NEW JOINT PROGRAM ANNOUNCED BY FDA AND NCI HOLDS PROMISE FOR CANCER

"This new approach to treatment holds the potential to revolutionize cancer detection and care," said Health and Human Services Secretary Tommy G. Thompson. "With this expanded collaboration, the FDA and NCI are employing powerful, new technologies they developed jointly." The agency collaboration began in 1997 and is led by Emanuel Petricoin, Ph.D., of FDA's Center for Biologics Evaluation and Research (CBER), and Lance Liotta, M.D. Ph.D., of NCI's Center for Cancer Research.

The new Clinical Proteomics Program, funded for three years with $1.1 million per year, begins in the laboratory with recently developed tools capable of rapidly scanning cells for hundreds of proteins at once. Petricoin and Liotta have also created new technologies to generate protein fingerprints that may provide early warning of drug side effects. In addition, they have already invented or refined several key technologies used in proteomic analysis.

"The great challenge now in proteomics research is to begin to apply these technologies to clinical care," said Petricoin. "We hope to take these techniques out of the lab to assess their benefit for people with cancer, in a true bench-to-bedside clinical research program."

"The potential payoffs for this program are great, said Liotta. "Everything we learn while refining these cutting-edge technologies will benefit cancer patients and the people trying to help them.

Potential benefits include:

• developing individualized therapies using targeted treatments that have been predetermined to be effective for each patient;
  
• determining the toxic and beneficial effects of treatments first in the lab before using them in patients;
• diagnosing cancer earlier than is now possible;
• improving the understanding of tumors at the protein level, leading to better treatments.

Petricoin and Liotta have identified more than 130 proteins in cancers of the breast, ovary, prostate, and esophagus that change in amount as the cells in these tissues grow abnormally, which may provide new means of diagnosing and treating cancers earlier.

The first step to take these techniques out of the lab to benefit patients has begun with the new FDA/NCI collaborative program. Through the Clinical Center at NIH, biopsied cells from cancer patients before and after treatment are extracted using a special microscope invented in Liotta's laboratory. The microscope allows them to isolate pure normal cells, pre-cancerous cells, and tumor cells from the same patient. By capturing cells directly from the tissue, the original protein pattern of the cells is maintained, which is not the case with traditional methods of isolating cells.

Next, the scientists are analyzing the patterns of proteins in the extracted tumor cells after the patient has been treated. For instance, the researchers are trying to determine how a particular treatment changes the pattern of the proteins in a cell or whether the protein patterns change if the tumor returns after treatment.

The NCI has recently begun clinical trials using proteomics to help make decisions about the course of the patients' experimental treatments.

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