|
-Represents Novel Antibody Approach for Treating Serious Staph Infections-
WASHINGTON, Dec. 16 /PRNewswire-FirstCall/ -- Inhibitex, Inc.
(Nasdaq: INHX) today presented results from a Phase II clinical trial
evaluating Aurexis as a first-line therapy, in combination with standard of
care antibiotics, for serious, life-threatening Staphylococcus aureus
("staph") bloodstream infections at the 45th Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC. This study
was primarily a test of safety and pharmacokinetics, but also represents an
initial step in assessing the potential of Aurexis to improve cure rates over
current standard of care therapy.
Dr. J. John Weems, Professor of Medicine, Department of Medicine, Medical
University of South Carolina, a lead investigator in the study, presented
results from the 60-patient Phase II trial. Patients with both hospital-
associated and community-acquired staph bloodstream infections were included
in the trial. Positive trends were observed in the composite primary endpoint
of mortality, relapse rate and infection-related complications, and a number
of secondary endpoints, including the progression in the severity of sepsis
and days in the intensive care unit. Based on these findings, Inhibitex plans
to initiate additional clinical studies in this indication in 2006.
"More than 60,000 cases of staph bloodstream infection occur annually in
the United States," Dr. Weems reported to the conference attendees.
"Associated mortality and relapse rates remain unacceptably high, and
metastatic complications affect approximately one-third of these patients.
Increasing antibiotic resistance to staph emphasizes the need for alternative
approaches to current therapy."
Serious infections caused by staph represent a growing problem at
hospitals, particularly as bacterial resistance to existing antibiotics
increases. One-half of the patients in the Inhibitex study had infections
caused by staph that were resistant to the most commonly used antibiotics. In
addition to the challenges these infections pose to hospitals, staph
infections that are serious and often resistant to antibiotics are now
appearing in the community at an increasing rate. In fact, in the Inhibitex
study, approximately 30% of the patients had infections that originated in the
community, not in the hospital.
"Unfortunately, it is becoming evident that the development of new
antibiotics is not improving outcomes or keeping pace with the increasing
rates of antibiotic resistance among bacteria," said Dr. William Johnston, CEO
of Inhibitex. "Our strategy at Inhibitex is to develop novel antibody-based
drugs that augment current antibiotics, resulting in significantly improved
therapeutic outcomes."
About Aurexis Phase II Trial
The Phase II trial was a randomized, placebo-controlled, double-blind
study of 60 patients with documented staph bloodstream infections. Patients
were randomized to one of two arms; standard of care antibiotic therapy plus
placebo, or standard of care antibiotic therapy plus Aurexis (single
administration at 20mg/kg). Nearly 60% of the patients already had serious
complications from their staph infection at the time of diagnosis. Four
patients in the group that received antibiotics alone met the primary
composite endpoint, compared with two in the group that also received Aurexis.
The other primary objectives of the study were pharmacokinetics (PK) and
safety. The PK profile indicated that the plasma levels of Aurexis were lower
in infected patients than those observed in healthy subjects in an earlier
Phase I trial. Comparison of adverse events and laboratory values between the
groups demonstrated that Aurexis was generally safe and well tolerated in this
patient population. Among the secondary endpoints, progression in severity of
sepsis was observed in four patients in the group that received antibiotics
alone and none in the group that also received Aurexis. Total hospital days
were similar for both groups of patients; however of those patients admitted
to the ICU, the median duration of stay in the ICU was seven days for patients
who received antibiotics alone compared to three days for patients who also
received Aurexis. The median duration of mechanical ventilation use was eight
days for those receiving Aurexis compared to four days for patients receiving
antibiotics alone. The trial was not powered to show statistically
significant differences in the primary endpoint between the cohorts. The
study was conducted at 12 leading infectious disease hospitals within the
United States.
About Staph Infections
Staph is one of the leading causes of hospital-associated infections.
There were an estimated one million hospital-associated staph infections
worldwide in 2002, of which over 225,000 occurred in the United States.
According to the Centers for Disease Control and Prevention (CDC) and
other sources, the percentage of hospital-associated staph infections in
intensive care units in the United States caused by methicillin-resistant
staph, or MRSA, doubled from 1994 to 2002, increasing from 30% to nearly 60%.
The mortality rate for bloodstream infections associated with MRSA is 30% to
50%. Studies indicate that patients that acquire a MRSA bloodstream
infection, as compared to those that do not, require on average, an additional
12 days in an intensive care unit at an average cost of $27,000.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical company focused on the discovery, development and
commercialization of antibody-based products for the prevention and treatment
of serious, life-threatening infections. The Company currently has five drug
development programs, all of which are based on its proprietary MSCRAMM
protein platform technology. The Companys most advanced product candidates
are Veronate and Aurexis, both of which are in various stages of clinical
development. The Company has retained world-wide rights to both of these
programs. The Companys three preclinical programs include a collaboration
and joint development agreement with Dyax to develop fully human monoclonal
antibodies against MSCRAMM proteins on enterococci and a partnership with
Wyeth to develop staphylococcal vaccines. For additional information about
the Company, please visit http://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 statements
regarding the Companys interpretation of results from its Aurexis Phase II
clinical trial and its intention to initiate additional clinical trials of
Aurexis in 2006 are forward-looking statements. These plans, intentions,
expectations or estimates may not actually be achieved and various important
factors could cause actual results or events to differ materially from the
forward-looking statements that the Company makes, including unanticipated
safety or regulatory issues and other cautionary statements contained
elsewhere herein, in its Annual Report on Form 10-K for the year ended
December 31, 2004 and in risk factors described in or referred to in greater
detail in the "Risk Factors" section of the Companys prospectus, which forms
part of its Registration Statement on Form S-3, which, as amended, was
declared effective by the Securities and Exchange Commission or SEC on
September 21, 2005. 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 Companys 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(R), MSCRAMM(R), Veronate(R) and Aurexis(R) are registered
trademarks of Inhibitex, Inc. (R)
CONTACTS:
Inhibitex, Inc.
Russell H. Plumb
Chief Financial Officer
(678) 746-1136
rplumb@inhibitex.com
Lilian Stern (Investors)
Stern Investor Relations, Inc.
(212) 362-1200
lilian@sternir.com
Kathryn Morris (Media)
KMorrisPR
(845) 635-9828
kathryn@kmorrispr.com
|
|
