Navigation Links
Nuvelo Announces Positive Phase 1b Proof-of-Concept Data With Anticoagulant NU172

- Phase 2 development to begin in late 2008 or in early 2009 -

SAN CARLOS, Calif., Aug. 14 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO) today announced positive results from the Phase 1b proof-of-concept trial of NU172, demonstrating that the direct thrombin inhibitor rapidly produced and maintained anticoagulation with a rapid return toward baseline after the infusion ended with a favorable safety profile.

"NU172 has the potential to address many of the limitations of currently available anticoagulants given the profile we have seen to date in preclinical and Phase 1 testing, including its ability to produce rapid and predictable onset and offset of anticoagulation without the need for an antidote, its potential ability to work in stagnant blood, its predominately non-renal clearance, and the option to stop and restart anticoagulation as needed during or after surgery," said A. Michael Lincoff, M.D., vice chairman of the department of cardiovascular medicine and an interventional cardiologist at the Cleveland Clinic. "Because of these characteristics, NU172 could potentially offer an improved approach to anticoagulation for procedures such as coronary artery bypass graft (CABG) surgery, kidney dialysis, and percutaneous coronary intervention (PCI)."

The single-center, Phase 1b trial examined the safety, tolerability and pharmacokinetics of intravenous bolus plus infusion dosing of NU172, in 24 healthy male volunteers. Volunteers were given a 2 mg/kg bolus dose followed by escalating infusion doses of NU172 for four hours. In all four cohorts, NU172 produced dose-dependent increases in anticoagulation, measured by activated clotting time (ACT), prothrombin time (PT) and activated partial thromboplastin time (aPTT). The highest infusion dose rate tested, 6.0 mg/kg/hr, resulted in an average ACT per subject ranging from 373 to 414 seconds and an increase of approximately three times baseline. Average PT values per subject ranged from 56 to 92 seconds and had an increase of approximately five times baseline. Average aPTT values per subject ranged from 130 to 178 seconds and had an increase of approximately five times baseline. All measurements were maintained stably throughout the four-hour infusion. Once the infusion ended, the ACT and other coagulation parameters showed a rapid return toward baseline, consistent with the short plasma half-life of NU172 observed in the Phase 1a trial. In addition, NU172 was well-tolerated with no serious adverse events.

"In this study, we were able to identify a dose that meets or exceeds the level of anticoagulation needed for the indications we plan to evaluate, including CABG surgery," said Dr. Ted W. Love, chairman and chief executive officer of Nuvelo. "In addition to supporting our previous proof-of-concept data, the Phase 1b study shows that anticoagulation with NU172 can be maintained for four hours, which is longer than a typical CABG procedure. We are on track to launch a Phase 2 study evaluating NU172 in the fourth quarter of 2008 or the first quarter of 2009."

Approximately 450,000 CABG procedures, 50 million dialysis procedures, and 1.2 million PCIs are performed annually in the U.S. During these procedures, anticoagulants are given to prevent blood clotting. In CABG procedures and often in dialysis, the anticoagulation effect of heparin must be reversed with protamine once the procedure has been completed.

About Aptamers and NU172

Aptamers are chemically synthesized single-stranded nucleic acids that form well-defined three-dimensional shapes, allowing them to bind target molecules in a manner that is conceptually similar to antibodies. Characteristics of aptamers include high specificity and affinity, and the ability to target protein-protein interactions.

NU172 is an aptamer designed to directly inhibit thrombin's ability to stimulate blood clot formation in the setting of medical procedures where human blood is exposed to foreign materials. Specifically, NU172 is being studied for use as a potential short-acting anticoagulant during procedures such as coronary artery bypass graft surgery, kidney dialysis and percutaneous coronary interventions. Data from the Phase 1 trial and preclinical studies suggest that NU172 has the potential to produce rapid and predictable onset and offset of anticoagulation, work in stagnant blood, avoid thrombocytopenia, and has the potential for non-renal clearance.

About Nuvelo and Archemix's Joint Collaborative Effort

In August 2006, Nuvelo expanded its collaboration with Archemix to develop and commercialize aptamers that have a short-acting anticoagulant effect. Under the agreement, Archemix is responsible for discovery of short-acting aptamers for use in medical procedures, and Nuvelo leads development and worldwide commercialization of these aptamers.

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 our website at 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.

SOURCE Nuvelo, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Nuvelo Initiates Phase 1B Clinical Trial of Anticoagulant NU172
2. Nuvelo Announces Positive Proof-of-Concept Data With Anticogulant NU172
3. Nuvelo Announces Preclinical Data for NU206 Demonstrating Potent Therapeutic Activity in Oral Mucositis Models
4. Nuvelo Announces Phase 2 SONOMA-3 Trial Did Not Meet Target Product Profile and Discontinues Alfimeprase Development
5. Nuvelo Initiates Phase 1 Clinical Trial of Thrombin Inhibitor, NU172
6. Nuvelo Begins Phase 2 Trial and Receives Fast Track Status for Alfimeprase in Patients With Acute Ischemic Stroke
7. Nuvelo Announces Alfimeprase SONOMA-2 Catheter Occlusion Data Presentation Webcast and Conference Call
8. Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
9. NewCardio Announces Positive Results From Third Clinical Validation Study
10. Medarex Announces Initiation of Phase 2 Clinical Development Program for the Treatment of Lupus
11. Lixte Biotechnology Holdings Announces Filing of a New Patent Application for the Use of Novel Compounds as Potential Treatment for Neurodegenerative Diseases
Post Your Comments:
(Date:11/26/2015)... -- 3D bioprinting market is expected to ... report by Grand View Research Inc. Rising prevalence of chronic ... transplantation is expected to boost the market growth, as 3D ... --> 3D bioprinting market is expected to ... report by Grand View Research Inc. Rising prevalence of chronic ...
(Date:11/26/2015)... 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in the ... Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new 247-page ... therapeutic drug monitoring market, including emerging tests, technologies, ...
(Date:11/26/2015)... 26, 2015 ... "2016 Future Horizons and Growth Strategies ... Market: Supplier Shares, Country Segment Forecasts, Competitive ... offering. --> ) has ... Future Horizons and Growth Strategies in the ...
Breaking Medicine Technology:
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... offering factory direct sauna parts and accessories. , Sauna accessories help improve ... the bather’s style and personality. From basic styles for the purist looking for ...
(Date:11/25/2015)... ... November 25, 2015 , ... On November 10, 2015, ... District Court of Connecticut on behalf of a home health care worker who provided ... or former home health care workers employed by Humana, Inc., Humana at Home, Inc., ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... across the country to celebrate their sobriety and show through pictures what a ... and after” photos this Thanksgiving with the hashtag #FacesOfGratitude on their Facebook, Twitter, ...
(Date:11/25/2015)... ... November 25, 2015 , ... Wimbledon Health ... launches new Wimbledon Athletics Facebook page to educate the public, parents ... cardiac abnormalities. About 2,000 people under the age of 25 die from sudden ...
(Date:11/25/2015)... ... November 25, 2015 , ... Smiles by Stevens is ... and moderate facial wrinkling. While many patients are aware of the benefits of Botox® ... Botox® delivers to those suffering with discomfort, soreness, and pain as a result of ...
Breaking Medicine News(10 mins):