FREMONT, Calif., April 18 /PRNewswire-FirstCall/ -- Protein Design Labs,
Inc. (PDL) (Nasdaq: PDLI) today reported positive results from a Phase II
clinical study, known as the SIRIUS II trial, of the natriuretic peptide
ularitide in patients with decompensated congestive heart failure (DHF).
The SIRIUS II trial was a randomized, double-blind, placebo-controlled
clinical trial conducted at 19 centers in Europe. Primary endpoints in the
study were change in pulmonary capillary wedge pressure (PCWP) and change in
dyspnea (shortness of breath) score, both at six hours. A total of 221
patients were randomized equally to receive ularitide 7.5, 15, or 30 ng/kg/min
given intravenously as a 24-hour infusion, or placebo. In the assessment of
the primary endpoints, ularitide significantly reduced PCWP (p<0.05) and
improved dyspnea score (p<0.05) in all three dose groups compared to placebo.
The main adverse events through day three were dose-dependent decreases in
blood pressure compared to placebo. Serum creatinine levels were unchanged
during and after ularitide treatment when compared to placebo. The incidence
of serious adverse events was similar for all three treatment groups and the
placebo group.
"Based on these encouraging data, we intend to further study ularitide as
a potential treatment for patients with decompensated congestive heart
failure," said Steven Benner, M.D., Senior Vice President and Chief Medical
Officer, PDL. "We have submitted an abstract summarizing these data for
possible presentation at the Scientific Meeting of the Heart Failure Society
of America to be held September 18-21 at Boca Raton, Florida. We may
additionally submit an abstract to the European Society of Cardiology Congress
to be held in Stockholm, Sweden, September 3-7." Following these potential
presentations, PDL expects to discuss its development strategy and future
study timelines during an R&D Update to be scheduled for late September or
early October 2005 in New York.
The SIRIUS II clinical trial was conducted by CardioPep Pharma GmbH. PDL
has acquired from CardioPep, through a license agreement between CardioPep and
ESP Pharma, Inc., PDL's wholly-owned subsidiary, exclusive rights to conduct
all subsequent development and exclusive marketing rights for ularitide for
all indications in the United States, Canada, the European Union and
Switzerland. To date, the clinical development of ularitide has taken place
in Europe. A U.S. IND has not yet been filed by CardioPep.
About Ularitide
Ularitide is processed from the same gene that produces atrial natriuretic
peptide in the heart. The peptide was first isolated by scientists affiliated
with the group of Wolf-Georg Forssmann at Heidelberg University, and has been
developed by a German company, CardioPep Pharma GmbH.
In a previous Phase IIa study in patients with DHF, referred to as the
SIRIUS I trial, ularitide was shown to enhance natriuresis and diuresis, and
to decrease central venous pressure. The SIRIUS I trial was a double-blind,
placebo-controlled ascending-dose study. This trial enrolled 24 patients who
received a 24-hour infusion of placebo, or in ascending dose cohorts, 7.5, 15
or 30 ng/kg/min of ularitide. The study was primarily intended to assess
safety, but evidence of hemodynamic activity was observed at the two higher
dose levels when assessed at six hours. There was no apparent difference in
adverse events across the four treatment groups. Results of the SIRIUS I
study are now in press in the American Heart Journal.
About Decompensated Congestive Heart Failure (DHF)
DHF is a serious medical condition in which the heart is unable to
maintain adequate circulation of blood in the tissues of the body or to pump
out the venous blood returned to it by the venous circulation. In the United
States alone, there are approximately one million hospitalizations per year
for decompensated congestive heart failure.
About Protein Design Labs
Protein Design Labs is a fully-integrated biopharmaceutical company
focused on the development and commercialization of novel therapies for
treatment of inflammation and autoimmune diseases, acute cardiac conditions
and cancer. As a leader in the development of humanized antibodies, PDL has
licensed its patents to numerous pharmaceutical and biotechnology companies,
some of which are now paying royalties on net sales of licensed products. PDL
markets several pharmaceutical products in the United States through its
wholly-owned subsidiary, ESP Pharma, Inc. Further information on PDL is
available at http://www.pdl.com or by contacting James R. Goff, Senior Director, PDL
Corporate Communications, 510-574-1421 or jgoff@pdl.com.
The foregoing contains forward-looking statements involving risks and
uncertainties and PDL's actual results may differ materially from those in the
forward-looking statements. Factors that may cause such differences are
discussed in the Company's Annual Report on Form 10-K for the year ended
December 31, 2004, and other filings made with the Securities and Exchange
Commission. In particular, results obtained in the Phase II study may not be
predictive of results to be obtained in the additional evaluations that would
be necessary to demonstrate ularitide to be safe and effective in the
treatment of decompensated congestive heart failure, nor can there be
assurance that PDL will initiate subsequent clinical trials of ularitide.
NOTE: Protein Design Labs and the PDL logo are registered U.S. trademarks
of Protein Design Labs, Inc.
SOURCE Protein Design Labs, Inc.
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Related links:
http://www.pdl.com
CONTACT:
James R. Goff, Senior Director, Corporate
Communications of Protein Design Labs, Inc., +1-510-574-1421, or
jgoff@pdl.com
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