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Nuvelo Announces Results From Phase 3 NAPA Program In Acute Peripheral Arterial Occlusion
Nuvelo, Inc.
(Nasdaq: NUVO) announced results from the Phase 3 NAPA (Novel
Arterial Perfusion with Alfimeprase) program evaluating alfimeprase in
acute peripheral arterial occlusion (PAO). Alfimeprase is the company's
lead product candidate and is currently being studied in acute ischemic
stroke and catheter occlusion (CO). The NAPA data were presented in a
poster session by Fred Weaver, M.D., professor of surgery and associate
director of the University of Southern California Cardiovascular and
Thoracic Institute, at the 2008 International Symposium on Endovascular
Therapy (ISET), taking place this week in Hollywood, FL.
In the NAPA-2 clinical trial, the primary endpoint of 30-day open
vascular surgery avoidance was achieved in 34.9 percent of patients
receiving alfimeprase, 37.2 percent of patients receiving intra-thrombus
(IT) placebo, and 18.4 percent of patients receiving peri-thrombus (PT)
placebo. An interim analysis of the NAPA-3 study shows that 30-day open
vascular surgery avoidance was achieved in 29.4 percent of patients
receiving alfimeprase and 17.6 percent of patients receiving IT placebo.
Efficacy data from subjects with longer clots or smaller drops in alpha-2
macroglobulin, which rapidly and irreversibly inactivates alfimeprase,
suggest improved retention of alfimeprase at the site of the clot might
improve lysis. Overall adverse events (AE), as well as rates of hypotension
and peripheral embolism, were numerically higher among patients receiving
alfimeprase in both studies. However, serious adverse events (SAE), major
hemorrhage, cardiac events and infections were higher in subjects receiving
alfimeprase in NAPA-2, but were higher in subject receiving IT placebo in
NAPA-3. No intracranial hemorrhages were reported in either study.
"We continue to believe that alfimeprase is an active thrombolytic
agent when delivered in an optimized fashion, and we are focused on
developing alfimeprase in stroke and catheter occlusion," said Michael
Levy, M.D., executive vice president of research and development for
Nuvelo. "We continue to enroll patients in Phase 2 clinical trials in both
these indications and expect top-line data from the SONOMA-3 catheter
occlusion trial in the first half of 2008."
NAPA Phase 3 Program Details
The NAPA Phase 3 Program consisted of two randomized, double-blind
studies evaluating the efficacy and safety of 0.3 mg/kg of alfimeprase in
patients with acute PAO with symptom onset within 14 days. In NAPA-2,
subjects were randomized in a 4:3:1 ratio to receive IT alfimeprase
(n=149), IT placebo (n=113), or PT placebo (n=38). In NAPA-3, subjects were
randomized 1:1 between alfimeprase (n=51) and IT placebo (n=51). The
primary endpoint of both studies was avoidance of open vascular surgery
within 30 days of treatment. A variety of secondary endpoints were also
evaluated, including restoration of arterial blood flow, safety endpoints
such as the incidence of bleeding, and pharmacoeconomic endpoints such as
length of hospital and intensive care unit stay.
In addition, this call is being webcast by Thomson/CCBN and can be
accessed via Nuvelo's website at http://www.nuvelo.com. The webcast is also
being distributed through the Thomson StreetEvents Network. Individual
investors can listen to the call at http://www.earnings.com, Thomson's
individual investor portal, powered by StreetEvents. Institutional
investors can access the call via Thomson StreetEvents
(http://www.streetevents.com), a password-protected event management site.
About Alfimeprase
Alfimeprase is a recombinant direct acting fibrinolytic (rDAF) that has
the potential to rapidly dissolve blood clots through a unique mechanism of
action -- it directly degrades fibrin, a protein that provides the
scaffolding for blood clots. In addition, alfimeprase's thrombolytic
activity appears to be localized to the site of delivery because it is
rapidly inactivated by alpha-2 macroglobulin, a naturally occurring protein
in the blood, as it moves away from the site of delivery and into the
general blood circulation.
Alfimeprase is currently being evaluated in Phase 2 studies as a
potential treatment for catheter occlusion and acute ischemic stroke.
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 alfimeprase, a direct acting
fibrinolytic in Phase 2 clinical development for the treatment of
thrombotic-related disorders including acute ischemic stroke and catheter
occlusion; and preclinical candidates NU172, a thrombin inhibitor for use
as a potential direct and short-acting anticoagulant during medical or
surgical procedures; and NU206, a Wnt pathway modulator for the potential
treatment of chemotherapy/radiation therapy-induced mucositis and
inflammatory bowel disease. In addition, Nuvelo expects to continue its
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.
This press release contains "forward-looking statements," which include
statements regarding the timing and progress of Nuvelo's clinical stage and
research programs, 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; 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; stock
market conditions; the impact of competitive products and technological
changes; and uncertainties relating to our ability to obtain funding. 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 10Q for the quarter ended September 30, 2007 and subsequent
filings. We disclaim any intent or obligation to update these
forward-looking statements.
Nuvelo, Inc.
http://www.nuvelo.com
Nuvelo anunþã rezultate de la Napa program de fazã 3 în ocluzie arterialã acutã perifericã - Nuvelo Announces Results From Phase 3 NAPA Program In Acute Peripheral Arterial Occlusion - articole medicale engleza - startsanatate