Inhibitex Reports Independent Data Safety Monitoring Board Recommends Continuation of Phase II Clinical Trial of FV-100
July 22 2010 - 4:05PM
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 complete 30-day follow-up safety data on the third quartile
(75%) of the patients that the Company plans to enroll in the
trial. Based upon its review, the DSMB recommended that the trial
continue to completion without modification. The Company
anticipates that top-line efficacy 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 to an active control (valacyclovir) in
the treatment of shingles, also referred to as herpes zoster. The
Company plans to enroll and equally randomize approximately 350
patients, aged 50 years and older, 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 clinical-stage
pipeline includes FV-100 for the treatment of shingles and INX-189,
a highly potent nucleotide polymerase inhibitor in Phase I
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 technology 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 have
top-line data available from the Company’s ongoing Phase II
clinical trial of FV-100, 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 a data safety monitoring board (DSMB) suspending or
terminating the clinical development of FV-100 at any time for lack
of safety, manufacturing issues or other clinical reasons, and the
clinical sites participating in the ongoing Phase II trial not
being able to recruit a sufficient number of shingles patients to
complete the trial on a timely basis. 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
and its Quarterly Reports on Form 10-Q for the quarter ended March
31, 2010, as filed with the SEC on May 13, 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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