SUNNYVALE, Calif., Jan. 3 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
announced today that it has begun enrolling patients in a pilot study designed
to evaluate the safety and tolerability of Natrecor(R) (nesiritide) when
administered in an outpatient setting to patients with chronic advanced
congestive heart failure (CHF) who are at high risk for hospitalization.
Natrecor is currently being used by hundreds of hospitals around the
country to treat patients hospitalized with acute decompensated CHF with
dypsnea (i.e. shortness of breath) at rest or with minimal activity.
"There is an unmet need for more effective outpatient treatment of
advanced chronic CHF that could potentially prevent or reduce
hospitalizations," said Darlene P. Horton, M.D., Scios' Vice President of
Medical Affairs. "Clinicians are interested in using outpatient IV therapy
such as Natrecor for these symptomatic patients, so we will study the safety
and efficacy of this approach, optimal patient selection, dosing and treatment
duration in this setting."
The FUSION (Management of Patients with CHF After Hospitalization with
Follow Up Serial Infusions Of Natrecor) study is a multi-center, randomized,
open-label pilot study that will be conducted at about 40 U.S. sites and will
enroll over 200 patients. Patients will be randomized to receive either their
usual long-term cardiac medications (with or without IV inotropes) or serial
infusions of Natrecor in addition to their usual long-term cardiac medications
(excluding IV inotropes). All treatment groups will have weekly outpatient
visits, and Natrecor patients will receive infusions for at least 4 hours at
each weekly visit. Patients will receive study treatment for 12 weeks. Data
from the FUSION study are expected to be available in late 2002.
"As physicians use more cost-effective clinical settings to manage the
most advanced patients, we believe there is a significant market opportunity
for Natrecor beyond the one million patients hospitalized each year for acute
CHF," said Richard B. Brewer, Scios' president and chief executive officer.
"We plan to further evaluate potential expansions by conducting more clinical
studies like FUSION, implementing the ADHERE national CHF patient registry,
and supporting single-center studies physicians conduct in their areas of
interest."
Natrecor is the first of a new drug class and a recombinant form of B-type
natriuretic peptide (BNP), a hormone secreted by the heart in response to
heart failure.
Scios Inc.
Scios is a biopharmaceutical company developing novel treatments for
cardiovascular and inflammatory disease. The Company's disease-based
technology platform integrates expertise in protein biology with computational
and medicinal chemistry to identify novel targets and rationally design small
molecule compounds for large markets with unmet medical needs.
Forward-Looking Safe Harbor Statement
This news release contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. We generally identify such forward-looking statements
using words like "believe," "intend," "expect," "may," "should," "plan,"
"project," "contemplate," "anticipate" or similar statements. Statements that
are not historical facts are forward-looking statements based on current
assumptions that involve risks and uncertainties. These risks and
uncertainties may include the sales penetration and success of Natrecor, the
success of clinical trials of Natrecor and our pipeline products, including
SCIO-469, as well as other risks detailed from time to time in the reports
filed by Scios with the SEC, including the Company's quarterly reports and
annual report on Form 10-K. Actual results, performance or achievements of
Scios may differ significantly from those described in these forward-looking
statements. Scios disclaims any intention or obligation to update or revise
any financial projections or forward-looking statements, whether as a result
of new information, future events or otherwise.
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
investors, Wendy Carhart of Scios Inc.,
+1-408-616-8325; or media, Jim Weiss of WeissComm,
+1-415-389-5055, for Scios Inc.; or media, Michelle Choi of
Edelman Public Relations, +1-212-704-4580, for Scios Inc.
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