Healthcare Industry News: Bayer HealthCare
News Release - September 5, 2006
Nuvelo Announces Completion of Patient Enrollment in NAPA-2, First Phase 3 Trial of Alfimeprase in Acute Peripheral Arterial 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 acute peripheral arterial occlusion (PAO), or "leg attack."
The Phase 3 trial, known as NAPA-2 (Novel Arterial Perfusion with Alfimeprase-2), is the first of two multi-national trials in the Phase 3 alfimeprase program for acute PAO. This randomized, double-blind study compared the efficacy and safety of 0.3 mg/kg of alfimeprase versus placebo in approximately 300 patients in over 100 centers worldwide. The study's primary endpoint is avoidance of open vascular surgery within 30 days of treatment. Open vascular surgery includes procedures such as surgical embolectomy and peripheral arterial bypass graft surgery as well as amputation, but does not include catheter-based procedures such as percutaneous angioplasty or stenting. A variety of secondary endpoints are also being evaluated, including restoration of arterial blood flow, safety endpoints such as the incidence of bleeding and pharmacoeconomic endpoints such as length of hospital and intensive care unit (ICU) stay.
"We'd like to thank the patients, investigators, and coordinators at our trial sites for helping us to reach this important milestone," said Michael D. Levy, M.D., senior vice president, research and development for Nuvelo. "We look forward to announcing top-line data within the next several months and are hopeful that these data will confirm our Phase 2 study, which demonstrated the ability to restore arterial blood flow within four hours of initiation of dosing with a favorable safety profile."
The second Phase 3 trial, known as NAPA-3, was initiated in April 2006 and is ongoing. This trial essentially replicates the NAPA-2 study design and is being conducted under a special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
In addition, the FDA granted alfimeprase fast track designation for the treatment of acute PAO, which can potentially facilitate development and expedited review of a Biologics License Application (BLA). Fast track designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and are intended for the treatment of a serious or life-threatening condition. Alfimeprase also has received orphan drug designation from both the FDA and the Committee for Orphan Medicinal Products of the European Medicines Agency for the treatment of acute PAO.
About Leg Attack
Acute PAO, or "leg attack," occurs when a blood clot blocks arterial blood flow to a lower limb. Affecting more than 100,000 people in the United States each year, acute PAO is the result of underlying peripheral arterial disease, in which chronic plaque buildup restricts blood flow and is then complicated by the formation of an acute clot. If blood flow is not restored, leg attack can lead to permanent nerve and muscle damage, gangrene and, in the most severe cases, amputation and death.
Currently, because there are no FDA-approved thrombolytic therapies available to treat acute PAO, off-label use of plasminogen activators often occurs. As noted in published studies, plasminogen activators may require a prolonged infusion averaging 24 to 36 hours in patients with acute PAO, carry the risk of significant bleeding complications and typically require admission to the ICU for the duration of the infusion.
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
In addition to acute PAO, alfimeprase is being studied in an ongoing Phase 3 clinical program known as the SONOMA (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase) program, for the treatment of catheter occlusion. The program consists of two multi-national trials. The first trial, SONOMA-2, is an efficacy study comparing 3 mg of alfimeprase versus placebo in 300 patients with occluded central venous catheters, evaluating restoration of function to the catheters at 15 minutes. SONOMA-2 completed enrollment in September 2006. The second trial, SONOMA-3, is an open label, single-arm trial evaluating alfimeprase in 800 patients. This study's primary endpoint is safety; however efficacy will also be evaluated. SONOMA-3 began enrollment in February 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 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, Bayer 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 Bayer. In addition, Bayer 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 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, including the timing of the availability of data from Nuvelo's Phase 3 alfimeprase peripheral arterial occlusion trial and the potential improvement or benefit that current and future clinical trial programs may demonstrate, 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.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.