ASCEND Therapeutics, Inc. Files Patent Application for the Prevention and Treatment of Breast Cancer Utilizing a Gel Formulation of a Tamoxifen Derivative.Business Editors/Health/Medical Writers HERNDON, Va.--(BUSINESS WIRE)--June 18, 2003 Recent Published Studies Support Oral Tamoxifen's Use to Decrease Risk of Benign Breast Disease benign breast disease See Fibroadenoma, Fibrocystic disease, Mastopathy. , But with Side Effects Side effects Effects of a proposed project on other parts of the firm. ASCEND Therapeutics announced today that it has filed a patent application for the pharmaceutical composition of TamoGel(TM) (4-Hydroxy Tamoxifen tamoxifen (təmŏk`sĭfĕn'), synthetic hormone used in the treatment of breast cancer. Introduced in 1978, tamoxifen is used to prevent recurrences of cancer in women who have already undergone surgery to remove their tumors. (4-OHT) Gel), as well as its use for the prevention and treatment of breast cancer, as well as its pharmaceutical composition. Despite advances in detection and treatment of the disease, breast cancer remains the second leading cause of cancer-related deaths in women, affecting more than 180,000 women in the United States alone each year. The most commonly prescribed medication for breast cancer is tamoxifen. As a treatment for breast cancer, tamoxifen slows or stops the growth of cancer cells that are already present in the body, and helps prevent recurrences and the development of new cancers. Tamoxifen taken orally has significant side-effects however, as it is recognized as both an agonist and antagonist by the body. It provokes a wide range of systemic effects which increase the risk of endometrial cancer, endometrial hyperplasia and polyps Polyps A tumor with a small flap that attaches itself to the wall of various vascular organs such as the nose, uterus and rectum. Polyps bleed easily, and if they are suspected to be cancerous they should be surgically removed. , deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. and pulmonary embolism, changes in liver enzyme levels, and ocular toxicities, including cataracts. In addition, Tamoxifen can cause the onset of menopausal symptoms, such as hot flashes, amenorrhea amenorrhea (āmĕn'ərē`a, əmĕn'–), cessation of menstruation. Primary amenorrhea is a delay in or a failure to start menstruation; secondary amenorrhea is an unexpected stop to the menstrual cycle. , and night sweats, in pre-menopausal women. Because of these side effects, there is an opportunity to develop a derivative of tamoxifen, 4OHT OHT Ocular Hypertension OHT Ozark Highlands Trail OHT Overhead Hoist Transport (manufacturing) OHT Oregon Healthy Teens OHT Orthotopic Heart Transplant OHT One Handed Typing OHT Offshore Heavy Transport OHT Over Head Transmission . 4OHT is formulated in a hydroalcoholic gel, TamoGel(TM), for delivery through the skin. TamoGel(TM) is applied directly to the surface of the breast, where the gel is absorbed directly into the breast tissue. As very little TamoGel(TM) is distributed systemically throughout the body, side-effects of orally administered tamoxifen are significantly decreased. (Pujol, Cancer Chemother Pharmacol, 1995; Mauvais Jarvis, Cancer Research, 1986). "Approximately 10 million women above 35 years of age have a risk for breast cancer significantly elevated enough to make them eligible for chemoprevention che·mo·pre·ven·tion n. The use of chemical agents, drugs, or food supplements to prevent disease. chemoprevention treatment with oral Tamoxifen, according to FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. eligibility criteria. Yet most at-risk women avoid oral tamoxifen because of its side-effects," said Dana C. Hilt, M.D., ASCEND's Chief Medical Officer. "In filing this patent application, we have begun the process that we hope will eventually lead to a non-invasive solution for preventing breast cancer, as well as treating early stages of the disease." TamoGel(TM) is currently in Phase II clinical trials for the treatment of the symptoms of benign breast disease. The company stated that it is also exploring clinical plans to pursue an indication in the area of breast cancer prevention and/or treatment. About Ascend Therapeutics, Inc. Based in Herndon, Virginia, ASCEND Therapeutics, Inc. is an emerging biopharmaceutical company focused on the development of therapeutic products for the treatment of underserved chronic conditions. 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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