SAN CARLOS, Calif., Jan. 9 /PRNewswire-FirstCall/ -- Nuvelo Inc. today will provide updated 2006 clinical guidance at the JPMorgan 24th Annual Healthcare Conference in an 8:30 a.m. PST presentation by Ted W. Love, MD, Nuvelo's chairman and chief executive officer.
The Company recently announced a collaboration agreement with Bayer HealthCare AG (BHC) to maximize the global development and commercialization of alfimeprase, its lead Phase 3 product candidate. Alfimeprase is a novel, first-in-class, direct-acting thrombolytic, or clot dissolver, that has been shown in clinical studies to provide rapid clot dissolution with a favorable safety profile. Thrombosis, or clot formation in the blood vessels, is the leading cause of morbidity and mortality in the Western world. Nuvelo is developing alfimeprase with the goal of changing the treatment paradigm for a wide range of conditions due to thrombosis, including acute peripheral arterial occlusion (PAO), catheter occlusion (CO), stroke and deep venous thrombosis (DVT).
In today's presentation, the Company will provide updated guidance as follows:
Patient Enrollment in Alfimeprase Phase 3 Programs in Acute PAO and CO
The Company expects to complete patient enrollment in the second half of 2006 in two ongoing Phase 3 trials with alfimeprase: NAPA-2 (Novel Arterial Perfusion with Alfimeprase-2), the first of two Phase 3 trials for the treatment of acute PAO and SONOMA-2 (Speedy Opening of Non-Functional and Occluded Catheters with Mini-Dose Alfimeprase-2), the first of two Phase 3 trials for the treatment of CO. Nuvelo will initiate a second Phase 3 trial with alfimeprase in acute PAO (NAPA-3) in early 2006 and a second Phase 3 trial in CO (SONOMA-3) in the first half of 2006.
Pipeline Expansion: Cardiovascular Disease and Cancer
Nuvelo plans to expand the alfimeprase clinical development program by initiating a Phase 2 clinical trial for the treatment of stroke in the second half of 2006 and a Phase 2 clinical trial for the treatment of DVT in 2007.
The Company also plans to expand the clinical development program for its second drug candidate, rNAPc2, an inhibitor of the factor VIIa/tissue factor protease complex. This complex has been shown to play a role in the cellular signaling of both metastasis and angiogenesis in a variety of cancers. The Company plans to investigate the role of rNAPc2 as a potential cancer therapy in 2006. In addition, Nuvelo plans to complete its Phase 2 heparin replacement trial in the first half of 2006, investigating the role of rNAPc2 as an anticoagulant in patients with acute coronary syndrome.
Further expanding its oncology pipeline, Nuvelo is developing NU206, a novel and potent growth factor that is a highly specific stimulator of the epithelial cells that line the gastrointestinal tract, to reduce cancer therapy induced mucositis. The Company expects to initiate a Phase 1 clinical trial with NU206 in the second half of 2006. Gastrointestinal mucositis is a condition that causes extreme discomfort in patients undergoing radiation therapy or chemotherapy, and there are few treatment options available.
"We intend to develop and commercialize best- and first-in-class compounds that have the potential to transform treatment paradigms in cardiovascular disease and cancer," said Ted W. Love, M.D., chairman and chief executive officer of Nuvelo. "Through our focused research and development efforts, we are building a strong portfolio of products that address multiple indications, increasing the probability of success and the market opportunity for each of our compounds."
Webcast Information
An audio webcast of the JPMorgan presentation is available online at http://equityconferences.jpmorgan.com or via the Investor Relations portion of Nuvelo's website at http://www.nuvelo.com.
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 clinical pipeline includes alfimeprase, a direct-acting thrombolytic in Phase 3 trials for the treatment of thrombotic-related disorders, and rNAPc2, an anticoagulant that inhibits the factor VIIa/tissue factor complex that is currently in Phase 2 clinical development for acute coronary syndrome. Nuvelo is also progressing its preclinical development candidate, NU206, for the potential treatment of cancer therapy-induced mucositis. 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 company's anticipated use of cash in the fiscal year 2006, the timing and amounts that the company anticipates receiving under collaborative agreements, the progress of the company's clinical programs, the potential benefits of compounds under development, and the potential markets for those 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; 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, 2004 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
Nuvelo, Inc.CONTACT: Nicole Estrin, Associate Director of Corporate Communications &IR, +1-650-517-8472, nestrin@nuvelo.com; or Carolyn Bumgardner Wang,WeissComm Partners, Inc., +1-415-946-1065, carolyn@weisscommpartners.com
Web site: http://www.nuvelo.com/
