Columbia Laboratories' Announces Results of Phase I Trial of New Testosterone Progresssive Hydration Vaginal Tablet; Serum Levels of Testosterone Sustained for Several Days.
NEW YORK--(BUSINESS WIRE)--Oct. 24, 2000
Columbia Laboratories (AMEX:COB) today announced the completion of a Phase I trial of its new testosterone Progressive Hydration 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 Tablets (PHBT). 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, 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 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 agent and simultaneously gives all the
benefits of testosterone. In the US alone, approximately 5 million
intact women take Hormone Replacement Therapy.
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, 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.
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|Date:||Oct 24, 2000|
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