Navigation Links
Nuvelo Initiates Phase 1B Clinical Trial of Anticoagulant NU172
Date:6/4/2008

- Phase 2 trial expected to begin in late 2008 or early 2009 -

SAN CARLOS, Calif., June 4 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO) today announced that it has enrolled the first patient in a single-center, Phase 1b trial to determine the safety, tolerability and pharmacokinetics of bolus plus infusion dosing of NU172, a direct thrombin-inhibiting aptamer, in approximately 30 healthy male volunteers.

"We were very encouraged by the findings of the initial Phase 1 proof-of-concept trial showing NU172's potential to address the need for rapid onset and offset of anticoagulation in the setting of medical or surgical procedures such as coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention," said Dr. Ted W. Love, chairman and chief executive officer of Nuvelo. "This Phase 1b trial will study bolus dosing followed by escalating infusion doses of NU172 for up to four hours, mimicking the drug's potential administration in CABG surgery. We will complete this trial in the third quarter of this year and anticipate moving forward with a Phase 2 study in the fourth quarter of 2008 or the first quarter of 2009."

Data from the single-center, Phase 1 trial showed that bolus doses of NU172 produced dose-dependent increases in anticoagulation, measured by activated clotting time (ACT). Upon discontinuation of NU172 the ACT showed a rapid return toward baseline with a plasma half-life of approximately 10 minutes. No serious adverse events occurred in the trial.

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 and percutaneous interventions. Data from the Phase 1 trial and preclinical studies suggest that NU172 has the potential for predictable anticoagulant effects, rapid onset and offset of action, and avoidance of thrombocytopenia.

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 in Phase 1 development for use as a potential short-acting anticoagulant during medical or surgical procedures; and preclinical candidate NU206, a Wnt pathway modulator 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, the anticipated availability of top-line data, projected operating expenses and cash usage 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 March 31, 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 Announces Positive Proof-of-Concept Data With Anticogulant NU172
2. Nuvelo Announces Preclinical Data for NU206 Demonstrating Potent Therapeutic Activity in Oral Mucositis Models
3. Nuvelo Announces Phase 2 SONOMA-3 Trial Did Not Meet Target Product Profile and Discontinues Alfimeprase Development
4. Nuvelo Initiates Phase 1 Clinical Trial of Thrombin Inhibitor, NU172
5. Nuvelo Begins Phase 2 Trial and Receives Fast Track Status for Alfimeprase in Patients With Acute Ischemic Stroke
6. Nuvelo Announces Alfimeprase SONOMA-2 Catheter Occlusion Data Presentation Webcast and Conference Call
7. Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
8. Anadys Pharmaceuticals Initiates Phase I Clinical Trial of ANA598
9. Wyeth Initiates INTORACT -- A New Clinical Trial to Examine TORISEL Plus Avastin for First-Line Treatment of Advanced Kidney Cancer
10. Human Genome Sciences Initiates First Clinical Trial of Lead IAP Inhibitor HGS1029 in Advanced Solid Tumors
11. Sunesis Pharmaceuticals Initiates Phase 2 Clinical Trial of Voreloxin (SNS-595) in Acute Myeloid Leukemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... 2017  NDS received FDA 510(k) clearance in May 2017 for ... stand specifically designed for endoscopy environments. An innovative secondary monitor solution, ... solution to support the improvement of patient outcomes, procedural efficiency, and ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... , Oct. 2, 2017  Eli Lilly and Company ... results for the third quarter of 2017 on Tuesday, ... call on that day with the investment community and ... The conference call will begin at 9 a.m. ... access a live webcast of the conference call through ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a ... has been awarded a contract by the Center for Medicare and Medicaid Services ... accelerate the enterprise use of Agile methodologies in a consistent and high value ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco dentists, ... cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated to ... breathing. Oral appliances can offer significant relief to about 75 percent of people ...
(Date:10/12/2017)... Bethesda, MD (PRWEB) , ... October 12, 2017 , ... ... Award of Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s ... 4 – 8. , In honor of Morris F. Collen, a pioneer in the ...
(Date:10/12/2017)... PA (PRWEB) , ... October 12, 2017 , ... ... is the recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B ... York City on October 11, 2017. , The annual award competition recognizes editorial and ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... first interactive health literacy software tool, and the Cancer Patient Education Network (CPEN), ... patient education, today announce a new strategic alliance. , As CPEN’s strategic ...
Breaking Medicine News(10 mins):