Printer Friendly

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: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.
COPYRIGHT 2000 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 
Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Oct 24, 2000
Words:479
Previous Article:THQ Reports Third Quarter Results; 3rd Quarter Net Income Before Pooling Is $0.12 Per Diluted Share, Exceeding Analysts' Expectations.
Next Article:Metrowerks Opens Software Development Lab in India; Noida, India, Site Focuses on Software Development Technology.
Topics:


Related Articles
Plant-based fat may reduce risk of prostate cancer.
The Masculinization of the Fetus During Pregnancy Due to Inhalation of Diesel Exhaust.
The effects of PCB exposure and fish consumption on endogenous hormones. (Articles).
AMGEN'S CANCER DRUG TESTING WELL.
Circulating testosterone and prostate-specific antigen in nipple aspirate fluid and tissue are associated with breast cancer. (Articles).
Current contraceptive research. (Special Report).
Serum levels of 2,2',4,4',5,5'-hexachlorobiphenyl (CB-153) in relation to markers of reproductive function in young males from the general Swedish...
The biocide tributyltin reduces the accumulation of testosterone as fatty acid esters in the mud snail (Ilyanassa obsoleta). (Research).

Terms of use | Privacy policy | Copyright © 2018 Farlex, Inc. | Feedback | For webmasters