To: Magic212 who wrote (232 ) 3/29/2000 9:47:00 AM From: Magic212 Read Replies (1) | Respond to of 322
Cellegy Pharmaceuticals Initiates Phase III Clinical Trial Using Transdermal Testosterone Gelbiz.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.