From: Reuters
Published May 19, 2008 06:38 PM

Nexavar helped in pulmonary hypertension study

By Julie Steenhuysen

CHICAGO (Reuters) - The cancer drug Nexavar is showed promise in a small study of people with pulmonary hypertension, a debilitating condition marked by high blood pressure in the arteries that supply the lungs, U.S. researchers said on Monday.

Made by Bayer AG and Onyx Pharmaceuticals Inc, Nexavar is approved in the United States for kidney and liver cancer.

Eight out of the first nine patients who took the drug saw improvements in their ability to exercise, and six out of nine had significant improvement in their right ventricular ejection fraction, which measures the heart's ability to pump blood to the lungs.

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Four patients had decreased pressure in their pulmonary artery, which supplies blood to the lungs.

"What patients are telling us is they are able to do more in their daily lives," said Dr. Mardi Gomberg-Maitland of the University of Chicago, who presented her findings at a meeting of the American Thoracic Society in Toronto. The original research on the drug was done at the University.

She said the surprising thing is that the drug worked so quickly. Patients saw benefits in only four months.

The study is the first human trial to examine the sorafenib, or Nexavar, in pulmonary hypertension, a disease in which blood vessels feeding the lungs narrow, forcing the heart to work harder.

ABNORMAL CELL GROWTH

Like cancer, pulmonary hypertension is a disease marked by abnormal cell growth, which narrows the arteries feeding the lungs, reducing blood flow and taxing the heart. Sorafenib appears to interfere with this process.

The trial enrolled patients with stable disease who continued to take their primary medications, which included a continuous infusion of a drug called prostacyclin and Pfizer Inc's Viagra or sildenafil. Both relax blood vessels that feed the lungs.

Gomberg-Maitland said this therapy typically slows progression of the disease, but does not reverse it.

They added sorafenib for 16 weeks, but at a lower dose than cancer patients use.

Most patients in the trial increased their exercise capacity, as measured by time on a treadmill or a six-minute walk test. They saw an average 8 percent improvement in their right ventricular ejection fraction, a measure of the heart's pumping power.

Side effects included mild hair loss and skin reactions.

The study was designed to last only 16 weeks, but all of the patients continue to take the drug, some now for more than a year.

"What is exciting about this is all of the patients feel better and nobody wants to come off the medication," Gomberg-Maitland said in a telephone interview.

The study was intended to test the safety and dosing of the drug. It was funded by The Doris Duke Foundation and the University of Chicago.

The researchers now plan to study the drug in 40 to 60 patients at different research centers.

(Editing by Will Dunham; and Carol Bishopric)

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