Nuvelo Initiates Phase 1 Clinical Trial of NU206 in Healthy Volunteers
29 Juillet 2008 - 2:30PM
PR Newswire (US)
SAN CARLOS, Calif., July 29 /PRNewswire-FirstCall/ -- Nuvelo, Inc.
(NASDAQ:NUVO) today announced that it has enrolled the first
subject in a single-center, Phase 1 trial of recombinant, secreted
protein, NU206, the company's lead compound from its Wnt
Therapeutics Program. This double-blind, placebo-controlled,
single-ascending dose (SAD) trial will determine the safety,
tolerance and pharmacokinetics of a single intravenous (IV)
administration of NU206, in approximately 48 healthy male
volunteers. Participants will be enrolled in up to six cohorts of
varying doses, with a maximum dose of 0.80 mg/kg. "The initiation
of this healthy volunteer trial, coupled with the Phase 1b
multiple-ascending dose study that will start later this year or
early next year, allows us to accelerate NU206 development," said
Dr. Ted W. Love, chairman and chief executive officer of Nuvelo.
"Due to its ability to promote cell growth and repair in
preclinical studies, we believe NU206 has the potential to offer a
novel approach for the treatment of serious medical conditions
including gastrointestinal (GI) injury, inflammatory bowel disease
and bone disease. The two healthy volunteer trials will provide
useful insight for the multiple indications that we plan to
investigate with NU206." 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, bone disease and wound healing. About Nuvelo and
Kirin's Joint Collaborative Effort Scientists from Nuvelo and 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 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% (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 in 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 our website at http://www.nuvelo.com/ or by phoning
650-517-8000. This press release contains "forward-looking
statements," which include statements regarding the timing,
progress and anticipated completion of Nuvelo's clinical stage and
research programs, and the potential benefits that patients may
experience from the use of our clinical stage compounds, 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,
uncertainties relating to drug discovery and the regulatory
approval process; clinical development processes; enrollment rates
for patients in our 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 June
30, 2008 and subsequent filings. We disclaim any intent or
obligation to update these forward-looking statements. DATASOURCE:
Nuvelo, Inc. CONTACT: Nicole Foderaro, +1-415-946-1058, , or
Danielle Bertrand, +1-415-946-1056, , both of WeissComm Partners,
for Nuvelo, Inc. Web site: http://www.nuvelo.com/
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