Inhibitex Initiates Phase II Clinical Trial of FV-100 for the Treatment of Shingles
May 08 2009 - 7:00AM
Business Wire
Inhibitex, Inc. (Nasdaq: INHX), a biopharmaceutical company
focused on developing products to treat infectious diseases, today
announced that it has initiated a Phase II clinical trial with
FV-100, its oral antiviral compound in clinical development for the
treatment of herpes zoster (shingles).
The Phase II clinical trial is a well-controlled, double-blind
study evaluating FV-100 against an active control (valacyclovir).
Approximately 350 patients, aged 50 years and older, will be
equally randomized to one of three treatment arms: 200 mg FV-100
administered once daily; 400 mg FV-100 administered once daily; and
1,000 mg valacyclovir administered three times per day. In addition
to further evaluating its safety, the objective of the trial is to
evaluate the therapeutic benefit of FV-100 in reducing: the
severity and duration of shingles-related acute pain; the incidence
of post herpetic neuralgia (PHN); the time to lesion healing; and
the use of concomitant pain medications.
�We are pleased to have commenced this well-powered Phase II
trial, in which we will evaluate the potential of FV-100 to treat
shingles as compared to the current standard of care,� stated
Russell H. Plumb, president and chief executive officer of
Inhibitex, Inc. �We plan to ultimately utilize a total of 50-60
U.S. sites in the trial, and we believe this enthusiastic response
from the clinical community reflects its recognition of the
significant unmet medical needs of the increasing number of
shingles patients.�
About Shingles and FV-100
Shingles, also known as herpes zoster, is an infection caused by
the reactivation of varicella zoster virus (VZV), the same virus
that causes chicken pox. Worldwide, it is estimated that there are
greater than 2.5 million cases of shingles each year. Shingles is
generally characterized by the appearance of skin lesions, acute
infection-related pain, and in many cases, post herpetic neuralgia
(PHN), a painful and sometimes debilitating condition that can last
for months or possibly more than a year. While shingles can develop
in individuals of any age, it occurs predominantly in those 40
years of age and older.
Published in vitro studies have demonstrated that FV-100, an
orally-available bicyclic nucleoside analogue, is more potent
against VZV and can inhibit its replication substantially faster
than any other antiviral agent currently approved for the treatment
of shingles. The Company believes these characteristics, coupled
with its pharmacokinetic profile, provide the potential for a
once-a-day dosing regimen of FV-100 to reduce the severity,
duration and incidence of shingles-related symptoms, including
acute pain and PHN.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical company focused on developing products to treat
serious infectious diseases. In addition to FV-100, the Company�s
pipeline includes a series of HCV nucleoside polymerase inhibitors
and HIV integrase inhibitors in preclinical development. Inhibitex
has also licensed the use of its proprietary MSCRAMM� protein
technology to Wyeth for the development of staphylococcal vaccines.
For additional information about the Company, please visit
www.inhibitex.com.
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties. All statements,
other than statements of historical facts included in this press
release, including: those related to the potential for FV-100 to be
dosed once daily and reduce the severity, duration and incidence of
shingles-related symptoms; the number of sites the Company intends
to use in its Phase II trial; and the number of patients the
Company expects to enroll in its Phase II trial are forward-looking
statements. These intentions, expectations, or potentials may not
be achieved in the future and various important factors could cause
actual results or events to differ materially from the
forward-looking statements that the Company makes, including the
risk that: the Company is not able to qualify a sufficient number
of sites or enroll patients at its anticipated rate in the Phase II
trial; the safety results of the Phase II clinical trial of FV-100
do not support its further development; FV-100 does not prove to
have a therapeutic benefit equal to or greater than valacyclovir in
reducing shingles-related symptoms in patients; and other
cautionary statements contained elsewhere herein and in its Annual
Report on Form 10-K for the year ended December 31, 2008, as filed
with the Securities and Exchange Commission, or SEC, on March 23,
2009. Given these uncertainties, you should not place undue
reliance on these forward-looking statements, which apply only as
of the date of this press release.
There may be events in the future that the Company is unable to
predict accurately, or over which it has no control. The Company's
business, financial condition, results of operations and prospects
may change. The Company may not update these forward-looking
statements, even though its situation may change in the future,
unless it has obligations under the Federal securities laws to
update and disclose material developments related to previously
disclosed information. The Company qualifies all of the information
contained in this press release, and particularly its
forward-looking statements, by these cautionary statements.
Inhibitex� and MSCRAMM� are registered trademarks of Inhibitex,
Inc.
Inhibitex, Inc. (MM) (NASDAQ:INHX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Inhibitex, Inc. (MM) (NASDAQ:INHX)
Historical Stock Chart
From Jul 2023 to Jul 2024