University of Maryland, Aug. 3, 2000 — The University of Maryland Greenebaum Cancer Center will be participating in a Phase III clinical trial of an experimental drug for leukemia known as STI-571. Manufactured by Novartis Pharmaceuticals Corp, STI-571 has shown so much promise in initial testing that the U.S. Food and Drug Administration has fast-tracked the testing process.

“We don’t know for how long, but it seems to be effective, and we don’t see a down side based on the initial testing,” said Stanley Frankel, M.D., director of clinical studies at the University of Maryland Greenebaum Cancer Center and an associate professor of medicine at the University of Maryland School of Medicine, who anticipates an immediate interest from the patient community.

"We don’t know for how long, but it seems to be effective, and we don’t see a down side based on the initial testing."

STI-571 is being studied to treat chronic myelogenous leukemia (CML), a common form of leukemia that can go from a chronic phase with very few symptoms for three to four years before progressing into a rapidly fatal “blast crisis” phase that kills most patients within a year.

Medical researchers have expressed enthusiasm that the experimental drug, an orange pill taken daily, may be a potent weapon to combat leukemia and one of the most effective in a new class of “cytostatics” that stop cancer in its tracks by targeting only cancer cells without harming healthy ones.

In initial testing, STI-571 led to a 95 percent remission rate in CML patients in the early stages of the disease. In the Phase I trials, the blood counts of 57 of 59 patients rapidly returned to normal and one out of three showed significant drops in the actual number of defective chromosomes responsible for the onset of CML.

STI-571 is being tested now to monitor its effectiveness against CML compared to alpha interferon, the only alternative drug currently available to halt the progression of the disease and one that has shown only limited success.

Though more testing needs to be performed, word-of-mouth spread rapidly due to the Internet and patients worldwide have lobbied for quicker accessibility to STI-571.

Because the disease has a high mortality rate once it has progressed beyond the initial chronic stage, researchers see the potential for STI-571 to slow the progression of CML, or perhaps even halt it. The drug may also make it possible for more CML patients to qualify for bone marrow transplants, often the only cure for CML. Due to the need for matching donors, however, even that option isn’t readily available to most CML patients. About 5,000 persons are diagnosed with CML each year in the United States.

Patients interested in more information or in participating in the clinical trial should call 1-800-492-5538 or visit http://www.umm.edu/cancer/therapies/clin_data.html.

Source: University of Maryland

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