Cellegy Issued Patent for Treatment of Female Sexual Dysfunction
SOUTH SAN FRANCISCO, Calif., Aug. 28 /PRNewswire-FirstCall/ -- Cellegy Pharmaceuticals, Inc. (Nasdaq: CLGY) announced today that the United States Patent and Trademark Office (USPTO) has issued patent number 6,610,652 entitled "Microdose Therapy." This patent delineates methods of treating urogenital disorders in females, using a nitric oxide (NO) donor or a phosphodiesterase (PDE) inhibitor. Such urogenital disorders include pain during intercourse (dyspareunia), decreased vaginal lubrication, and decreased vaginal engorgement. Commonly known NO donor compounds include nitroglycerin and sodium nitroprusside; PDE inhibitors include sildenafil (Viagra(TM), Pfizer), vardenafil (Levitra(TM), Bayer) and tadalafil (Cialis(TM), Lilly/ICOS). This patent increases the Company's intellectual property portfolio to 5 issued United States patents and over 20 pending United States and foreign patent applications for the treatment of urogenital disorders and female sexual dysfunctions using NO donors and related compounds. Dyspareunia is characterized by difficult or painful sexual intercourse afflicting approximately 5 million women in the United States. Treating dyspareunia with a nitric oxide donor could potentially provide significant benefits to patients who are poorly served by currently available treatments, such as lubricants. The utility of nitroglycerin ointment in the treatment of vaginal pain was previously demonstrated in a pilot study conducted by Dr. Jennifer Berman at UCLA Medical Center. "Cellegy is pleased to add this issued patent to the Company's expanding intellectual property portfolio for the treatment of urogenital disorders and female sexual dysfunctions using nitric oxide donor compounds," said David A. Karlin, M.D., Cellegy's Vice President, Clinical Development. "We plan to initiate a confirmatory dose ranging clinical study using nitroglycerin for the treatment of dyspareunia before the end of this year." Cellegy Pharmaceuticals is a specialty biopharmaceutical company engaged in the development and marketing of prescription drugs for the treatment of gastroenterology disorders, sexual dysfunction in men and women, and the use of nitric oxide donors for the treatment of certain cancers. The Company is progressing a Phase 3 clinical study for Cellegesic(TM)(nitroglycerin ointment) for the treatment of chronic anal fissure pain. It is also developing Cellegesic for hemorrhoids and dyspareunia. Tostrelle(TM)(testosterone gel) 0.5%, is undergoing a Phase 2 clinical trial for the treatment of sexual dysfunction (decline in libido) in women. Cellegy currently is assessing what additional data will be required by the FDA in order to gain approval of Fortigel(TM)(testosterone gel) 2.0 for the treatment of male hypogonadism. Other nitric oxide donor products in early stage development include treatments for prostate cancer, Raynaud's Disease, Restless Leg Syndrome and erectile dysfunction. This press release contains forward-looking statements. Actual results, particularly with regard to the outcome of clinical trials and discussions with regulatory authorities, may differ materially from those discussed above. There can be no assurance that the Company's issued patents will provide commercial protection against competitive products or technologies. For more information regarding risk factors, refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2002.
SOURCE Cellegy Pharmaceuticals, Inc.
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