Arranon cancer drug receives advisory committee support

September 29, 2005

HOUSTON - Oncology patients received a small dosage of hope last week when Arranon® (nelarabine) Injection, a cancer-fighting drug, was recommended for accelerated approval by the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA). Arranon is targeted towards adult and pediatric patients fighting T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL), -- blood cancers that affect how the body makes blood and provides immunity from other diseases. The new drug, developed by GlaxoSmithKline (GSK), would be an option for patients whose disease has not responded to or has relapsed following at least two chemotherapy regimens.

Dr. Stacey Berg, co-director for Texas Children's Cancer Center clinical pharmacology group in Houston, led the Children's Oncology Group's (COG) phase 2 trial that played a major role in last week's recommendation for approval.

"The recommendation for accelerated approval is encouraging, particularly to pediatric oncologists," said Berg, who is an associate professor of pediatrics at Baylor College of Medicine. "There simply are not enough treatment options available for children with these particular cancers that often resist frontline therapy. If approved by the FDA, Arranon will give us the ability to offer more hope to our patients and their families."

In addition to the study in pediatric patients, a phase 2 study was conducted in adult patients by Cancer and Leukemia Group B (CALGB) in association with the Southwest Oncology Group (SWOG). Both of the adult and pediatric studies were sponsored by the Cancer Therapy Evaluation Program of the National Cancer Institute (NCI), under a Clinical Trials Agreement between NCI and GSK.

Pediatric cancer continues to be the second leading cause of death among children, behind accidental injury. Each school day, nine children die from the disease.

Texas Children's Cancer Center, located within Texas Children's Hospital in Houston, is the largest pediatric cancer and blood disorder program in the country. The Cancer Center sees patients from 34 states and 26 countries and sees nearly 25,000 annually in its outpatient clinic. All of its physicians are faculty members at Baylor College of Medicine.

For more information about Texas Children's Cancer Center, visit www.texaschildrenshospital.org. For more information about Baylor College of Medicine, visit www.bcm.edu.
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About Baylor College of Medicine
Baylor College of Medicine in Houston, the only private medical school in the Greater Southwest, was founded in 1900 and is today an internationally respected medical and research institution known for excellence in education, research and patient care at Baylor College of Medicine.

About Texas Children's Hospital
As one of the nation's largest pediatric hospitals, Texas Children's is renowned for its expertise and breakthrough development in the treatment of cancer, premature infants, cardiogenic disorders, diabetes, asthma, HIV/AIDS and attention-related disorders. Since opening its doors in 1954, the Texas Children's Hospital Integrated Delivery System (IDS) has cared for more than 1 million children from every corner of the world, and has more than 2 million patient encounters a year. Internationally recognized, the hospital is ranked in the top four among children's hospitals by both Child magazine and U.S. News and World Report.

Texas Children's Hospital

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