FDA-Approved Novel Anti-Cancer Agent Developed At Roswell Park For Clinical Trials

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 18 Feb 2008 - 3:00 PDT

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A novel anti-angiogenic agent, TRC105 (also known as c-SN6j), developed in the laboratory of Ben K. Seon, PhD, Department of Immunology, Roswell Park Cancer Institute (RPCI) has the potential to be an effective agent for the treatment of solid tumors. The United States Food and Drug Administration (FDA) approved TRC105 as an Investigational New Drug (IND). A phase I clinical trial, supported by government grants and sponsored by TRACO Pharmaceuticals will be performed at RPCI and three other medical centers.

Angiogenesis - the development of new blood vessels - is essential for tumor growth, progression and spread. Anti-angiogenic therapy offers promise in the treatment of cancer patients diagnosed with solid tumors. Studies conducted by Dr. Seon's group indicate that endoglin, which is expressed on endothelial cells of tumor-associated blood vessels, is essential for tumor angiogenesis and, therefore, is a useful target for anti-angiogenic therapy. TRC105 is a monoclonal antibody that targets endoglin.

In laboratory studies, the anti-endoglin agents have induced regression of established tumors by destroying preformed and developing blood vessels with limited toxicities. Dr. Seon predicts that these agents will be much more effective in treating human tumors because they react with human blood vessels much more strongly than they do with blood vessels of laboratory animals. It is anticipated that TRC105 will be tested in clinical trials of patients with breast cancer and other solid tumors to determine if this agent is effective in treating patients with advanced metastatic solid tumors.

Dr. Seon holds six patents relevant to the clinical application of anti-endoglin monoclonal antibodies. He has authored or co-authored more than 100 peer-reviewed journal articles, abstracts and book chapters. Dr. Seon, an established member of the national immunologic cancer community, is a member of American Association of Cancer Research, American Association of the Advancement of Science, the American Association of Immunologists and the American Society of Hematology.

Roswell Park Cancer Institute, founded in 1898, is the nation's first cancer research, treatment and education center and is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. RPCI is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers. Roswell Park has affiliate sites and collaborative programs in New York, Pennsylvania, and in China.

Roswell Park Cancer Institute