Frank Giles, M.D., M.B., a professor of medicine in hematology and medical oncology at the CTRC, is one of the foremost researchers in developing new drugs to battle chronic myeloid leukemia.
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Contact: Karen Stamm, 210-450-2020

With Kareem Abdul-Jabbar’s announcement that he is undergoing treatment for a rare cancer known as chronic myeloid leukemia (CML), national attention is being focused on new, life-saving treatments that bring hope to those who are battling this cancer of the blood and bone marrow.

One of the foremost researchers in developing these new drugs is Frank Giles, M.D., M.B., a professor of medicine in hematology and medical oncology at the Cancer Therapy & Research Center (CTRC) of the UT Health Science Center. He says new results reported in October for the drug nilotinib (sold as Tasigna) “represent a very significant step toward cure” for CML. Dr. Giles has been one of the leading scientists involved in developing nilotinib from its earliest stages.

“Had Kareem Abdul-Jabbar been diagnosed with chronic myeloid leukemia 40 years ago, his chance of survival would have been close to zero,” Dr. Giles said. “Today the survival rate is over 95 percent. That improvement is attributable to imatinib.”

Imatinib a 'wonder drug' for most patients
When it was released in 1998, imatinib (sold in the U.S. as Gleevec) was considered a wonder drug, he said. “Gleevec showed that if you can identify a critical kinase or enzyme of target, you can develop therapy that affects only the cancer and leaves normal cells largely alone,” he said.

Nilotinib developed for those resistent to imatinib
The problem was that while patients treated with Gleevec had a 95 percent survival rate after five years, about 15 percent of them became resistant to the drug or intolerant of it. Dr. Giles and his team created nilotinib as a second-line therapy for patients who no longer benefited from Gleevec. The team took the drug from the laboratory through approval by the Food and Drug Administration in October 2007.

Large international study now comparing the two treatments
Novartis, the company that manufactures both Gleevec and Tasigna, was eager to learn if nilotinib might work better than Gleevec as a frontline therapy. It developed a large global randomized trial comparing the two drugs. On Oct. 20, 2009, Novartis announced that Tasigna produced “faster and deeper” responses than Gleevec, and that patients tolerated the drug well.

Ronan Swords, M.D., assistant professor of medicine at the CTRC, is investigating whether nilotinib used as a frontline treatment will be as effective at a lower dose.

Preliminary results from a clinical trial in Ireland at College Hospital Galway (in partnership with Dr. Giles) show a significant decrease in the level of abnormal cancer-induced protein in the blood of patients taking the drug after just three months.

Dr. Swords evaluating nilotinib dosages
While the CTRC does not have patients in that global trial, CTRC patients are taking nilotinib in another international study, led locally by Ronan Swords, M.D., assistant professor of medicine. This project is evaluating whether nilotinib used as a frontline treatment will be as effective at a lower dose, 300 mg rather than 400 mg twice a day, the dose studied most recently.

Nolotinib appears to be promising for all CML patients
“Nilotinib appears to be the next step in curing CML,” Dr. Swords said. “The chances of patients developing resistance to nilotinib are reduced significantly because patients respond more dramatically and more quickly than those taking imatinib. The sooner the disease goes into remission, the better our chance for a cure.”

About 5,000 people are expected to be diagnosed in 2009 in the United States with CML, one of four main types of leukemia, according to the Leukemia and Lymphoma Society. Symptoms tend to develop gradually and include tiring more easily, shortness of breath doing usual activities, pale skin color, enlarged spleen leading to a "dragging" feeling on the upper left side of the abdomen, night sweats, an inability to tolerate warm temperatures and weight loss. The society cautions that most of these signs and symptoms are common to other illnesses, and that most people who have them do not have CML.

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The Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio is one of the nation's leading academic research and treatment centers, serving more than 4.4 million people in the high-growth corridor of Central and South Texas including Austin, San Antonio, Laredo and the Rio Grande Valley. CTRC is one of the elite cancer centers in the country to be named a National Cancer Institute-designated Cancer Center, and is one of the only three in Texas. A world leader in developing new drugs to treat cancer, the CTRC Institute for Drug Development is internationally recognized for conducting one of the largest oncology Phase I clinical drug programs in the world, and participates in the clinical and/or preclinical development of many of the cancer drugs approved by the U.S. Food & Drug Administration. For more information, visit www.ctrc.net