Navigation Links
Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
Date:8/22/2007

- Revised Trial Examines Single, Higher, More Concentrated Dose of

Alfimeprase -

SAN CARLOS, Calif., Aug. 22 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO) today announced enrollment of the first patient in the SONOMA-3 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase-3) trial evaluating lead product candidate, alfimeprase, for the treatment of central venous catheter occlusion (CO).

This open-label, single-arm trial will evaluate the safety and efficacy of a single 10 milligram dose of alfimeprase with a concentration of 5 milligrams per milliliter in up to 100 patients with occluded central venous catheters.

Data from a previous Phase 3 trial in the CO program, SONOMA-2, showed that alfimeprase restored catheter function in patients with occluded catheters within 15 minutes with a p-value of 0.022. It did not however, meet the more stringent p-value required for a single pivotal trial, less than 0.00125.

"Analysis of data from our previous Phase 3 SONOMA study provided further evidence that alfimeprase is an active thrombolytic which has the potential to dissolve clots quickly and rapidly restore catheter function, however, the dose and concentration we used did not generate results in line with the target product profile we believe necessary for commercial success in this market," said Michael Levy, M.D., executive vice president of research and development for Nuvelo. "Preclinical experiments have provided evidence that increasing the concentration can result in marked improvement in thrombolytic activity. Accordingly, we are resuming development of alfimeprase in CO to evaluate the potential of a single, higher, more concentrated dose and expect data from this trial in 2008."

About Catheter Occlusion

Delivery of chemotherapy, nutritional support, antibiotics and blood products, as well as the frequent withdrawal of blood samples for laboratory testing, are often facilitated via central venous catheters. Approximately five million catheters are placed in patients in the United States each year, with as many as 25 percent becoming occluded. When a catheter becomes occluded, the goal is to restore flow in a prompt and cost-effective manner with minimal risk to the patient. As these catheters are primarily inserted in patients receiving life-saving medications such as chemotherapy, it is critical to restore flow through the catheter as soon as possible. In the case of thrombotic occlusions, treatment with thrombolytic drugs represents a less-invasive and more cost-effective alternative to replacement.

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.

In addition to catheter occlusion, alfimeprase is also being evaluated as a potential treatment for acute ischemic stroke and is in preclinical studies for acute peripheral arterial occlusion.

About Nuvelo

Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular and cancer therapy. Nuvelo's development pipeline includes alfimeprase, a direct-acting fibrinolytic for the treatment of thrombotic-related disorders including acute ischemic stroke and catheter occlusion and preclinical candidates NU206 for the potential treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease and NU172, a direct thrombin inhibitor for use as a short-acting anticoagulant during medical or surgical procedures. In addition, Nuvelo expects to leverage its expertise in cancer antibody discovery 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" regarding the timing and progress of Nuvelo's clinical programs, including the timing of the availability of data from Nuvelo's Phase 3 alfimeprase trials, the potential improvement or benefit that current and future clinical trial programs may demonstrate, and our anticipated revenues, operating expenses and net cash used in operations, 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; 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 filings with the SEC, including without limitation Nuvelo's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.


'/>"/>
SOURCE Nuvelo, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Nuvelo Announces Presentations on rNAPc2 and NU172 at the XXIst Congress of the International Society on Thrombosis and Haemostasis
2. Nuvelo Announces Publication of Phase 2 rNAPc2 Study Results in Journal of American College of Cardiology
3. Nuvelo Announces Publication of Preclinical Study Results Demonstrating the Potential of NTB-A as a New Target for Leukemia and Lymphomas
4. Nuvelo Announces Publication of NU206 Study Results in Gastroenterology
5. Nuvelo Announces Presentation on NU206 at 2007 American Association for Cancer Research Annual Meeting
6. Nuvelo Announces Presentation on rNAPc2 at American College of Cardiology 56th Annual Scientific Session
7. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
8. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
9. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
10. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
11. Gene Therapy Eradicates Pancreatic Cancer in Preclinical Trial Targeting Systems Success in Mouse Model Reported in Cancer Cell
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)...  Redwood Scientific Technologies, Inc. announced today the development ... women balance their hormones. This product will be featuring ... Jason Cardiff , President and CEO. "I am proud ... millions of women across the country and around the ... Our research and development team is confident that through ...
(Date:2/5/2016)... , Feb. 5, 2016  ivWatch, a medical devices company, ... STEM Award granted by Governor Terry McAuliffe,s office. ... on February 25th at an event to be held at ... STEM award honors professionals and business that have made significant ... Logo - http://photos.prnewswire.com/prnh/20160205/330117LOGO ...
(Date:2/5/2016)... in Alabama seeking prostate care with ... have to travel out of state. Vituro Health ... of Alabama to provide a total prostate management program ... Alabama is known throughout the ... using many different modalities. They are the largest and one ...
Breaking Medicine Technology:
(Date:2/8/2016)... MD (PRWEB) , ... February 08, 2016 , ... ... is excited to share this important news! AHCC and the Home Health and ... Coding Clinic, CMS' designee for official ICD coding guidance and clarifications, to address ...
(Date:2/8/2016)... ... 2016 , ... The schedule is now online for the largest ... which is being held May 25-29 at the Loews Chicago O’Hare Hotel, continues to ... causes of chronic illness in children. , Very recent articles have cited 1 child ...
(Date:2/7/2016)... ... 2016 , ... HealthSmart Holdings, Inc. announced today the launch ... and information to lower the costs, and increase the impact of their healthcare ... healthcare benefits by as much as 22%:, + Price and quality transparency, ...
(Date:2/6/2016)... ... ... With the FCPX LUT: Summer pack from Pixel Film Studios, ... is a Lookup Table that contains a mathematical formula for modifying an image. The ... manipulating each pixel, LUT's can change each color range differently, it gives the user ...
(Date:2/5/2016)... ... February 05, 2016 , ... Love is in the ... a variety of colors, assortments and packaging. This staple for Valentine’s Day is a ... location. , For Valentine’s Day, not only are long-stem roses available, but also ...
Breaking Medicine News(10 mins):