Data Shows Potential Treatment For Oral Mucositis Models

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Nuvelo announced preclinical data demonstrating the mechanism of action and the potent therapeutic activity of NU206 (R-spondin1) in chemotherapy or radiation-induced oral mucositis models. The data were presented in a poster session yesterday at the 2008 American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA.

The study, conducted in mouse models of oral mucositis, showed that NU206 regenerated basal layer epithelial cells and accelerated cell repair by stimulating the Wnt pathway, a signaling pathway that is critical for cell growth and differentiation during homeostasis and pathogenesis.

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"This study reinforces our belief that NU206 is a potent regenerative agent," 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 of this year, and are also assessing the therapeutic potential of other secreted proteins in the R-spondin family through our Wnt therapeutics program, which targets a range of indications where cell regeneration and differentiation are important to disease processes, including gastrointestinal disease, bone disorders, wound healing and cancer."

About NU206 and R-Spondin secreted proteins

NU206 (R-spondin1) is a recombinant, secreted protein that acts as a highly specific regulator of the gastrointestinal epithelial cell function as demonstrated in early animal studies. Preclinical studies suggest it can promote growth and repair in animal models of radiation or cancer chemotherapy induced gastrointestinal injury, as well as in animal models of inflammatory bowel disease.

The R-spondin (Rspo) family of secreted proteins are the first biologic agents that can be used to enhance endogenous Wnt signaling in vivo, and provide therapeutic potential in diseases that are dependent on the Wnt pathway for maintenance of tissue integrity and tissue repair. Rspo proteins are novel regulators of the Wnt pathway and were first identified by Nuvelo as potent gastrointestinal mitogens in transgenic mice(1).

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