Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular disease, cancer and other debilitating medical conditions. Nuvelo’s development pipeline includes alfimeprase, a direct acting thrombolytic in Phase 2 clinical development for the treatment of thrombotic-related disorders including acute ischemic stroke and catheter occlusion (CO); 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 potential short-acting anticoagulant during medical or surgical procedures. In addition, Nuvelo expects to continue its research programs in leukemia therapeutic antibodies and Wnt signaling pathway therapeutics to further expand its pipeline and create additional partnering and licensing opportunities.
Our lead candidate, alfimeprase, is a recombinant direct acting fibrinolytic (rDAF), or blood clot dissolver. It has the potential to rapidly and directly degrade fibrin, a protein that provides the scaffolding for blood clots, when delivered through a catheter to the site of a blood clot. 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. Nuvelo has re-initiated the SONOMA-3 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase) clinical trial to evaluate the efficacy and safety of alfimeprase in patients with CO and expects top-line data from this trial in the first half of 2008. Nuvelo plans to initiate the Phase 2 CARNEROS-1 (Catheter Directed Alfimeprase for Restoration of Neurologic Function and Rapid Opening of Arteries in Stroke) proof-of-concept trial with alfimeprase in acute ischemic stroke in the second half of 2007.
Our second drug candidate, NU206 (R-spondin1), is a recombinant, secreted protein that acts as a highly specific regulator of the gastrointestinal epithelial cells as demonstrated in early animal studies. Preclinical studies suggest it can promote growth and tissue repair in animal models of radiation or cancer chemotherapy induced gastrointestinal injury, as well as in animal models of inflammatory bowel disease. We expect to begin a Phase 1 trial of NU206 in the first half of 2008.
NU172, an aptamer designed to directly inhibit thrombin's ability to stimulate blood clot formation, is our third drug candidate. Data from early animal models suggest that NU172 is an anticoagulant that has the potential for predictable anticoagulant effects, rapid onset and offset of action, and avoidance of heparin-induced thrombocytopenia. NU172 is currently being evaluated in IND-enabling studies and we expect to enter a Phase 1 trial in late 2007 or the first quarter of 2008. Nuvelo expects to provide data from this proof-of-concept trial in 2008.
In addition to clinical and development-stage drug candidates, Nuvelo has an active research effort focused on identifying novel drug candidates through its Wnt Therapeutics and Leukemia Therapeutic Antibody programs. Through the Wnt therapeutics program, Nuvelo has identified several drug candidates including the lead candidate in this program, NU206, a Wnt regulator also known as R-Spondin1 (RSpo1). The Wnt therapeutics program targets a broad range of indications where cell regeneration and differentiation are important to disease processes, such as gastrointestinal disease, bone disorders, wound healing and cancer. Nuvelo is also developing monoclonal antibody (mAbs) candidates discovered by its leukemia therapeutic antibody program, and is completing preclinical studies with a series of chimeric mAbs to select drug candidates for the treatment of chronic lymphocytic leukemia and acute mylogenous leukemia.
Last Updated: 11-26-2007