Nuvelo Announces Positive Results from Phase 1 Clinical Trial of NU206 in Healthy Volunteers
10 Décembre 2008 - 2:30PM
PR Newswire (US)
SAN CARLOS, Calif., Dec. 10 /PRNewswire-FirstCall/ -- Nuvelo, Inc.
(NASDAQ:NUVO) today announced positive results from the Phase 1
trial of recombinant, secreted protein, NU206, the company's lead
compound from its Wnt Therapeutics Program. This single-center,
double-blind, placebo-controlled, single-ascending dose (SAD) trial
tested the safety, tolerance and pharmacokinetics of a single
intravenous (IV) administration of NU206, in 32 healthy male
volunteers. Participants were enrolled in four cohorts of varying
doses, with a maximum dose of 0.20 mg/kg/day. NU206 had a favorable
safety profile, no serious adverse events were observed, and
pharmacokinetics were predictable. "Based on preclinical studies,
we believe that NU206 promotes cell growth and repair, and, based
also on results from this Phase 1 trial, believe it has the
potential to offer a novel approach for the treatment of serious
medical conditions such as gastrointestinal (GI) injury,
inflammatory bowel disease, and bone disease," said Dr. Ted W.
Love, chairman and chief executive officer of Nuvelo. "Because
Nuvelo is in the process of merging with ARCA biopharma to create a
cardiovascular-focused company, we are currently evaluating
partnership and out-licensing opportunities for NU206 to continue
development of the compound." About NU206 NU206 (R-spondin1) is a
recombinant, secreted protein that acts as a key regulator of the
Wnt pathway, the critical pathway that stimulates cell growth and
differentiation during homeostasis and pathogenesis in specific
tissues including the GI epithelium and bone. Preclinical studies
suggest it can promote growth and repair in animal models of
radiation or cancer chemotherapy induced GI injury, inflammatory
bowel disease, and bone disease. About Nuvelo and Kyowa Hakko
Kirin's Joint Collaborative Effort Scientists from Nuvelo and Kyowa
Hakko Kirin worked together to identify and characterize NU206 as
part of a collaboration focused on the discovery of novel, secreted
proteins. Nuvelo signed a collaboration agreement with Kyowa Hakko
Kirin in April 2005 to develop NU206. Under the agreement, Nuvelo
leads worldwide development, manufacturing and commercialization
and all operating expenses and profits related to the development
and commercialization of NU206 are shared 60% (Nuvelo)/40% (Kyowa
Hakko Kirin). About Nuvelo Nuvelo, Inc. is dedicated to improving
the lives of patients through the discovery, development and
commercialization of novel drugs for acute cardiovascular disease,
cancer and other debilitating medical conditions. Nuvelo's
development pipeline includes NU172, a direct thrombin inhibitor
which has completed Phase 1 development for use as a potential
short-acting anticoagulant during medical or surgical procedures;
and NU206, a Wnt pathway modulator in Phase 1 development for the
potential treatment of chemotherapy/radiation therapy-induced
mucositis and inflammatory bowel disease. In addition, Nuvelo is
pursuing research programs in leukemia and lymphoma therapeutic
antibodies and Wnt signaling pathway therapeutics to further expand
its pipeline and create additional partnering and licensing
opportunities. Information about Nuvelo is available at its website
at http://www.nuvelo.com/ or by phoning 650-517-8000.
Forward-looking statements This press release contains
"forward-looking statements" which include, without limitation,
statements regarding the completion of the proposed merger
transaction between Nuvelo, ARCA biopharma, Inc., or ARCA, and Dawn
Acquisition Sub, Inc., the timing, progress and anticipated
completion of Nuvelo's clinical stage programs, the potential
benefits that patients may experience from the use of our clinical
stage compounds, and potential partnership and out-licensing
opportunities, which statements are hereby identified as
"forward-looking statements" for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995.
Such statements are based on our management's current expectations
and involve risks and uncertainties. Actual results and performance
could differ materially from those projected in the forward-looking
statements as a result of many factors, including, without
limitation, failure of Nuvelo or ARCA's stockholders to approve the
merger, the ability to complete the transaction contemplated by
this communication in a timely fashion, uncertainties relating to
drug discovery and the regulatory approval process; clinical
development processes; enrollment rates for patients in the
companies' clinical trials; changes in relationships with strategic
partners and dependence upon strategic partners for the performance
of critical activities under collaborative agreements; and the
impact of competitive products and technological changes. These and
other factors are identified and described in more detail in
Nuvelo's filings with the SEC, including without limitation
Nuvelo's quarterly report on Form 10-Q for the quarter ended
September 30, 2008 and subsequent filings. We disclaim any intent
or obligation to update these forward-looking statements.
Additional Information and Where to Find It Nuvelo has filed a
registration statement on Form S-4, and a related proxy
statement/prospectus/consent solicitation, in connection with the
merger. Investors and security holders are urged to read the
registration statement on Form S-4 and the related proxy
statement/prospectus/consent solicitation because they contain
important information about the merger transaction. Investors and
security holders may obtain free copies of these documents and
other documents filed with the SEC at the SEC's website at
http://www.sec.gov/. In addition, investors and security holders
may obtain free copies of the documents filed with the SEC by
contacting Nuvelo Investor Relations at the email address: or by
phone at 650-517-8000. In addition to the registration statement
and related proxy statement/prospectus/consent solicitation, Nuvelo
files annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy any reports,
statements or other information filed by Nuvelo, Inc. at the SEC
public reference room at 100 F Street, N.E., Washington, D.C.
20549. Please call the SEC at 1-800-SEC-0330 for more information.
Please call the SEC at 1-800-SEC-0330 for further information on
the public reference room. Nuvelo, Inc.'s filings with the SEC are
also available to the public from commercial document-retrieval
services and at SEC's website at http://www.sec.gov/, and from
Investor Relations at Nuvelo as described above. This communication
shall not constitute an offer to sell or the solicitation of an
offer to sell or the solicitation of an offer to buy any
securities, nor shall there be any sale of securities in any
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as
amended. Nuvelo, ARCA and their respective directors and executive
officers may be deemed to be participants in the solicitation of
proxies from the stockholders of Nuvelo in connection with the
merger transaction. Information regarding the special interests of
these directors and executive officers in the merger transaction
will be included in the proxy statement/prospectus of described
above. Additional information regarding the directors and executive
officers of Nuvelo is also included in Nuvelo's proxy statement for
its 2008 Annual Meeting of Stockholders which was filed with the
SEC on April 23, 2008 and its Annual Report on Form 10-K for the
year ended December 31, 2007, which was filed with the SEC on March
12, 2008. These documents are available as described above.
DATASOURCE: Nuvelo, Inc. CONTACT: Lee Bendekgey, SVP and Chief
Financial Officer of Nuvelo, Inc., +1-650-517-8358, ; or Danielle
Bertrand of WeissComm Partners, +1-415-946-1056, Web site:
http://www.nuvelo.com/
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