Inhibitex Reports Results of Interim Analysis of Phase II Clinical Trial of FV-100
April 12 2010 - 8:30AM
Business Wire
Inhibitex, Inc. (Nasdaq: INHX) today announced that the
independent Data Safety Monitoring Board (DSMB) responsible for
reviewing safety data from the Company’s ongoing Phase II clinical
trial of FV-100 met, as scheduled, after the Company had provided
it with 30-day follow-up data on the first half of the patients
that the Company plans to enroll in the trial. In addition, an
independent statistician conducted a prospectively described
interim analysis on the primary endpoint, which is the reduction in
a composite of the severity and duration of shingles-associated
pain over the first thirty (30) days of follow-up. Based upon the
results of these reviews, the trial will continue, as originally
designed, without modification. The Company, which remains blinded
to the efficacy data, anticipates that top-line data from the
completed trial will be available in the fourth quarter of
2010.
The Phase II trial is a well-controlled, double-blind study
comparing two arms of FV-100, which the Company is developing for
the treatment of shingles, to an active control (valacyclovir). The
Company plans to enroll and randomize approximately 350 shingles
patients, aged 50 years and older, equally 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 objectives of the trial are to evaluate the
potential therapeutic benefit of FV-100 in reducing the severity
and duration of shingles-associated pain, the incidence of post
herpetic neuralgia (PHN), and the time to lesion healing.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical company focused on developing products to prevent
and treat serious infectious diseases. The Company’s pipeline
includes FV-100 and INX-189, a nucleotide polymerase inhibitor in
development for the treatment of chronic hepatitis C infections.
The Company has additional HCV nucleotide polymerase inhibitors in
preclinical development, and has also licensed the use of its
proprietary MSCRAMM® protein platform to Pfizer for the development
of staphylococcal vaccines.
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 to complete and
have top-line data available from its ongoing Phase II trial, and
the anticipated number of patients the Company plans to enroll in
this trial, are forward looking statements. These intentions,
expectations, or results may not be achieved in the future and
various important factors and risks could cause actual results or
events to differ materially from the forward-looking statements
that the Company makes, including the risk of: either the Company,
the FDA, an investigational review board, or the DSMB suspending or
terminating the clinical development of FV-100 for safety concerns,
manufacturing issues or lack of efficacy; FV-100 not demonstrating
sufficient efficacy in reducing the incidence and severity of
shingles-related symptoms, including acute pain and PHN, to be
clinically relevant or commercially viable; the clinical sites
participating in the FV-100 Phase II trial not being able to
recruit a sufficient number of shingles patients to complete the
trial on a timely basis; and obtaining, maintaining and protecting
the intellectual property incorporated into and supporting the
commercial viability of the Company’s product candidates. Further
information regarding these factors and risks can be found in the
Company’s 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. 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)
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