ASCEND Therapeutics, Inc. Initiates Clinical Trial for Cyclic Mastalgia, a Breast Disorder.

Business Editors/Health/Medical Writers

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HERNDON, Va.--(BUSINESS WIRE)--April 30, 2003

ASCEND Therapeutics, Inc. announced today that it has initiated a Phase II dose-ranging clinical study of TAMOGEL(TM) (4-Hydroxytamoxifen (4-OHT) Gel) for cyclical breast pain, also called cyclic mastalgia.

Cyclic breast pain is thought to be hormone related and is tied closely to the menstrual cycle. Women who suffer from the disorder experience symptoms varying from tenderness to pain, as well as lumpiness and swelling of the breasts. Symptoms vary in severity. The majority of women who suffer from this disorder are either pre-menopausal or peri-menopausal. Cyclic breast pain can be so severe that about 10% of women with this condition experience pain that seriously impacts everyday activities like physical exercise, sexual or social activities, and even their professional careers.

The Phase II study will consist of approximately 100 healthy, pre-menopausal women with regular menstrual cycles who are not taking oral contraceptives. The primary objective is to investigate the safety and efficacy of TAMOGEL(TM) in two different doses compared with placebo on the intensity of cyclical mastalgia. The study will be conducted in four countries: United States (two centers) United Kingdom (two centers), Poland (six centers), and Czech Republic (five centers).

Jay Bua, Chief Executive Officer of ASCEND Therapeutics commented on the initiation of the clinical trial, "Cyclic breast pain is a significant burden in the daily lives of women of childbearing age in the United States. Cyclic breast pain is one of the more common health issues affecting women, given its possible link to fibrocystic breast disease. Despite this link, it is a condition not often discussed between a patient and her doctor due to the lack of education and the lack of current treatment options that have demonstrated efficacy without significant negative side effects."

ASCEND's TAMOGEL(TM) is formulated using a derivative of the drug, tamoxifen. TAMOGEL(TM) is applied directly to the surface of the breast, where the gel is absorbed locally through the skin and directly into the breast tissue. Previous studies suggest that very little TAMOGEL(TM) is distributed systemically throughout the body. (Pujol, Cancer Chemother Pharmaocol, 1995; Mauvais Jarvis, Cancer Research, 1986).

"Oral tamoxifen has been shown to reduce cyclic breast pain, as well as other benign breast diseases, including fibrocystic breast disease and the pre-cancerous conditions metaplasia and hyperplasia," noted ASCEND's Chief Medical Officer, Dana C. Hilt, M.D. "If successful, TAMOGEL(TM) may be able to reduce the occurrence and severity of cyclic breast pain, while allowing only a small amount of the drug to enter the bloodstream, thereby avoiding many of the usual side effects associated with oral tamoxifen treatment."

About Ascend Therapeutics, Inc.

Based in Herndon, Virginia, ASCEND Therapeutics, Inc. is an emerging specialty pharmaceutical company focused on discovering and developing novel pharmaceuticals for unmet medical needs utilizing its proprietary percutaneous delivery technology.

ASCEND's initial product pipeline derives from Besins International, a successful international pharmaceutical company and the world's largest manufacturer of pharmaceutical gels. Besins is privately held, headquartered in Belgium.