe ulceration. Symptoms of mucositis vary from pain and discomfort to an inability to take food or fluids. Mucositis may also limit a patient's ability to tolerate either chemotherapy or radiation, and may be so severe as to delay treatment, limiting the effectiveness of the cancer therapy. Patients with damage to the lining of the mouth and a reduced immunity resulting from chemotherapy and radiation are also prone to opportunistic mouth infections. The use of morphine or other narcotic analgesics are indicated when severe pain accompanies the mucositis.

About Aesgen
Aesgen, Inc. is a privately owned specialty pharmaceutical company founded in 1994 by the Mayo Foundation for Education and Research and aaiPharma (Nasdaq: AAII), and whose other major investors include Medical Innovation Partners, Noro-Moseley Partners, MOVA Pharmaceutical Corp., Waters Enterprises and The Wakefield Group. Aesgen is focused on developing pharmaceutical products resulting from their cancer research collaborations, and in the specialized delivery of peptides, proteins and small molecules for critical care.

This press release includes statements that may constitute "forward- looking" statements. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this press release.

SOURCE: Aesgen, Inc.