Scios VMAC Clinical Trial Data to Be Presented at American Heart Association's
Clinical Trial Results Plenary Session Cleveland Clinic's Jim Young, M.D. to
Present Clinical Trial Data
SUNNYVALE, Calif., Sep 7, 2000 /PRNewswire via COMTEX/ -- Scios Inc. (Nasdaq:
SCIO) today announced that results of the VMAC (Vasodilation in the Management
of Acute Congestive heart failure) clinical trial with the company's lead
product, Natrecor(R) (nesiritide), will be presented at the Clinical Trial
Results plenary session on Wednesday, November 15 during the 73rd Scientific
Session of the American Heart Association meeting in New Orleans.
"I am delighted that the AHA invited us to present the VMAC data at the
Scientific Session meeting in November", said James B. Young, M.D., chairman of
the VMAC Steering Committee and Head, Section of Heart Failure and Cardiac
Transplant Medicine at The Cleveland Clinic Foundation. "It provides an ideal
opportunity to present important new data to a large and clinically relevant
group. It is also a tremendous opportunity to educate this important audience
about the underecognized problem of acute congestive heart failure and a
potential new treatment option."
Enrollment in the VMAC trial was completed at the end of July and patient
follow-up, data collection and analysis are now underway. Typically, the
Clinical Trial Results plenary sessions accommodate four or five presentations
of about 15 minutes each, with a press conference preceding the session. Usually
the session is attended by thousands of cardiologists and scientists interested
in the various topics presented.
"This presentation will create unparalleled visibility for Natrecor and the VMAC
clinical data among our key target audience," said Richard B. Brewer, Scios'
president and chief executive officer. "Because the AHA's embargo policy does
not allow presentation or announcement of late-breaking clinical trial data
prior to the news conference and presentation, we have changed our target date
to announce VMAC data results from late October to November 15, timed with Dr.
Young's presentation at AHA."
Natrecor will be the subject of another poster presentation during the AHA
conference. A copy of this abstract may be obtained from the AHA website
beginning in October (www.scientificsessions.org) or by contacting Scios'
Investor Relations department at 408-616-8325.
Scios expects to file a NDA amendment for Natrecor by the end of 2000. Last
month, positive Phase III acute CHF results from previous Natrecor clinical
trials were published in The New England Journal of Medicine. The safety and
efficacy of this compound will be determined by the U.S. Food and Drug
Administration as part of the market registration process.
About the VMAC Study
The VMAC study is a randomized, double-blind, Phase III trial that evaluated the
hemodynamic and clinical effects of Natrecor, placebo and IV nitroglycerin when
used for the treatment of acutely decompensated CHF in a typical hospital
setting. The trial enrolled 480 patients in 62 centers across the United States.
Patients enrolling in the trial will be randomized into one of four treatment
groups, receiving either Natrecor (fixed dose), Natrecor (adjustable dose),
nitroglycerin or placebo. Natrecor subjects will receive a 2 ug/kg IV bolus,
followed by an infusion of 0.01 ug/kg/min. In the Natrecor adjustable dose arm,
the Natrecor infusion may be adjusted according to a protocol-specific
prescription. The dosing regimen of nitroglycerin will be adjusted to achieve
the desired clinical or hemodynamic effect, according to the usual practice of
the Investigator. The primary analysis will evaluate the effects of Natrecor
plus standard care compared to placebo plus standard care at 3 hours; the
primary endpoints are pulmonary capillary wedge pressure (PCWP) and the
patient's dyspnea (shortness of breath) evaluation. Secondary endpoints are to
compare the hemodynamic and clinical effects of Natrecor with IV nitroglycerin.
Patients eligible to enroll in the study are those who:
-- Require hospitalization and IV therapy for at least 24 hours;
-- Have dyspnea at rest or with minimal activity; and
-- Exhibit elevated cardiac filling pressures.
Scios Inc.
Scios is a biopharmaceutical company engaged in the discovery, development, and
commercialization of novel human therapeutics. Scios has commercial or research
and development relationships with Chiron Corporation, DuPont Pharmaceuticals
Company; Eli Lilly and Company; GenVec, Inc.; Kaken Pharmaceutical Co., Ltd.;
and Novo Nordisk A/S, of Denmark. Additional information on Scios is available
at its web site located at www.sciosinc.com and in the company's various filings
with the Securities and Exchange Commission.
The statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties. These include
the risks concerning the success of the VMAC trial and regulatory approval of
Natrecor, as well as other risks detailed from time to time in the reports filed
by Scios with the SEC, including the company's annual report on form 10-K for
the year ended December 31, 1999 and subsequent reports on form 10-Q.
SOURCE Scios Inc.
CONTACT: investors, Wendy Carhart of Scios Inc., 408-616-8325; or media,
Jim Weiss of WeissComm, 415-203-0328, for Scios Inc.
URL: scientificsessions.org
sciosinc.com |
