Chiron & Searle initiate plans for Phase III trials on Sepsis.
quote.bloomberg.com
EMERYVILLE, Calif., Dec. 2 /PRNewswire/ -- Chiron Corporation
(Nasdaq: CHIR) announced today that the company and its partner G.D. Searle
& Co., the pharmaceutical sector of Monsanto Company (NYSE: MTC), have
initiated plans for a pivotal Phase III trial for their tifacogin compound
(tissue factor pathway inhibitor, or TFPI). The two companies based their
decision on data from the recently completed Phase II safety and dose-ranging
trial of tifacogin in patients with severe sepsis and detailed discussions
with the Food and Drug Administration (FDA). Tifacogin, a recombinant form of
TFPI, is believed to block a critical event in sepsis, namely tissue-factor
mediated clotting in small blood vessels, which potentially leads to organ
failure and death.
"The primary objective of our Phase II study was to assess the safety of
tifacogin in a heterogeneous patient population with severe sepsis. We are
encouraged by the results of the Phase II study," said Lewis (Rusty) T.
Williams, M.D., Ph.D., Chiron's chief scientific officer and president of R&D,
"and our goal is to initiate a pivotal trial next year to fully assess the
therapeutic potential of this compound."
Conducted in the U.S. and Europe, the Phase II trial was a multi-center,
single-blind, placebo-controlled, dose-escalation study. The 210 patients
enrolled in the study received placebo or one of two different tifacogin doses
by continuous intravenous infusion for up to four days, and were monitored
through day 28 following treatment. The primary objective of the study was to
identify a tifacogin dose regimen that was safe in severe sepsis patients. The
secondary objectives were related to resolution of organ dysfunction and to
reduction of 28-day all-cause mortality.
TFPI, which is normally produced by the body, inhibits one of the key
steps in blood coagulation that ultimately lead to clot formation. By blocking
the production of thrombin, it minimizes the formation of fibrin clots. It is
these clots that are believed to play a significant role in clogging small
blood vessels, an event that ultimately leads to multiple-organ failure. TFPI
also decreases the production of molecules implicated in the body's
exaggerated inflammatory response in severe sepsis. This dual mechanism of
action may prove beneficial in reducing multiple organ failure, a major cause
of death in severe sepsis. There is currently no approved therapeutic for this
life-threatening condition and approximately 30 to 50 percent of those who
develop severe sepsis die.
About Chiron
Chiron Corporation, headquartered in Emeryville, California, is a leading
biotechnology company that participates in three global healthcare markets:
biopharmaceuticals, vaccines and blood testing. The company is applying a
broad and integrated scientific approach to the development of innovative
products for preventing and treating cancer, infectious diseases and
cardiovascular disease. For more information about Chiron, visit the company's
Web site at www.chiron.com.
About Searle/Monsanto
Searle, the pharmaceutical sector of Monsanto Company, develops, produces
and markets prescription pharmaceuticals worldwide. The company focuses its
expertise on five therapeutic areas: arthritis, cardiovascular disease,
cancer, sleep, and women's health. For more information on Searle, access
www.searlehealthnet.com.
As a life sciences company, Monsanto is committed to finding solutions to
the growing global needs for food and health by sharing common forms of
science and technology among agriculture, nutrition and health. In
1998, Monsanto reported sales of $8.6 billion and invested approximately
$1 billion in research and development.
This news release may contain forward-looking statements regarding
tifacogin and its effect on patients with sepsis. Actual results could differ
materially from those described in this news release as a result of a number
of factors, including, but not limited to the following: There can be no
assurance that final results of human clinical trials will be supportive of
regulatory approvals required to market products, or that final regulatory
approval will be received in a timely manner, if at all, or that any product
in the Chiron product pipeline will be successfully developed or manufactured,
or that patient and physician acceptance of these products will be achieved,
nor can there be any assurance as to the impact of competitive products or
other market conditions. These and other factors investors should consider are
more thoroughly discussed in the company's filings with the Securities and
Exchange Commission, including the Form 10-K and Form 10-Q. Chiron does not
undertake any obligation to revise or update the statements in this press
release to reflect events or circumstances after the date of this release.
SOURCE Chiron Corporation
-0- 12/02/1999
/CONTACT: Julie Wood, Senior Director, Corporate Communications and
Investor Relations, 510-923-6686, or Gabrielle Friedly, Manager, Corporate
Communications, 510-923-6905, both of Chiron Corporation/
/Web site: searlehealthnet.com
/Web site: chiron.com
(CHIR MTC) |
