01/30/2009

FDA approves pilot study at WVU Cancer Center

New ointment could prevent hand-foot syndrome

MORGANTOWN, W.Va. – The U.S. Food and Drug Administration has approved a pilot study at West Virginia University to test an ointment developed by a team of cancer researchers to prevent hand-foot syndrome in patients who receive one of the most widely used cancer-fighting drugs in the world. 

Capecitabine, marketed as Xeloda, is an effective treatment for advanced breast cancer and cancers of the gastrointestinal tract.  However, more than half the patients who receive the chemotherapy drug develop a condition known as hand-foot syndrome, or pain, numbness, tingling, reddening or swelling in the hands or feet.  Peeling, blistering or sores on the skin in these areas are also possible.

The new ointment will be tested in patients participating in a clinical trial under way at WVU’s Mary Babb Randolph Cancer Center.

“Hand-foot syndrome can be very debilitating.  There is nothing available to treat or prevent the condition, other than reducing the dose of the anti-cancer drug, which may lessen its effectiveness,” said William Petros, Pharm.D., associate director for Anti-Cancer Drug Development and professor in the WVU School of Pharmacy, who initiated the ointment study.  “Our goal as researchers is to figure out a way around the toxicity without limiting the drug’s effectiveness.”

Working in conjunction with Adherex Technologies Inc., a biopharmaceutical research company, Petros directed a series of preclinical studies on the new ointment. WVU researchers made the ointment from an investigational drug called Eniluracil that Adherex has been developing as an oral drug for other uses.

“Our animal-based studies indicated that Eniluracil ointment applied topically to the skin could be effective in blocking enzymes we believe are involved in hand-foot syndrome caused by capecitabine,” he said. “This is an exciting area of research. If the ointment study proves successful it will be a major step toward alleviating toxic effects of the anti-cancer drug and optimizing its effectiveness.”
 
For information on clinical trials at WVU’s Mary Babb Randolph Cancer Center see http://www.hsc.wvu.edu/mbrcc/ctru/currentTrials/.

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For more information:
Amy Johns, HSC News Service, 304-293-7087
johnsa@wvuh.com
ss: 12-15-08

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