Inhibitex Provides Update on Its Staph Vaccine, FV-100 and INX-189 Development Programs
January 11 2010 - 8:00AM
Business Wire
Inhibitex, Inc. (Nasdaq: INHX) today announced that its
collaborator, Pfizer, Inc., has initiated patient recruitment for
408-patient, randomized, double-blind Phase I clinical trial to
evaluate the safety, tolerability, and immunogenicity of three
ascending dose levels of a 3-antigen Staphylococcus aureus (S.
aureus) vaccine (SA3Ag) in healthy adults. The SA3Ag vaccine
contains an antigen originating from the Company’s MSCRAMM® protein
platform. The Company licensed its MSCRAMM® protein platform to
Wyeth (acquired by Pfizer in 2009) on an exclusive worldwide basis
for the development of active vaccines against staphylococcus in
2001. Pfizer is responsible for all clinical development,
manufacturing and marketing of the vaccine. Inhibitex is eligible
to receive a payment upon the achievement of this and future
regulatory milestones, as well as royalties on future net
sales.
In addition to announcing the initiation of this Phase I vaccine
study, the Company also provided an update on the status of FV-100,
a highly potent oral antiviral compound in Phase II clinical
development for the treatment of herpes zoster (shingles), and
INX-189, a nucleotide polymerase inhibitor in late preclinical
development for the treatment for chronic infections caused by
hepatitis C virus (HCV).
FV-100
The independent Data Safety Monitoring Board (DSMB) responsible
for reviewing data from the Company’s ongoing Phase II clinical
trial of FV-100 met, as scheduled, in early December after the
Company had provided it with complete 30-day follow-up data on the
first quartile of patients enrolled in the trial. Based upon its
review, the DSMB unanimously recommended that the trial should
continue, as originally designed, without modification. The Company
anticipates that an interim analysis of the complete 30-day
follow-up data on the first half (50%) of patients enrolled in the
trial will be completed in the first quarter of 2010. Further, the
Company anticipates completing enrollment in and having top-line
data available from this trial in the second half of 2010.
The Phase II trial is a well-controlled, double-blind study
comparing two arms of FV-100 to an active control (valacyclovir).
The Company plans to enroll and randomize approximately 350
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-related pain, the incidence of post
herpetic neuralgia (PHN), and the time to lesion healing.
INX-189
The Company has completed the requisite Good Laboratory
Practices (GLP) preclinical studies to support the filing of an
investigational new drug application (IND) for INX-189. Based on
the results of these studies, the Company continues to anticipate
filing an IND and, subject to FDA review, initiating a Phase I
clinical trial of INX-189 in the first half of 2010.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical company focused on developing products to treat
serious infectious diseases. The Company’s pipeline includes FV-100
for the treatment of shingles and INX-189, a nucleotide polymerase
inhibitor, 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 timing of an
interim analysis of the 30-day follow-up data from the first half
(50%) of the patients enrolled in the FV-100 Phase II trial; the
anticipated time to complete enrollment in and having top-line data
available from this trial; the anticipated number of patients the
Company plans to enroll in this trial; the anticipated time to file
an IND and initiate a Phase I clinical trial of INX-189; and the
Company’s eligibility to receive future milestone payments and
royalties from Pfizer 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 for lack of safety, manufacturing
issues or other clinical reasons; 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 in a timely basis; the results of ongoing or future
preclinical or clinical studies of INX-189 not supporting its
further development; the Company not obtaining regulatory approval
on a timely basis, or at all, to advance the development of INX-189
into clinical trials; Pfizer halting the clinical development of
its S. aureus vaccine for any reason; obtaining, maintaining and
protecting the intellectual property incorporated into and
supporting the commercial viability of the Company’s product
candidates; maintaining expenses, revenues and other cash
expenditures substantially in line with planned or anticipated
levels; and Wyeth not terminating or revising its license agreement
with the Company. 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, 2008, as filed with the Securities and
Exchange Commission, or SEC, on March 23, 2009 and its Quarterly
Reports on Form 10-Q for the quarter ended September 30, 2009, as
filed with the SEC on November 13, 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)
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