Cellegy
Pharmaceuticals, Inc. (Nasdaq: CLGY) announced today that Family Health
International (FHI) plans to stop the Savvy(R) (C31G vaginal gel) Phase 3
trial being conducted in Nigeria to determine whether Savvy is safe and
effective for reducing women's risk of acquiring HIV infection. Funded by
United States Agency for International Development (USAID), the trial was
part of an international effort to evaluate microbicides as a tool to
reduce the risk of HIV infection in people at high risk.
The decision followed a recommendation during a meeting of the study's
external, independent Data Monitoring Committee (DMC). After reviewing the
study data to date, DMC members concluded that the Nigeria trial was
unlikely to provide convincing evidence that Savvy protects against HIV.
Without obvious signals of effectiveness in the interim data, the study
would be unlikely to detect a reduction in the HIV risk if it were to
continue.
After observing a lower than expected rate of HIV seroconversion in the
trial, which was less than half of the expected rate, and after examining
the trial's data, the DMC indicated that continuation of the trial was not
warranted due to a lack of statistical significance in the data. The low
seroconversion rate was possibly due in part to procedures designed to
ensure ethical trial design, including counseling on HIV prevention and
distribution of condoms.
The Savvy trial in Nigeria began screening volunteers in September 2004
and completed planned enrollment with 2,152 women in June 2006. Half of the
women were given Savvy gel, and half were given a placebo gel to be
inserted vaginally with pre-filled applicators before each act of
intercourse. At monthly visits during a year-long follow-up, each
participant was tested for HIV and reported on use of the gel and condoms,
and any side effects or medical problems.
Each participant also received counseling on reducing her risk of HIV
and was given condoms for use during all sex acts. These measures may have
contributed to the lower than expected rate of new HIV infections in the
Nigeria study population. At trial initiation, the anticipated annual rate
of new HIV infections in this population was 3.7 percent. But almost two
years into the study, annual HIV incidence among study participants was
less than 2 percent.
Following this decision, Mr. Richard C. Williams, Cellegy's Chairman
and Interim CEO stated "We are disappointed that the Savvy African trial
ended early. Savvy has proven to be a safe drug in its use by over 4,000
women. The low incidence of infection was due to many factors resulting in
not enough power in the statistical plan. The DMC believes that the current
protocol in the population would not provide convincing evidence of
effectiveness. We agree entirely with the decision to stop the trial due to
the lack of statistical significance present. The U.S. Phase 3 trial of
Savvy for contraception is proceeding as planned. As we have indicated, our
plans to divest or partner certain of our technological assets are
proceeding. We should be able to announce over the course of the next few
weeks some results of these divestment and partnering efforts."
About Cellegy
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.
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: the company's cash position and need and ability to complete
corporate partnerships and additional financings; market acceptance and the
level of future sales of Rectogesic(R) markets outside the United States;
and completion, timing and outcome of clinical trials. For more information
regarding risk factors, refer to the Company's Annual Report on Form 10-K
for the year ended December 31, 2005 and other filings with the Securities
and Exchange Commission.
Cellegy Pharmaceuticals, Inc.
cellegy/
Комментариев нет:
Отправить комментарий