FDA Grants Fast Track Designation For AES-14 For Oral Mucositis Associated With Breast Cancer Chemotherapy 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. Company announcement from Docguides.com 02/05/2003 Thanks to breastcancer.net 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. San Antonio Abstract presentation Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.