ASCEND Therapeutics Announces Study Results from Phase 2 Cyclic Breast Pain Study
ASCEND Presents Results of Phase 2 Clinical Trial for Cyclic Breast Pain. Company's Transdermal 4-OHT Therapy Was Well Tolerated and Reduced Breast Pain in Clinical Trial
Herndon, Va. - May 11, 2005 - ASCEND Therapeutics, a leading research and development company of pharmaceutical transdermal therapies for the treatment of chronic conditions, today announced that researchers presented findings regarding the company's 4-hydroxytamoxifen (4-OHT) gel during the 53rd Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) at the Moscone Center in San Francisco.
A poster presentation at ACOG offered data on the safety and efficacy of ASCEND Therapeutics' 4-OHT gel in patients with menstrual-cycle related mastalgia. The Phase 2 study, which was a placebo-controlled, double-blind, dose-ranging, and randomized study, indicated that the investigational transdermal 4-OHT gel, if approved by the FDA, may represent a new way to treat cyclic breast pain, also called cyclic mastalgia.
Poster number 16 entitled "4-Hydroxytamoxifen (4-OHT) Gel for Cyclic Mastalgia in Premenopausal Women: A Phase II Trial," was presented by Dr. Robert E. Mansel of the University of Wales College of Medicine. The study showed that the transdermal application of 4 milligrams of 4-OHT in an alcohol-based gel to the breast significantly improved the signs and symptoms of cyclic breast pain. There was a significant decrease in an objective measure of cyclic breast pain compared to baseline. In addition, application of 4-OHT gel resulted in a significant reduction in pain severity as measured by a number of physician- and patient-rated scales. The study further found that 4-OHT gel is generally well-tolerated; headaches were the most common side effect, which were in general mild and similar across treatment groups. Study results indicate that menstrual cycles and menses were not disrupted over the course of the treatment period and hormonal plasma levels did not change.
"This was a very promising study," said Dr. Mansel. "if approved, ASCEND's transdermal 4-OHT gel may offer patients with cyclic mastalgia an option for the treatment of the targeted breast tissue, while avoiding side effects often associated with systemic therapies."
The poster presentation is available at http://www.ascendtherapeutics.com/about/news/ACOG-2005.pdf.
Prevalence studies indicate that 68% of premenopausal women suffer from cyclic breast pain, and up to 22%, or 8 million women in the United States, have cyclic breast pain that is moderate-to-severe in nature for two weeks or longer during their menstrual cycles. This pain disrupts ordinary daily activities, like sleep, physical activities, exercise and intimate relations, and significantly impacts quality of life. There are no approved, safe and well-tolerated treatments for this condition.
ASCEND is developing a portfolio of transdermal therapies for chronic conditions, including breast pain, based on its proprietary Enhanced Hydroalcoholic Gel (EHG™) technology.
About ASCEND Therapeutics
ASCEND Therapeutics is a biopharmaceutical company focused on the use of transdermal drug delivery technology to overcome therapeutic barriers and raise the standard of care for certain chronic conditions. For more information about ASCEND, you may visit the company's web site at www.ascendtherapeutics.com