Healthcare Industry News: NAPA-2
News Release - July 6, 2006
Nuvelo Announces Publication of Phase 2 Alfimeprase Study Results in Central Venous Catheter OcclusionResults Published in Journal of Clinical Oncology
SAN CARLOS, Calif., July 6 (HSMN NewsFeed) -- Nuvelo, Inc. (Nasdaq: NUVO ) today announced the publication of Phase 2 clinical trial results in the July 1st issue of the Journal of Clinical Oncology (JCO), demonstrating that alfimeprase can quickly restore function to occluded central venous access devices (CVADs).
This Phase 2 randomized, double-blind, controlled, dose-ranging study compared the safety and activity of three fixed doses of alfimeprase (0.3 mg, 1 mg and 3 mg) against the approved dose of Cathflo®Activase® (alteplase). Fifty-five patients were treated to re-establish patency to their occluded CVADs. Catheter patency was assessed at 5, 15, 30 and 120 minutes after drug was given. If patency was not achieved at 120 minutes after the first dose of either alfimeprase or CathfloActivase, patients received a second dose. Adverse events, including bleeding events, were assessed for a 30-day period after exposure to study drug. The results demonstrated that at the highest dose of 3 mg, alfimeprase produced cumulative patency rates of 40% at 5 minutes, 50% at 15 minutes and 60% at 30 and 120 minutes after the first dose, as well as 80% at 120 minutes after the second dose. By comparison, CathfloActivase produced patency rates of 0% at 5 and 15 minutes, 23% at 30 minutes and 46% at 120 minutes after the first dose, as well as 62% at 120 minutes after the second dose. No major hemorrhagic events were reported in any treated patients.
"Restoration of CVAD function within minutes is important because it may facilitate timely delivery of prescribed therapies or enable early identification of CVAD obstructions that require prompt catheter replacement," said Steven R. Deitcher, M.D., vice president, medical sciences for Nuvelo and former principal investigator (PI) for the trial. "The ability to rapidly restore catheter function also may reduce patient anxiety related to missed or delayed treatment and improve treatment center efficiency."
"Based on these promising Phase 2 results, we have initiated two overlapping, multi-national Phase 3 trials evaluating the 3 mg dose of alfimeprase in catheter occlusion. We anticipate data from the first of these trials, the SONOMA-2 trial, in the second half of this year, and hope to confirm the ability of alfimeprase to restore function to occluded catheters in 15 minutes or less," said Ted W. Love, M.D., chairman and CEO of Nuvelo.
About the Phase 3 SONOMA Program
Nuvelo's ongoing Phase 3 clinical program evaluating alfimeprase in catheter occlusion (CO) consists of two overlapping, multi-national trials. The first trial, SONOMA-2 (Speedy Opening of Non-functional and Occluded Catheters with Mini-Dose Alfimeprase), is expected to complete enrollment in the second half of this year. This randomized, double-blind trial is comparing the efficacy of 3 mg of alfimeprase with placebo in 300 patients with occluded central venous catheters. Two-thirds of the participants are receiving alfimeprase and the remainder are receiving placebo. The primary endpoint is restoration of catheter function within 15 minutes. The second trial, SONOMA-3, began enrolling patients in February 2006 and is an open-label, single-arm trial that is evaluating the efficacy and safety of alfimeprase in restoring catheter function in 800 patients.
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, 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. Known as CO, 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. Currently, CathfloActivase is approved in the United States for restoring function to central venous catheters.
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, in clinical testing, appears to minimize bleeding side effects.
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 safety endpoints, such as the incidence of bleeding, and pharmacoeconomic endpoints, such as length of hospital and intensive care unit (ICU) stay.
In addition, Nuvelo plans to initiate a Phase 2 trial of alfimeprase for the treatment of 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 Bayer HealthCare Collaboration
In January 2006, a global collaboration was formed between Nuvelo and Bayer HealthCare (BHC) 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 four Phase 3 clinical trials for the treatment of thrombotic-related disorders; rNAPc2, an anticoagulant that inhibits the factor VIIa and tissue factor protease complex which recently completed Phase 2 clinical development in acute coronary syndromes; and a thrombin inhibiting aptamer for anticoagulation 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, the potential improvement or benefit that 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 recent annual report on Form 10-K for the year ended December 31, 2005 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
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