Inhibitex Completes Enrollment in Phase II Clinical Trial of FV-100 in Shingles Patients
October 15 2010 - 8:00AM
Business Wire
Inhibitex, Inc. (Nasdaq: INHX), announced today that it has
completed enrollment in a Phase II clinical trial of FV-100 in
shingles (herpes zoster) patients. The objectives of the trial are
to further evaluate the safety of FV-100 and its potential
therapeutic benefit in reducing the severity and duration of
shingles-associated pain, the incidence of post herpetic neuralgia
(PHN), and the time to heal shingles-related lesions.
The Phase II trial is a well-controlled, double-blind study of
350 shingles patients, aged 50 years and older with
shingles-associated pain, who were randomized equally to one of
three treatment arms: 200 mg or 400 mg FV-100 administered orally
once daily, or 1,000 mg valacyclovir administered orally three
times per day. The Company anticipates top-line data from the trial
will be available later this quarter.
About Shingles and FV-100
Shingles is an infection caused by the reactivation of varicella
zoster virus (VZV), the same virus that causes chicken pox.
Worldwide, it is estimated that more than 2.5 million new cases of
shingles occur each year, and that one in four adults will suffer
from shingles during their lifetime. While shingles can develop in
adolescents or adults of any age, it occurs predominantly in
individuals 40 years of age and older. Shingles is generally
characterized by skin lesions or rash, acute infection-related
pain, and in many cases, PHN, which is a painful and often
debilitating chronic complication that impacts approximately one
out of every five shingles patients. PHN can last for months or
possibly years, and has been shown to have a measurable and
significant impact on patients’ quality of life and functional
status.
Published in vitro studies have demonstrated that FV-100, an
orally available bicyclic nucleoside analogue, is significantly
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, plus a favorable pharmacokinetic profile, support
the potential of FV-100 as a highly potent, once-daily oral therapy
to reduce the incidence, severity and duration of shingles-related
symptoms, including acute pain and PHN.
About Inhibitex
Inhibitex, Inc. is a biopharmaceutical company focused on
developing products to prevent and treat serious infectious
diseases. In addition to FV-100, the Company’s clinical stage
pipeline includes INX-189, a nucleotide polymerase inhibitor in
Phase I development for the treatment of chronic infections caused
by hepatitis C virus (HCV). The Company also has additional HCV
nucleotide polymerase inhibitors in various stages of preclinical
development, and has licensed the use of its proprietary MSCRAMM®
protein platform to Pfizer for the development of active
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 historical facts included in this press release,
including statements regarding: the anticipated time when top-line
data will be available from the Company’s ongoing Phase II clinical
trial of FV-100 and the potential for FV-100 to be a highly potent,
once-daily oral therapy and reduce the incidence and severity of
shingles-related symptoms, including acute pain and PHN, are
forward looking statements. These intentions, expectations, or
results 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’s contract research
organizations cannot provide top line data from the Phase II trial
to the Company in a timely manner; FV-100 not demonstrating
sufficient benefit in reducing the incidence and severity of
shingles-related symptoms, including acute pain and PHN, to be
clinically relevant or commercially viable; and other cautionary
statements contained elsewhere herein and in its Annual Report on
Form 10-K for the year ended December 31, 2009, as filed with the
Securities and Exchange Commission, or SEC, on March 26, 2010, and
its Quarterly Report on Form 10-Q for the quarter ended June 30,
2010, as filed with the SEC on August 12, 2010. 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