Contact: Will Sansom
Phone: (210) 567-2579

Thanks to Dr. Frank Giles and his team, patients with a life-threatening form of leukemia have hope with a new oral drug, nilotinib.
Printer Friendly Format

SAN ANTONIO — The 2007 recruitment of one of the world’s leading drug development experts, Frank J. Giles, M.D., to The University of Texas Health Science Center at San Antonio and the Cancer Therapy & Research Center (CTRC) has pole-vaulted the city to a preeminent position in the conception, design, study and approval of novel anti-cancer drugs.

World-class drug discovery program
“San Antonio now has one of the largest drug discovery programs in the world,” said Tyler J. Curiel, M.D., M.P.H, professor and director of the San Antonio Cancer Institute (S.A.C.I.). S.A.C.I. is a partnership between the Health Science Center and CTRC, and is one of the three National Cancer Institute-designated Cancer Centers in Texas.

South Texans benefit from local drug research
San Antonio is “one of the few sites on earth” that has such a large multidisciplinary team able to create a new agent, conduct preclinical and animal studies, modify it if necessary, and move it to clinical research trials in humans, Dr. Curiel said. Patients in San Antonio and South Texas are benefiting by having access to these agents more quickly than could be done by any other group.

Newest drug approved Oct. 29 for CML, a type of leukemia
The city’s new prominence in drug development was in full view Oct. 29 when the U.S. Food and Drug Administration (FDA) granted fast-track approval to nilotinib, a therapy developed from start to finish by Dr. Giles and his team. In clinical research trials, nilotinib effectively treated patients suffering from Philadelphia chromosome-positive chronic myelogenous leukemia (CML). These patients had become resistant to or were unable to tolerate imatinib, the frontline therapy for this type of blood cancer, which affects 4,500 people in the U.S. annually.

Nilotinib, administered orally, is marketed by Novartis under the brand name Tasigna®. “Dr. Giles took this drug from a gleam in Novartis’ eye and helped make it an approved drug here and in Europe,” Dr. Curiel said. “This is one of several important drugs that he has guided to approval. Now he and his colleagues are conducting trials here at the Cancer Therapy & Research Center and the San Antonio Cancer Institute that will lead to additional great drug approvals such as this one.”

“We are increasingly known for our ability to focus on exquisitely targeted cancer therapies,” said Dr. Giles, who came to San Antonio from The University of Texas M.D. Anderson Cancer Center in Houston. He is professor and chief of the Division of Hematology and Medical Oncology at the Health Science Center, director of the experimental therapeutics program at S.A.C.I. and director of CTRC’s Institute for Drug Development.

Trials show drug led to 70 to 80 percent remission rate in chronic CML patients
Nilotinib was synthesized about five years ago. “This is one of the shortest times such an agent has been moved from concept to FDA accelerated approval,” Dr. Giles said.
CML generally follows a three- to five-year course, including a chronic phase, an advanced phase and an end-stage phase. Nilotinib treatment led to remissions in 70 percent to 80 percent of patients in the chronic phase who had failed the current frontline treatment, Dr. Giles said. Responses are measured by elimination of all traces of leukemia from the blood and by cancer-curbing chromosome changes.

More cancer drugs promised for the future
The medical community can expect more from the San Antonio drug development team in the future. “We have delivered,” Dr. Giles said. “More than just saying we could do it, we have done it, and what we have done once, we are going to do again and again. We are learning to do it better and faster, and that is going to apply to traditional cancer drugs, targeted drugs, immune modulation, cancer vaccines and the use of viruses as anti-cancer agents.” For CML patients, the new therapy is nothing short of lifesaving. “The scale of our belief that we can cure people with this leukemia has improved dramatically the last five years,” Dr. Giles said.

###
The University of Texas Health Science Center at San Antonio is the leading research institution in South Texas and one of the major health sciences universities in the world. With an operating budget of $576 million, the Health Science Center is the chief catalyst for the $15.3 billion biosciences and health care sector in San Antonio’s economy. The Health Science Center has had an estimated $35 billion impact on the region since inception and has expanded to six campuses in San Antonio, Laredo, Harlingen and Edinburg. More than 22,000 graduates (physicians, dentists, nurses, scientists and allied health professionals) serve in their fields, including many in Texas. Health Science Center faculty are international leaders in cancer, cardiovascular disease, diabetes, aging, stroke prevention, kidney disease, orthopaedics, research imaging, transplant surgery, psychiatry and clinical neurosciences, pain management, genetics, nursing, allied health, dentistry and many other fields.