Release Details

October 12, 2006

New therapy reverses resistance to chemotherapy

CLEVELAND—Case Western Reserve University’s Technology Transfer Office has entered a worldwide exclusive licensing agreement with TRACON Pharmaceuticals of San Diego, Calif., to develop Methoxyamine, a new cancer therapeutic that reverses cancer cell resistance to chemotherapy. Methoxyamine is a “first in class” drug that targets a specific DNA repair pathway.

TRACON Pharmaceuticals is an emerging biotechnology company focused on identifying, developing and commercializing targeted therapies for cancer and angiogenesis. TRACON’s management team couples their ability to execute with their extensive knowledge of oncology drug development and first generation targeted therapies, enabling them to advance the development of next generation cancer therapies.

Methoxyamine was developed by University Hospitals Case Medical Center researchers Stanton Gerson, M.D., director of the National Cancer Institute-designated Case Comprehensive Cancer Center and University Hospitals Ireland Cancer Center, and Lili Lui, Ph.D., assistant professor of medicine in the department of hematology and oncology at the Case School of Medicine. They were the first to show the therapeutic potential of Methoxyamine as an anti-cancer drug in combination with other agents.

“We are very excited about the potential of this new drug. The promise of overcoming a major mechanism of drug resistance in cancer is terrific news for many patients. We see potential applications in patients with brain cancers, melanoma, lung cancer and leukemias and perhaps other cancers,” said Gerson.

Under the licensing agreement, TRACON will develop and manage clinical trials of Methoxyamine. “We are excited to be able to develop Methoxyamine. Chemotherapy represents the most commonly used class of agents to treat cancer patients. Unfortunately, resistance of cancer cells to chemotherapy prevents many patients from benefiting. Methoxyamine’s unique ability to reverse resistance to chemotherapy could improve the lives of the many patients treated with chemotherapy each year,” noted Charles Theuer, M.D., Ph.D., president and CEO of TRACON.

Research for this new therapeutic evolved from the researchers’ project in the National Institutes of Health Rapid Access to Interventional Development (RAID) program that provides researchers resources and support needed for the development of new therapeutics. The NIH RAID program focuses on a subset of small molecules, including new agents that improve the activity of established chemotherapeutics.

The patented therapy, which has been licensed to TRACON, has been studied most intensively in combination with the approved chemotherapeutic Temozolomide. Methoxyamine prevents cancer cells from repairing DNA damage caused by chemotherapy, according to Steve Tan, a senior licensing manager in Case’s Tech Transfer Office.

According to Michael Haag, director of biomedical licensing in Case’s Tech Transfer Office, Methoxyamine could improve the anti-cancer activity of many chemotherapeutic agents, including those used for solid tumors and hematologic malignancies.

About TRACON
TRACON was established in 2005, with a focus on targeted cancer therapies (TaRgeted Approach and Control in Oncology) .

Charles P. Theuer, M.D., Ph.D., serves as president and CEO. Theuer joined TRACON after developing pharmaceuticals for TargeGen Inc, a company that develops small molecule kinase inhibitors in oncology, ophthalmology and cardiovascular disease, and Pfizer where he led the clinical development of Sutent® in kidney cancer.

Case Western Reserve University is among the nation’s leading research institutions. Founded in 1826 and shaped by the unique merger of the Case Institute of Technology and Western Reserve University, Case is distinguished by its strengths in education, research, service, and experiential learning. Located in Cleveland, Case offers nationally recognized programs in the Arts and Sciences, Dental Medicine, Engineering, Law, Management, Medicine, Nursing, and Social Work. http://www.case.edu.

About University Hospitals
With 150 locations throughout Northeast Ohio, University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our Health System is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated Rainbow Babies & Children's Hospital, ranked best in the Midwest and first in the nation for the care of critically ill newborns; MacDonald Women's Hospital, Ohio's only hospital for women; and Ireland Cancer Center, which holds the nation's highest designation by the National Cancer Institute of Comprehensive Cancer Center. For more information, go to www.uhhospitals.org

University Hospitals Ireland Cancer Center and Case Western Reserve University partner as the National Cancer Institute (NCI) designated Case Comprehensive Cancer Center. This means that the Ireland Cancer Center has met standards of excellence established by NCI for research and clinical care. The Ireland Cancer Center provides a full spectrum of state-of-the-art cancer care and services; High quality, integrated research activities from basic to clinical to prevention and control research; Information services to the public; Education and training for health research and health care professionals; and Various other outreach activities which impact on the communities and region that the Cancer Center services.