Columbia Laboratories' Announces Results of Phase I Trial of New Testosterone Progresssive Hydration Vaginal Tablet; Serum Levels of Testosterone Sustained for Several Days.Business Editors/Health & Medical Writers NEW YORK--(BUSINESS WIRE)--Oct. 24, 2000 Columbia Laboratories (AMEX AMEX See: American Stock Exchange :COB) today announced the completion of a Phase I trial of its new testosterone Progressive Hydration hydration /hy·dra·tion/ (hi-dra´shun) the absorption of or combination with water. hy·dra·tion n. 1. The addition of water to a chemical molecule without hydrolysis. 2. Vaginal Tablet (PHVT) for women. The study demonstrated that with the use of this new technology, testosterone could be delivered vaginally over a period of days. This new technology is also being used in Columbia Laboratories' Progressive Hydration Buccal buc·cal adj. 1. Of, relating to, adjacent to, or in the direction of the cheek. 2. Of or relating to the mouth cavity. buccal Tablets (PHBT PHBT pseudomorphic heterojunction bipolar transistor ). We expect to announce Phase II clinical results on the male testosterone PHBT shortly. Additionally, by the end of the year, we hope to be able to demonstrate the effectiveness of the Progressive Hydration technology in delivering peptides. In the Phase II Trial of PHVT, Columbia will seek to refine the dose to achieve physiologic levels in serum/brain/bone while at the same time producing supra-physiologic levels in the endometrium endometrium /en·do·me·tri·um/ (-me´tre-um) pl. endome´tria the mucous membrane lining the uterus. en·do·me·tri·um n. pl. , the lining of the uterus. Because of Columbia's patented "First Uterine Pass Effect," we hope to establish that this small tablet, 6 mm in diameter, used twice a week will enhance libido, provide an increased sense of well being, decrease the risk of osteoporosis and also produce an atrophic endometrium. If successful, potential clinical uses of PHVT will be: 1) To shrink the portion of fibroids Fibroids Benign tumors of muscle and connective tissue that develop within or are attached to the uterine wall. Mentioned in: Menstrual Disorders that sticks into the endometrium and causes severe bleeding which often becomes an indication for hysterectomy. 15% of women in the general population and as many as 50% of African American women above the age of 35 have fibroids. There is no approved medical therapy for fibroids. 2) To create a no-bleed menopause regimen that eliminates the need for a progestational progestational /pro·ges·ta·tion·al/ (pro?jes-ta´shun-al) 1. referring to that phase of the menstrual cycle just before menstruation, when the corpus luteum is active and the endometrium secreting. 2. agent and simultaneously gives all the benefits of testosterone. In the US alone, approximately 5 million intact women take Hormone Replacement Therapy Hormone Replacement Therapy Definition Hormone replacement therapy (HRT) is the use of synthetic or natural female hormones to make up for the decline or lack of natural hormones produced in a woman's body. . Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to research and development of women's health care products, including those intended to treat infertility, dysmenorrhea dysmenorrhea Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur. , endometriosis, hormonal deficiencies. Columbia is also developing hormonal products for men and a buccal delivery system for peptides. Columbia's products primarily utilize the company's patented bioadhesive delivery technology. This press release contains statements which constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent, belief or current expectations of the company and its management team. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Such risks and uncertainties include, among other things, competitive economic, and regulatory factors in the pharmaceutical and health care industry, general economic conditions and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion