Cellegy Pharmaceuticals Initiates Phase III Clinical
Trial Using Transdermal Testosterone Gel
biz.yahoo.com
SOUTH SAN FRANCISCO, Calif., March 29 /PRNewswire/ -- Cellegy Pharmaceuticals, Inc. (Nasdaq: CLGY - news) today
announced that it has initiated a pivotal Phase III clinical trial using its transdermal testosterone gel, Tostrex(TM), for the
treatment of male hypogonadism, a disorder frequently characterized by diminished libido, reduced muscle size and
strength. This study will enroll hypogonadal patients at 8 to 10 prominent medical centers in the United States for a
treatment period of six months.
Up to 5 million men in the United States, particularly those in the over age 40 category, have low testosterone levels. The
potential domestic market for testosterone replacement therapy is estimated to be in excess of $2 billion per year. Cellegy's
elegantly formulated, proprietary topical gel has the potential to provide this large patient population with an effective
product. If successfully developed, Tostrex may be more convenient than injections, less irritating than current patch
products and applied to a smaller area than alternative gel products.
``Patients and physicians have expressed significant interest in an effective, easy to use testosterone gel product, with a
better side effect profile than currently marketed products,' said Mr. K. Michael Forrest, Cellegy's President and CEO.
``Given the relatively small size of this study and the high level of interest, we expect that patient recruitment will be
straightforward.'
Tostrex is the second Cellegy product undergoing Phase III clinical testing. Earlier this month the company commenced a
pivotal Phase III clinical trial using Anogesic© (nitroglycerin ointment) for the treatment of pain associated with anal
fissures. Cellegy is also conducting two Phase II clinical trials using Anogesic to treat various complications of
hemorrhoids, a related condition that afflicts over 9 million people in the United States alone. In addition to Tostrex,
Cellegy has a second testosterone gel product, Tostrelle(TM), which is currently undergoing a Phase I/II dose ranging
study for the treatment of decreased sexual energy (libido) in postmenopausal women. Cellegy has also developed a line of
high performance cosmeceutical products which have been shown in clinical tests to produce significant improvements in
the appearance of photodamaged and wrinkled skin.
This press release contains certain forward-looking statements. Many factors could cause actual results to differ
materially from those anticipated by the statements made in this press release. Among, but not limited to these, are
unfavorable clinical results in any of the Company's trials or other difficulties relating to the development and
commercialization of our products. For more information regarding financial results, including risk factors, refer to the
Company's Annual Report on Form 10-K for the year ended December 31, 1999.
SOURCE: Cellegy Pharmaceuticals, Inc. |
