Biogen Announces Results of Phase II Trials With ADENTRI(TM) at American Heart Association Meeting
November 10 2003 - 8:13AM
PR Newswire (US)
Biogen Announces Results of Phase II Trials With ADENTRI(TM) at
American Heart Association Meeting CAMBRIDGE, Mass., Nov. 10
/PRNewswire-FirstCall/ -- Biogen today announced positive results
of a Phase II study of oral ADENTRI(TM), an adenosine receptor
antagonist, in patients with stable heart failure. The results were
announced at the annual meeting of the American Heart Association,
which is being held this week in Orlando, Florida. (Logo:
http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO ) "We are very
pleased with the results of our Phase II trial of oral ADENTRI and
plan to meet with the FDA to review these data in preparation for
moving forward with the development of this promising compound,"
said Burt Adelman, M.D., Biogen's Executive Vice President of
Research & Development. The trial was a randomized, double
blind, placebo-controlled study that evaluated the safety,
pharmacology and clinical effects of oral ADENTRI among stable
heart failure patients. Patients were maintained on their usual
medications, including ACE inhibitors and diuretics, and were dosed
with either placebo or one of four doses of ADENTRI, administered
once daily for 10 days. The evaluation of safety, which was the
primary endpoint of the study, did not reveal any significant
safety concerns during the 10 days of dosing or during an
additional 30 days of follow up. In addition, the study showed
increases in sodium excretion above baseline and above placebo
beginning on Day 1, and continuing over the 10-day dosing period.
These effects were not accompanied by reductions in kidney function
or substantial increases in potassium excretion. ADENTRI is a novel
adenosine receptor antagonist that has the potential to maintain
renal function during standard heart failure therapy, while causing
natriuresis (or sodium excretion). About Biogen Biogen is a leader
in biologics research, development and manufacturing. A pioneer in
leading edge research in immunology, neurobiology and oncology,
Biogen brings novel therapies to improve patients' lives around the
world through its global marketing capabilities. For press releases
and additional information about the company, please visit
http://www.biogen.com/. This press release contains forward-looking
statements regarding the expectations for development of ADENTRI.
These statements are based on our current beliefs and expectations.
Actual results could differ materially. Drug development involves a
high degree of risk. Only a small number of research and
development programs result in the commercialization of a product.
Success in animal models or early stage clinical trials does not
ensure that later stage or larger scale clinical trials will be
successful. The results of studies of the product in larger
clinical trials may not be as expected or safety issues or other
problems or delays may arise during clinical trials. For more
detailed information on the risks and uncertainties associated with
these forward looking statements and Biogen's other activities see
the Outlook section in MD&A of Biogen's Annual Report on Form
10-K and Quarterly Reports on Form 10-Q filed with the SEC. Biogen
does not undertake any obligation to publicly update any
forward-looking statements. Media Contact: Kathryn Bloom Senior
Director, Public Affairs Biogen, Inc. Tel: 617-914-6524 Investment
Community Contact: Elizabeth Woo Senior, Director Investor
Relations Biogen, Inc. Tel: 617-679-2812
http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO
http://photoarchive.ap.org/ DATASOURCE: Biogen, Inc. CONTACT: Media
Contact: Kathryn Bloom, Senior Director, Public Affairs,
+1-617-914-6524, or Investment Community Contact: Elizabeth Woo,
Senior, Director Investor Relations, +1-617-679-2812, both of
Biogen, Inc. Web site: http://www.biogen.com/ Company News On-Call:
http://www.prnewswire.com/comp/101550.html
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