FOR IMMEDIATE RELEASE

 

RESEARCH STUDY OF A TOPICAL GEL FOR CYCLIC BREAST PAIN

Recruitment of Women for Clinical Trials in Two U.S. Cities Underway

 

June 18, 2003 -- Charlottesville, VA and New York, NY – According to leading breast disorder specialists, nearly half of all women will at some point in their lives seek medical attention for a very common benign breast disorder called cyclic breast pain. Now, two clinical sites in Charlottesville, VA and New York, NY are recruiting for a Phase II clinical trial of a potential new drug for this disorder.

Cyclic breast pain may be hormone related and is tied closely to the menstrual cycle. Women who suffer from the disorder experience symptoms varying from tenderness and pain to lumpiness and swelling of the breasts. 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 jobs.

Current treatment options are few, often lack scientific validation or have undesirable side effects. Over the years, physicians have recommended vitamin E or evening primrose oil, or have advised their patients to eliminate caffeine from their diets, though little scientific data exist to support these treatment options.

Currently, the only approved drug on the market for cyclic breast pain is Danazol, an androgen, which may cause unwanted side effects such as facial hair growth, acne and weight gain. “When I tell my patients about the side effects of Danazol, they all decide against it as a treatment option,” noted Dr. Jennifer Harvey, a breast disorder specialist from the University of Virginia. “Finding a safe and effective treatment for cyclic breast pain is very exciting, as current treatment options are very limited.”

A clinical trial studying the effect of an investigational drug formulation for cyclic breast pain is currently underway at study sites in the United States and in Europe. This Phase II, placebo-controlled clinical trial will enroll 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 4-Hydroxytamoxifen hydroalcoholic gel, TAMOGEL™, on the reduction of cyclic breast pain.

As the occurrence of cyclic breast pain is thought to be linked to a woman’s monthly fluctuations in estrogen levels, it is theorized that TAMOGEL™ may mitigate the disorder by limiting the effects of estrogen in the breast tissue. TAMOGEL™ 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™ is distributed systemically throughout the body.

TAMOGEL™ is formulated using a derivative of the drug tamoxifen. In previous trials, 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. Tamoxifen, however, is also associated with certain significant side effects. If effective, TAMOGEL™ 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 reducing the risk of many of the usual side effects associated with the related drug, tamoxifen.

Study Requirements
Women under age 45 with moderate to severe monthly breast pain and regular menstrual cycles, and who are not pregnant, breast-feeding, or using hormonal contraceptives are eligible for the study.

Study Sites in the U.S.
The TAMOGEL™ study is being conducted at two clinical sites in the U.S., the University of Virginia in Charlottesville, Virginia and Columbia University in New York, New York. Women who live in the Charlottesville area and are interested should call 434-982-3639. Women who live in the New York City area should call 212-305-0947.

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. Besins is privately held and headquartered in Belgium.

 

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Barbara Askjaer, 781-599-4774, Barbara@lavoiegroup.com or

LaVoie Strategic Communications Group, Inc.