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ARRA Funds Accelerating the Pace of Highly Novel Early-Stage Research in Breast Cancer

The University of Pittsburgh Cancer Institute is one of 15 universities and cancer centers participating in NCI's Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) program, an initiative that provides a vivid snapshot of economic stimulus funds at work.

Through American Recovery and Reinvestment Act (ARRA) investments, ACTNOW is funding 37 early phase clinical trials of new treatment regimens, with the hope that these new therapies will soon expand our ability to provide targeted, personalized therapies. The program has dedicated $31 million for phase I and II trials, plus $5 million for support contracts, including support to assist the investigators with data monitoring and statistical analysis.

Pittsburgh used a portion of its ACTNOW funding to hire four new researchers for its early-stage cancer drug development program, enabling the cancer center to launch or accelerate two studies of a promising new drug for women with inoperable breast cancer and ovarian cancer. Without the infusion of funds, studies of this new agent, called ABT-888, would have progressed at a significantly slower pace.

Merrill Egorin, M.D., co-director of the Molecular Therapeutics Drug Discovery Program at Pittsburgh, calls the new drug "exciting, with the potential to work wonders."

ABT-888 is part of a new class of drugs called PARP—or poly (ADP-ribose) polymerase, inhibitors—which block cancer cells' ability to repair DNA damaged by chemotherapy. NCI chose Pittsburgh's ABT-888 program for ARRA funding because previous studies there proved ABT-888 to be effective in shrinking cancerous tumors in a small number of patients. New studies will involve more patients and, it is hoped, will advance the drug to the next stage in drug development.

"Existing cancer therapies are tough to tolerate," said Dr. Egorin from his Pittsburgh laboratory. "But that's changing. Our aim is to use drugs rationally so that we maximize the likelihood of doing something good and minimize doing something bad. At our early stage of research, that requires consideration of different aspects of the drug and more importantly, of the patient."

Dr. Egorin's four new colleagues are: a new clinical research coordinator, a new regulatory specialist, a clinical research coordinator whose previous job was eliminated during the current recession, and a new laboratory technician who recently graduated in the biological sciences. The $1.45 million in ARRA funds will support these positions for two years at Pittsburgh. The cancer center plans to retain the four researchers after the ARRA funds run out, through grants and other traditional funding mechanisms that support translational research at the university. ARRA funds will also support clinical research associates at the two institutions collaborating in the studies: Penn State-Hershey and Emory University in Atlanta.

Dr. Egorin, a 5-year cancer survivor, is passionate about mentoring the next generation of cancer researchers. "I have a group of spectacularly wonderful, smart, young colleagues who all are interested in Phase 1 studies," he said. "My job is to make sure these kids work in, if you will, a greenhouse, where they can put down roots and flower."

For now, Dr. Egorin and his staff have their work cut out for them. With ARRA funding, "We've been able to hire four highly-qualified individuals. We're treating more patients than we would have otherwise and we're generating knowledge with an interesting drug that, in many respects, may revolutionize the way we treat patients."

Merrill Egorin, M.D., professor of medicine and pharmacology, University of Pittsburgh Cancer Institute (UPCI), co-director of the Molecular Therapeutics Drug Discovery Program at UPCI, and director of the Clinical Pharmacology Analytical Facility Core. Interview 9-30-09

This article originally appeared on the National Cancer Institute website.

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