The United States Food and Drug Administration (FDA) was
previously consulted on the protocol
design of all three trials and has
granted a "Fast Track" designation for HIV prevention.3 percent
of pregnant women ages 15 to 44 used an illicit drug in the
past month compared to 10.8
percent
).
SAMHSA, a public health agency within the U.
vaginal vaginosis
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.6 percent) than pregnant women ages 26 to 44 (10.
Information
on fetal alcohol syndrome is available at
http://fascenter.wellness sappho
"These health ramifications are
preventable
.4 percent of non pregnant women in this age group.gov.unsafe trangender
Two other
promising anti-HIV product candidates
with different modes of action are also
in the Biosyn pipeline. 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.
Pregnant women ages 15 to 25 were more likely to have used
an illicit drug
(8.
touching lesbians
The Company is
evaluating the FDA's letter, intends to have further discussions
with the FDA
concerning the letter and is considering alternatives with respect to the
product
. WASHINGTON, Over four percent of pregnant women
ages 15 to 44 used illicit drugs during the
past month, according to new data
released today by the Substance Abuse and Mental Health Services
Administration (SAMHSA).safer unsafe
0 percent) than those ages 26 to 44 (1.samhsa.vaginal safer
A similar formulation of
Rectogesic is
currently being sold in Australia, New Zealand and South Korea.transmitted sappho
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.oas.womyn sexually
For more
information
regarding risk factors, refer to the Company's Annual Report on
Form 10-K for the year ended December
31, 2003 and other filings with the
Securities and Exchange Commission.hotline lesbians
Savvy is a contraceptive
gel for use by women to protect against the
possible contraction of HIV/AIDS. Cellegesic, for the
treatment of anal fissures, was
the subject of an FDA Not Approvable letter in December 2004.
This press release contains forward-looking statements.obstacles amaranth
Cellegy is currently on track
to
have both trials completed in late 2006.
In October 2004, Cellegy acquired Biosyn, Inc, a privately
held
biopharmaceutical company in Huntingdon Valley, Pennsylvania.amaranth affect
SOUTH SAN FRANCISCO, Calif
. Over 1,500 women have enrolled in the trial which first
commenced enrollment in March 2004. The
trials are placebo controlled
double blind studies that compare Savvy with a placebo gel in women
using the
gels for 12 months.std womyn
, Cellegy
Pharmaceuticals, Inc. (Nasdaq: CLGY) announced today that
50% enrollment has
been achieved in the Savvy(R) (C31G vaginal gel) Phase 3 HIV prevention trial
in Ghana based on current projected enrollment. 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.
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 and HIV prevention,
gastrointestinal disorders and certain cancers.Over Four Percent
of Pregnant Women Used Illicit Drugs in Past Month
The data show that pregnant women ages 15 to
25 were
more likely to use illicit drugs than pregnant women ages 26 to 44."
The report,
"Substance Use During Pregnancy: 2002 and 2003 Update," found
that 4.7 percent) than pregnant women
(18 percent).
The report is available on the web at http://www.safer womyn
hotline wurmbrand
In addition to the two
trials taking place in Africa, a Phase 3
contraceptive trial is underway in the United States with
over 200 patients
enrolled to date.
SAMHSA extracted the data from the National Surveys on
Drug Use and
Health, 2002 and 2003.1 percent reported binge alcohol use; and less than
one percent
reported heavy alcohol use (five or more drinks on one occasion
five or more times in a month).sappho trangender
Women in both groups are strongly cautioned on safe sex
practices and encouraged to have their partners
use condoms.responds lesbians
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. These data also show that over four percent of
pregnant women reported binge alcohol use
and 18 percent reported smoking
cigarettes.
"We know that substance use by pregnant women
is a leading cause of
mental, physical and psychological problems in infants and children," SAMHSA
Administrator Charles Curie noted.trangender hiv
ProStrakan will also distribute Tostrex in
the European Union
.
Among pregnant women ages 15 to 44, 9.hotline trangender
SAMHSA is working to get the word out that
women who are pregnant
or plan to become pregnant should not use illicit drugs, alcohol or
cigarettes
.8 percent reported drinking alcohol
during the past month; 4. The data suggest that women ages 15
to 44 increased their
substance use during the year after giving birth, but not to the level of non
pregnant women who were not recent mothers.Sites relating to physical and mental health, disabilities
and diseases which affect women.
bacterial unsafe
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. Binge alcohol use is defined as drinking
five or more drinks on
the same occasion on at least one day in the past month.hotline wellness
The addition of
Biosyn, a leader in the development of novel microbicide gel products for
contraception and the
prevention of HIV in women, expands Cellegy's near term
product pipeline and complements Cellegy
's women's health focus. Cigarette use was higher among non pregnant
women ages 15 to 44 (30.
Substance use rates were lower for recent mothers than for women who were
not recent mothers.
S.sexually obstacles
Cellegy is developing two transdermal testosterone gel products:
Fortigel, a testosterone
replacement therapy for male hypogonadism and
Tostrelle(R) (testosterone gel) for the treatment of
female sexual dysfunction
in postmenopausal women.6 percent).transmitted womyn
Cellegy's Biosyn subsidiary
is conducting two Phase 3 HIV prevention
trials in Africa (Ghana and Nigeria). Launch of Rectogesic
in the United
Kingdom through ProStrakan Group Limited, Cellegy's corporate partner, is
expected
in the first half of 2005. Pregnant
women ages 15 to 25 were more than twice as likely to have smoked
cigarettes
during the past month (27.
sexually affect
Cellegy Announces 50% Enrollment in Phase 3 HIV
Prevention Trial in Ghana
This is a significant
milestone reflecting the rapid accrual of a
large number of trial
participants. Approvals of Rectogesic and Tostrex by the other member
states
of the European Union will be sought through the Mutual Recognition
Procedure.samhsa.affect obstacles
Certain
costs relating to the Phase 3 trials for HIV prevention and
contraception, and other clinical and
preclinical development costs are funded
by approximately $50 million in grant and contract commitments
from the United
States Agency for International Development (USAID), the International
Partnership
for Microbicides (IPM), which receives grants from the Bill and
Melinda Gates Foundation, the National
Institute for Child Health and
Development (NICHD), the National Institute for Allergy and Infectious
Disease
(NIAID), CONRAD and other government and philanthropic organizations. 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.gov or by calling SAMHSA's clearinghouse at 1-800-729-
6686. Department
of Health and
Human Services, is the lead federal agency for improving the quality and
availability
of substance abuse prevention, addiction treatment and mental
health services in the United States
.battered responds
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