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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