THOUSAND OAKS, Calif., April 19 /PRNewswire-FirstCall/ -- Amgen today announced results of a preclinical study demonstrating a positive response to administration of RANK-Fc against mammary tumor formation in mouse models. OPG-Fc and RANK-Fc bind to and block the action of RANKL. These molecules have a comparable mechanism of action to denosumab. The study was presented today in a late-breaking abstract at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010 in Washington, D.C.
Using a hormone (MPA) and carcinogen (DMBA)-induced mammary tumor model in wild-type (WT) mice, the study showed that treatment with RANK-Fc at the initiation of DMBA treatment delayed the time to mammary tumor formation vs. control-treated mice (P<0.0001). RANK-Fc treatment also decreased the incidence of palpable mammary tumors at 32 weeks post last DMBA (22 percent in RANK-Fc treated mice vs. 94 percent in control-treated mice).
“In this preclinical study, RANKL inhibition reduced mammary tumor formation in hormone-dependent mouse models,” said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. “These studies suggest that RANKL inhibition might also prove effective in the treatment of human malignancy. We are encouraged by these results, which could ultimately prove important for patients with breast cancer.”
RANKL and its target receptor RANK are key factors in bone remodeling and bone destruction associated with bone metastasis. Denosumab, a fully human monoclonal antibody that specifically inhibits RANKL, inhibits osteoclastogenesis and osteoclast-mediated bone destruction.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
The scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
(Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO )
Photo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.comAmgen
