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IntraBiotics Stopped Iseganan Trial in Ventilator-Associated Pneumonia for Safety Reasons
PALO ALTO, Calif., Jun 23, 2004 /PRNewswire-FirstCall via COMTEX/ --
IntraBiotics Pharmaceuticals, Inc. (Nasdaq: IBPI) today announced that an
independent data monitoring committee recommended to the company that it
discontinue its pivotal trial of iseganan for the prevention of
ventilator-associated pneumonia based on an interim analysis of the data. A
higher rate of both ventilator-associated pneumonia and mortality was observed
by the data monitoring committee in the active treatment group compared to the
placebo group. As a result, IntraBiotics has stopped the study.
"This interim analysis outcome was unexpected, since we had concluded that
iseganan was safe and well tolerated based on previous studies in over 800
patients," stated Henry Fuchs, M.D., President and CEO of IntraBiotics.
IntraBiotics has not yet been provided with detailed data from the analysis
performed by the data monitoring committee. IntraBiotics intends to work with
the data monitoring committee to better understand the data and to determine
appropriate further steps.
A conference call and web cast are scheduled for Wednesday, June 23, 2004, at
9:00 a.m. EDT / 6:00 a.m. PDT. The conference call can be accessed by dialing
719-457-2638.
Those who wish to listen to the call may participate via live web cast at
http://shareholder.com/intrabiotics/medialist.cfm . A replay of the
teleconference will be available through June 30, 2004 and can be accessed by
dialing 719-457-0820. The Confirmation code for the replay is 230711.
Certain statements in this press release contain forward-looking information and
are subject to risks and uncertainties, such as statements regarding product
development, clinical developments and the sufficiency of our cash resources. As
such, they are subject to the occurrence of many events outside of IntraBiotics'
control and are subject to various risk factors that could cause IntraBiotics'
results to differ materially from those expressed in any forward-looking
statement. A discussion of such risks and uncertainties, which could case actual
results to differ from those contained in the forward-looking statements, are
more fully described in documents on file with the Securities and Exchange
Commission including, but not limited to our Annual Report on Form 10-K for the
fiscal year ended December 31, 2003, as filed with the SEC on March 19, 2004 and
our Registration Statement on Form S-1 as filed with the SEC on April 14, 2004,
as amended.
SOURCE IntraBiotics Pharmaceuticals, Inc.
CONTACT: investors, Joyce Bremer of IntraBiotics Pharmaceuticals, Inc.,
+1-650-526-6818; or media, Carolyn Bumgardner of WeissCom Partners, Inc.,
+1-415-362-5018, or cell, +1-415-225-5050, for IntraBiotics Pharmaceuticals
URL: http://www.intrabiotics.com
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Copyright (C) 2004 PR Newswire. All rights reserved.
KEYWORD: California
INDUSTRY KEYWORD: HEA
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SUBJECT CODE: SVY
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