Cellegy Pharmaceuticals Announces Update To Savvy Phase 3 HIV Prevention Trials
HUNTINGDON VALLEY, Pa., Oct. 27 /PRNewswire-FirstCall/ -- Cellegy Pharmaceuticals, Inc. announced today that 100% enrollment has been achieved in the Savvy(R) (C31G vaginal gel) Phase 3 HIV prevention trial in Ghana based on current projected enrollment. A total of 2,142 subjects are now enrolled in Ghana. Enrollment in the second HIV prevention trial in Nigeria has reached 85% of projected enrollment, with over 1,800 subjects now enrolled.
Additionally, the first interim analysis has taken place, and the Data Monitoring Committee (DMC) found no reason to interrupt or stop the trial, based on a review of safety and number of sero-conversions to date. However, sero-conversions in the trial are running lower than projected, and as a result additional statistical analyses will be conducted and presented to the DMC over the next several weeks, to determine if modifications to the protocol are required.
Cellegy's Biosyn subsidiary is conducting two Phase 3 HIV prevention trials in Africa (Ghana and Nigeria). The trials are placebo controlled double blind studies that compare Savvy with a placebo gel in women using the gels for 12 months. Women in both groups are strongly cautioned on safe sex practices and encouraged to have their partners use condoms. The primary endpoint of the studies is a 50% reduction in the rate of transmission of HIV in the Savvy group compared with the control.
In addition to the two trials taking place in Africa, a Phase 3 contraceptive trial is underway in the United States with over 500 subjects enrolled to date -- approximately one-third of the projected enrollment. A second Phase 3 contraception trial is planned in order to meet the requirements of the United States Food and Drug Administration (FDA) for consideration by the agency of approval of Savvy as a contraceptive.
Savvy is a contraceptive gel for use by women to protect against the possible contraction of HIV/AIDS. The gel, part of a class of drugs known as microbicides, is acknowledged to be the most advanced product in the race to demonstrate efficacy of microbicides in the prevention of HIV. In addition to HIV, Savvy has also shown activity that suggests protection against other sexually transmitted diseases (STDs), including those caused by herpes simplex virus (HSV), chlamydia, trichomonas, gonorrhea and syphilis. The FDA has granted a "Fast Track" designation for HIV prevention.
Two other promising anti-HIV product candidates with different modes of action are also in the Biosyn pipeline. UC-781 has recently entered expanded Phase 1 trials at Emory University in Atlanta, designed to assess the safety of UC-781 in HIV negative and HIV positive subjects. Additional trials will commence in 2006 in Thailand and Botswana with similar endpoints. Also, Cyanovirin-N (CV-N) a novel protein fusion inhibitor is currently on track for an IND filing in late 2006.
Cellegy Pharmaceuticals is a specialty biopharmaceutical company that develops and commercializes prescription drugs for the treatment of women's health care conditions, including sexual dysfunction, HIV prevention and gastrointestinal disorders.
Cellegesic(TM) (nitroglycerin ointment), branded Rectogesic(R) outside the United States, is approved in the United Kingdom for the treatment of pain associated with chronic anal fissures. Rectogesic is marketed in the United Kingdom by ProStrakan Group Limited, Cellegy's corporate partner. In December 2004, the Medical Products Agency (MPA) in Sweden approved Fortigel(TM) (testosterone gel), branded Tostrex(R) outside the United States, for the treatment of male hypogonadism. Tostrex was recently launched in Sweden by ProStrakan. Approvals of Rectogesic and Tostrex by the other member states of the European Union will be sought through the Mutual Recognition Procedure. Cellegesic, for the treatment of anal fissures, was the subject of an FDA Not Approvable letter in December 2004, was resubmitted to the FDA in April 2005 and is currently under review at the FDA.
Forward Looking Statements
This press release contains forward-looking statements. Investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such risks and uncertainties relate to, among other factors: completion, timing and outcome of clinical trials, including primarily the Savvy prevention and contraceptive Phase 3 studies; and the need and ability to complete corporate partnerships and additional financings. For more information regarding risk factors, refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2004 and other filings with the Securities and Exchange Commission.Cellegy Pharmaceuticals, Inc.
CONTACT: Richard Williams, Chairman and Interim CEO, +1-650-616-2200, orRobert J. Caso Vice President, Finance & CFO, +1-215-914-0900, ext. 603,both of Cellegy Pharmaceuticals, Inc.; or Anne-Marie Corner, Senior VicePresident, Women's Preventive Health, +1-215-914-0900, ext. 601
Web site: http://www.cellegy.com/