Nuvelo Announces Publication of NU206 Study Results inGastroenterology
SAN CARLOS, Calif, April 11, 2007 /PRNewswire-FirstCall/ -- Nuvelo, Inc. today announced the publication of data from a study of NU206 (R-Spondin1), a secreted protein currently in preclinical development, showing that it acts as a specific and potent stimulator of gastrointestinal (GI) epithelial cells. This epithelial lining is damaged in patients with inflammatory bowel conditions, including Crohn's disease and ulcerative colitis. The study, entitled "R-Spondin1, A Novel Intestinotrophic Mitogen, Ameliorates Experimental Colitis in Mice," appears in the April issue of Gastroenterology, the official journal of the American Gastroenterological Association (AGA).
"This study lays the scientific foundation for the development of NU206 as a potential treatment for inflammatory bowel disease," said Walter Funk, Ph.D., vice president of research for Nuvelo. "In multiple animal disease models, NU206 was shown to decrease the severity of chronic colitis by restoring the epithelial lining and alleviating inflammation of the small intestine and colon. In addition, treatment with NU206 reduced the physiological symptoms of colitis, including weight loss, diarrhea, and rectal bleeding."
The study investigated the efficacy of NU206 in reducing the severity of colitis induced by dextran sulfate sodium (DSS), trinitrobenzene sulfonic acid (TNBS), and by non-steroidal anti-inflammatory drug (NSAID) treatment in interleukin (IL)-10-deficient mice.
NU206, also known as human R-spondin1, is a recombinant, secreted protein that has the potential to act as a potent and highly specific growth factor of GI epithelial cells. In early animal model studies, NU206 promoted growth and repair of these tissues in models of radiation treatment or chemotherapy, as well as in animal models of inflammatory bowel disease and short bowel syndrome. A publication in the August 2005 issue of Science described results from studies in animal models of mucositis, where NU206 was shown to diminish symptoms of mucositis, including diarrhea and weight loss.
Scientists from Nuvelo and Kirin worked together to identify and characterize NU206 as part of a collaboration focused on the discovery of novel, secreted proteins. NU206 is the first compound to enter preclinical studies from this program. Nuvelo signed a collaboration agreement with Kirin in April 2005 to develop NU206. Under the agreement, Nuvelo leads worldwide development, manufacturing and commercialization and all operating expenses and profits related to the development and commercialization of NU206 are shared 60% (Nuvelo)/40% (Kirin).
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 for the treatment of thrombotic-related disorders which is suspended pending review and analysis of clinical data; rNAPc2, an anticoagulant that inhibits the factor VIIa and tissue factor protease complex that completed Phase 2 clinical development in acute coronary syndromes; and preclinical candidate NU172, a direct thrombin inhibitor for use as a short- acting anticoagulant during medical or surgical procedures. Nuvelo is also advancing an emerging oncology pipeline, including rNAPc2 which is in Phase 2 testing for potential use as a cancer therapy, as well as NU206 a preclinical candidate for the potential treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease. 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.
Kirin Brewery's Pharmaceutical Division is committed to providing innovative pharmaceuticals to patients in the field of kidney diseases, cancer (including hematological disorders), immunological diseases, and infectious diseases by using its unique and strong biotechnology. Kirin Brewery's Pharmaceutical Division has established operations in Asian countries and will expand globally including North America and Europe as a specialty pharmaceutical company. For more information on Kirin Brewery's Pharmaceutical Division, please visit its website at http://www.kirin.co.jp/english/index.html.
This press release contains "forward-looking statements," which include statements regarding the potential uses of NU206 to treat various conditions, the timing and progress of Nuvelo's clinical stage and preclinical research programs, and the potential utility of other Nuvelo compounds to treat particular indications, 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; and dependence upon strategic partners for the performance of critical activities under collaborative agreements. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo's Annual Report on Form 10-K for the year ended December 31, 2006 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
Posted: April 2007