Ascend Therapeutics, Inc. Files Patent Applications Covering Two Clinical Indications With Topical 4-OHT gel
February 26, 2003 - New York City, NY - At the BIO CEO and Investor Conference in NYC today, ASCEND Therapeutics, Inc. announced today that it filed two patent applications for 4-hydroxy tamoxifen (4-OHT) gel or TAMOGEL™ covering two clinical indications currently in Phase II development.
Mastalgia or Cyclical Breast Pain
The first patent application covers the treatment of mastalgia, or cyclical breast pain, with TamoGel™. Cyclic breast pain is the most common breast problem for which women consult their general medical practitioners. Its severity varies, but mastalgia can be intense and can interfere with normal daily activities.
There is no clear "standard of care" in the U.S. to treat cyclic breast pain. The cancer drug, tamoxifen, has shown promise for treating cyclic breast pain. In several reported studies, orally administered tamoxifen reduced pain in 71-90 percent of patients with moderate-to-severe mastalgia. As an estrogen-receptor agonist and antagonist, tamoxifen provokes a wide range of systemic side effects such as increased risk of endometrial cancer, endometrial hyperplasia, polyps, deep vein thrombosis and pulmonary embolism, as well as hot flashes and other menopausal symptoms in younger women.
Medical practitioners have experimented with other drug treatments like oral contraceptives, hormones such as danazol, estrogen blockers and bromocriptine. These medications are often viewed as a last resort because of their known toxicities.
Jay Bua, ASCEND's CEO commented, "A topical treatment for cyclic breast pain that effectively reduces pain while provoking few systemic side effects would offer significant benefits to patients. We are currently conducting a Phase II trial to evaluate the effect of the topical 4-OHT gel for breast pain in conjunction with our partner, Besins International, the largest manufacturer of hydroalcoholic gels."
Breast Density
The second patent application covers TamoGel™ for breast density. TamoGel™ for breast density relates to improvements in mammographic sensitivity and to reduction in breast cancer risks. Dense breast tissue carries two important health implications. First, it is a predictor of breast cancer risk. Second, it affects mammographic accuracy. This is critical because of current widespread reliance on mammography for cancer detection.
Approximately one-third of breast cancer occurs in premenopausal women. Premenopausal women are known to have greater breast density than older women. In a mammography x-ray, dense breast tissue and cancer tumors both appear as white masses, making a mammogram difficult to read.
Mr. Bua continued, "Our current Phase II study addresses the potential for mammography to be a better screening tool by studying whether a topical gel can reduce breast density and allow mammograms to be read more easily."
About ASCEND Therapeutics, Inc.
Based in Herndon, Virginia, ASCEND Therapeutics, Inc. develops and intends to market therapeutics using platform technologies for alternative delivery. The Company's drug candidates are focused on unmet medical needs, particularly in the areas of chronic therapeutic use, where using alternative delivery systems can provide greater patient compliance and therapeutic benefit.
ASCEND's initial product pipeline derives from Besins International, a successful international pharmaceutical company. Besins is privately-held, headquartered in Belgium, with revenue of approximately $100 million and 300 employees.