Study of ASCEND's 4-OHT Gel Published in Journal of Clinical Oncology
Clinical Trial Evaluates Effect of Company's Investigational Transdermal Therapy on Breast Tumor Cell Proliferation
Herndon, Va. - June 2, 2005 - ASCEND Therapeutics, a leading researcher and developer of pharmaceutical transdermal therapies for the treatment of chronic conditions, today announced that researchers have published findings about the company's investigational drug 4-hydroxytamoxifen (4-OHT) gel in the May 2005 issue of the Journal of Clinical Oncology.
The study, "Neoadjuvant Percutaneous 4-Hydroxytamoxifen Decreases Breast Tumoral Cell Proliferation: A Prospective Controlled Randomized Study Comparing Three Doses of 4-Hydroxytamoxifen Gel to Oral Tamoxifen," was led by Dr. Philippe Rouanet of the Centre Val d'Aurelle in Montpellier, France. Results of the published study suggest that 4-OHT gel could represent a well-tolerated treatment for breast cancer chemoprevention, although more study is needed.
Oral tamoxifen has long been shown to have efficacy in preventing the recurrence of breast cancer. Adverse systemic side effects such as blood clots, endometrial cancer and the premature onset of menopausal symptoms, however, remain a problem and often discourage premenopausal women from pursuing a preventive therapy based on oral tamoxifen.
ASCEND's 4-OHT gel is an antiestrogen that is administered directly to the breast skin. In clinical trials to date, plasma levels of 4-OHT after application of the gel have been low, and 4-OHT gel has been shown to avoid systemic side effects. In the published study, researchers analyzed whether the transdermal 4-OHT gel could inhibit the proliferation of malignant breast tumor cells to the same extent as orally administered tamoxifen. At the same time, researchers compared circulating levels of 4-OHT in the plasma after both oral tamoxifen and 4-OHT gel application.
"Dr. Rouanet's study is noteworthy because it provides evidence to support the further investigation of 4-OHT gel in reducing the risk of developing breast cancer or reducing the chance that cancer will recur," said Jay Bua, president and CEO of ASCEND. "This study underscores the potential of 4-OHT gel to deliver therapeutic effects in the breast while avoiding the side effects commonly associated with tamoxifen. We remain committed to evaluating 4-OHT gel for a variety of breast diseases and conditions in premenopausal women, and look forward to the results of our ongoing and future clinical trials."
The study found that the administration of 4-OHT gel resulted in a reduction in tumor tissue proliferation indexes to approximately the same degree as oral tamoxifen. Plasma levels of 4-OHT were dramatically lower in the 4-OHT gel groups than the oral tamoxifen group. The study found that 4-OHT gel appeared to be generally well tolerated.
The official journal of the American Society of Clinical Oncology, the Journal of Clinical Oncology strives to be the single most credible, authoritative resource for disseminating significant clinical oncology research. Original reports remain the publication's focus, but the reports are enhanced with editorials, commentaries, reviews and other works that relate to the care of patients with cancer.
According to the American Cancer Society, breast cancer is the most common cancer among women, other than skin cancer. More than two million women living in the U.S. today have been treated for breast cancer.
ASCEND is using its Enhanced Hydroalcoholic Gel (EHG™) technology to develop a portfolio of transdermal therapies for chronic conditions, including cyclic breast pain and other breast disorders.
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.