Med School News
U OF L-DEVELOPED CANCER DRUG SHOWING PROMISE IN CLINICAL TRIAL
Ellen de Graffenreid
Sep 5, 2006

LOUISVILLE, Ky. * A second patient with late-stage renal cancer is responding well to a new drug discovered by University of Louisville researchers in a Phase I clinical trial being conducted at the James Graham Brown Cancer Center.

After being treated with a drug derived from guanine-rich oligonucleotides (GROs), a compound discovered by U of L faculty Paula Bates, Donald Miller and John Trent, the patient’s tumors have shrunk 70 percent, according to Damien Laber, principal investigator in the trial.

“Across the board, patients are responding well with fewer side effects than other available treatments. This particular patient’s results are very exciting, because the patient had relapsed after three prior therapies with common cancer drugs,” said Miller.

Miller, director of the James Graham Brown Cancer Center and associate vice president for health affairs at U of L, will present full data from the trial on Oct. 1 at the European Society of Medical Oncology annual conference in Istanbul, Turkey.

The clinical trial at the Brown Cancer Center includes 12 patients with renal cancer and five with lung cancer. The trial is sponsored by Antisoma, plc, which acquired Louisville-based Aptamera in October 2005. Aptamera was founded by Bates, Miller and Trent to bring GRO-based therapies to market.

GROs are short pieces of synthetic DNA that work by binding tightly to a specific protein present on the surface of cancer cells, interfering with tumor growth. Because the compounds select cancer cells over normal cells, GRO-based therapies have fewer side effects than many traditional cancer drugs.

“This is just one of many targeted drugs in the pipeline at the Brown Cancer Center and U of L, and we are doing everything we can to move these new therapies from the lab to the patients as swiftly as possible,” said Miller.

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NOTE TO REPORTERS: No additional patient information will be released, consistent with HIPAA regulations and the protocol for this clinical trial.

What is a clinical trial?
A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Clinical Trials are used to determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Clinical Trials are closely monitored and regulated by the U.S. GovernmentFour Phases of Clinical Trials
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

• Phase I - Researchers test a new drug or treatment in a small group of volunteers (20-80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects. When results from Phase I are promising (meaning the benefits appear to outweigh the risks), then Phase II Trials may begin.
• Phase II - The study drug or treatment is given to a larger group of volunteers (100 - 300) to see if it is effective and to further evaluate its safety.
• Phase III - The study drug or treatment is given to large groups of volunteers (1,000 - 3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
• Phase IV - Post marketing studies outline additional information including the drug's risks, benefits and optimal use.

About the James Graham Brown Cancer Center

The James Graham Brown Cancer Center is a key component of the University of Louisville Health Sciences Center, the region’s leading academic, research and teaching medical center. Patients treated at the Brown Cancer Center and all practices within UofL Health Care benefit from the latest medical advances, often long before they are available in non-teaching settings.

The Brown Cancer Center is affiliated with the National Cancer Institute and the Kentucky Cancer Program. It is the only cancer center in the region to use a patient-centered model of cancer care, with multidisciplinary teams of physicians working together to guide patients through diagnosis, treatment and recovery.