SAN CARLOS, Calif., April 14 Nuvelo, Inc.(Nasdaq: NUVO) today announced preclinical data demonstrating the mechanism ofaction and the potent therapeutic activity of NU206 (R-spondin1) inchemotherapy or radiation-induced oral mucositis models. The data werepresented in a poster session yesterday at the 2008 American Association forCancer Research (AACR) Annual Meeting in San Diego, CA.
The study, conducted in mouse models of oral mucositis, showed that NU206regenerated basal layer epithelial cells and accelerated cell repair bystimulating the Wnt pathway, a signaling pathway that is critical for cellgrowth and differentiation during homeostasis and pathogenesis.
"This study reinforces our belief that NU206 is a potent regenerativeagent," said Dr. Ted W. Love, chairman and chief executive officer of Nuvelo."We are on track to begin a Phase 1 trial with NU206 in the second quarter ofthis year, and are also assessing the therapeutic potential of other secretedproteins in the R-spondin family through our Wnt therapeutics program, whichtargets a range of indications where cell regeneration and differentiation areimportant to disease processes, including gastrointestinal disease, bonedisorders, wound healing and cancer."
About NU206 and R-Spondin secreted proteins
NU206 (R-spondin1) is a recombinant, secreted protein that acts as ahighly specific regulator of the gastrointestinal epithelial cell function asdemonstrated in early animal studies. Preclinical studies suggest it canpromote growth and repair in animal models of radiation or cancer chemotherapyinduced gastrointestinal injury, as well as in animal models of inflammatorybowel disease.
The R-spondin (Rspo) family of secreted proteins are the first biologicagents that can be used to enhance endogenous Wnt signaling in vivo, andprovide therapeutic potential in diseases that are dependent on the Wntpathway for maintenance of tissue integrity and tissue repair. Rspo proteinsare novel regulators of the Wnt pathway and were first identified by Nuvelo aspotent gastrointestinal mitogens in transgenic mice(1).
Nuvelo, Inc. is dedicated to improving the lives of patients through thediscovery, development and commercialization of novel drugs for acutecardiovascular disease, cancer and other debilitating medical conditions.Nuvelo's development pipeline includes NU172, a direct thrombin inhibitor inPhase 1 development for use as a potential short-acting anticoagulant duringmedical or surgical procedures; and preclinical candidate NU206, a Wnt pathwaymodulator for the potential treatment of chemotherapy/radiationtherapy-induced mucositis and inflammatory bowel disease. In addition, Nuvelois pursuing research programs in leukemia and lymphoma therapeutic antibodiesand Wnt signaling pathway therapeutics to further expand its pipeline andcreate additional partnering and licensing opportunities.
Information about Nuvelo is available at our website athttp://www.nuvelo.com or by phoning 650-517-8000.
This press release contains "forward-looking statements," which includestatements regarding the timing, progress and anticipated completion ofNuvelo's clinical stage and research programs, the anticipated availability oftop-line data, projected operating expenses and cash usage and the potentialbenefits that patients may experience from the use of our clinical stagecompounds, which statements are hereby identified as "forward-lookingstatements" for purposes of the safe harbor provided by the Private SecuritiesLitigation Reform Act of 1995. Such statements are based on our management'scurrent expectations and involve risks and uncertainties. Actual results andperformance 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 and t