Healthcare Industry News: NAPA-2
News Release - September 5, 2006
Nuvelo Announces Completion of Patient Enrollment in SONOMA-2, First Phase 3 Trial of Alfimeprase in Central Venous Catheter OcclusionSAN CARLOS, Calif., Sept. 5 (HSMN NewsFeed) -- Nuvelo, Inc. (Nasdaq: NUVO ) today announced that it has completed patient enrollment in the first Phase 3 clinical trial of alfimeprase for the treatment of central venous catheter occlusion (CO).
The Phase 3 trial, known as SONOMA-2 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase-2), is the first of two ongoing, multi-national trials in the Phase 3 alfimeprase program for CO. This randomized, double-blind trial compared the efficacy and safety of 3 mg of alfimeprase with placebo in a 2:1 ratio in approximately 300 patients with occluded central venous catheters. The study's primary endpoint is restoration of function to occluded central venous catheters at 15 minutes.
"Catheter occlusion is a widespread problem which can result in delayed administration of critical therapies such as cancer chemotherapy or antibiotics, and we are optimistic that alfimeprase will more rapidly restore delivery of these life-saving medications than existing treatments," said Steven R. Deitcher, M.D., vice president and chief medical scientist for Nuvelo and former principal investigator of Nuvelo's Phase 2 alfimeprase catheter occlusion trial. "We thank the many patients, physicians, and health care workers who participated in this trial and look forward to sharing top-line data within the next several months."
The second Phase 3 trial, known as SONOMA-3, was initiated in February 2006 and is ongoing. This open-label, single-arm trial will evaluate the safety and efficacy of 3 mg of alfimeprase in 800 patients with occluded central venous catheters.
About Catheter Occlusion
Patients with cancer and other serious diseases often receive a central venous catheter to deliver vital therapies including chemotherapy, nutritional support, pain management treatments, antibiotics and blood products, and to withdraw blood samples for testing. An estimated five million central venous catheters are placed in patients each year in the United States, and approximately 25%, or 1.25 million, become occluded by a blood clot. This obstruction in a central venous catheter can impair the ability to infuse fluid through or withdraw fluid from the catheter. Because central venous catheters are primarily inserted in patients receiving life-saving medications, it is critical to restore patency (flow) in a timely manner with minimal risk to the patient.
Alfimeprase is an enzyme produced by recombinant DNA technology that rapidly dissolves blood clots through a unique mechanism of action -- it directly degrades fibrin, a protein that provides the scaffolding for blood clots. In clinical studies, this direct mechanism of action has been shown to provide rapid clot dissolution with a well-tolerated safety profile. Alfimeprase's thrombolytic activity is 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. This clearance mechanism focuses the thrombolytic activity to the site of the clot and offers the potential to minimize bleeding side effects.
Additional Alfimeprase Trials
Alfimeprase is also being studied in two pivotal Phase 3 clinical trials, NAPA-2 and NAPA-3, for the treatment of acute peripheral arterial occlusion (PAO), or "leg attack." Both trials are randomized, double-blind studies comparing 0.3 mg/kg of alfimeprase with placebo in a total of 600 patients between the two studies. The primary endpoint in both trials is avoidance of open vascular surgery within 30 days of treatment. Open vascular surgery includes procedures such as surgical embolectomy, peripheral arterial bypass graft surgery and amputation, but does not include catheter-based procedures such as percutaneous angioplasty or stenting. A variety of secondary endpoints are also being evaluated in the two trials, including restoration of blood flow, safety endpoints, such as the incidence of bleeding and pharmacoeconomic endpoints, such as length of hospital and intensive care unit (ICU) stay. NAPA-2 completed enrollment in September 2006.
In addition, Nuvelo plans to initiate a Phase 2 trial of alfimeprase for the treatment of acute ischemic stroke in the second half of 2006 and an additional Phase 2 trial of alfimeprase for the treatment of deep venous thrombosis in 2007.
About the Collaboration
In January 2006, Nuvelo and Bayer HealthCare formed a global collaboration for the development and commercialization of alfimeprase. Under the terms of the agreement, BHC will commercialize alfimeprase in all territories outside the United States and will pay Nuvelo tiered royalties ranging from 15 to 37.5%. Nuvelo retains commercialization rights in the United States and is eligible to receive up to $385 million in milestone payments from BHC. In addition, BHC will be responsible for 40% of the costs for global development programs and Nuvelo will be responsible for 60% of the costs and will remain the lead for the design and conduct of the global development programs.
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 three acute cardiovascular programs: alfimeprase, a direct-acting thrombolytic in Phase 3 clinical trials for the treatment of thrombotic-related disorders; rNAPc2, an anticoagulant that inhibits the factor VIIa and tissue factor protease complex that recently completed Phase 2 clinical development in acute coronary syndromes; and preclinical candidate NU172, a direct thrombin inhibitor for use as a short-acting anticoagulant during medical procedures. Nuvelo is also advancing an emerging oncology pipeline, which includes NU206 for the potential treatment of chemotherapy/radiation therapy-induced mucositis, as well as rNAPc2 for potential use as a cancer therapy. In addition, Nuvelo expects to leverage its expertise in secreted proteins and cancer antibody discovery to further expand its pipeline and create additional partnering and licensing opportunities.
Information about Nuvelo is available at our website at 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 catheter occlusion trial, the potential improvement or benefit that our drugs in current and future clinical trial programs may demonstrate, and the numbers of patients who may be eligible for treatment, 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; uncertainties relating to patent protection; 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, 2006 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
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