The pharmaceutical company GlaxoSmithKline, or GSK, has selected City of Hope as one of two sites for a clinical trial of a new drug already shown to shrink several tumor types in mice. This is one of the first such early trials sponsored by a drug company at City of Hope.
Vincent Chung, M.D., assistant professor in the Division of Medical Oncology & Therapeutics Research, is principal investigator. “GSK chose City of Hope because of our experience in conducting phase 1 clinical trials,” Chung said.
Co-investigator Tim Synold, Pharm.D., associate professor in the Department of Clinical and Molecular Pharmacology, agreed. “Being asked to conduct a ‘first in human’ study by a major pharmaceutical company recognizes that we are leaders in clinical drug development nationally,” Synold said. “A major determinant of GSK’s desire to work with us was how quickly we could get the protocol through our regulatory committees and activate the study.”
The activation process took only 60 days, a record time according to co-investigator Robert Figlin, M.D., the Arthur and Rosalie Kaplan Professor of Medical Oncology and interim director of City of Hope Comprehensive Cancer Center. “This effort illustrates how important early drug development is to City of Hope and how rapidly and effectively this research can be transferred into humans,” Figlin said.
The drug, known as GSK923295A, blocks the activity of the protein CENP-E, which is necessary for cells to divide. Other anticancer drugs also block cell division, but targeting CENP-E may be particularly effective. “Cancer cells are dividing too rapidly and make more CENP-E than normal cells,” Chung explained. “Ideally this drug should kill more cancer cells than normal cells.”
Laboratory tests in animal cancer models and cultured human tumor cells show that GSK923295A may fight several human cancers, including colon, prostate, blood and breast cancers.
The phase 1 trial is open to patients with solid tumors, non-Hodgkin’s lymphoma or chronic lymphocytic leukemia who are not responding to standard therapy. Four patients have enrolled at City of Hope. Chung noted that phase 1 trials are meant to evaluate side effects of a medication and determine the recommended dose for future clinical trials. The trial also includes a site at University of Wisconsin.
As the trial proceeds, Synold explained, patients’ tumors will be evaluated through imaging and molecular techniques to determine if phase 2 trials should begin.
“A trial like this is a high risk, high reward kind of situation,” said Synold. Not all drugs that are effective in animals work in humans, he said, but “on the other hand, sometimes you get to be the first to study a drug that will ultimately benefit patients everywhere.”