FDA approves Exalenz liver cancer trial

The trial will include 100 patients at five medical centers - three in the US and one each in Canada and Israel.

Exalenz Bioscience Ltd. (TASE:EXEN) has received US Food and Drug Administration (FDA) approval for a clinical trial of the company's non-invasive BreathID device for the early diagnosis of Hepatocellular Carcinoma, a liver cancer.

The trial will include 100 patients at five medical centers - three in the US and one each in Canada and Israel (at Hadassah Medical Organization in Jerusalem) - to test the effectiveness of the BreathID device for the early detection of liver cancer. Exalenz will begin the trial during the fourth quarter of the year.

In July, Exalenz reported positive results in the preliminary trial of the BreathID device to diagnose liver cancer. In that trial at Hadassah, the device achieved 93% congruence with diagnosis by CT or MRI tests.

Exalenz said that, assuming that the clinical trial is a success, and the company has the financial resources to implement marketing, it intends to offer the BreathID as a more accurate and reliable means for diagnosing liver cancer than current screening by ultrasound, followed by CT or MRI tests.

Hepatocellular Carcinoma is the sixth most prevalent form of cancer in the world, and the third most lethal. The number of new cases is steadily increasing, and it currently kills 700,000 people a year.

Exalenz said that Asia is a potential market, because it has a very high incidence of liver cancer and 10% of the population is at risk, due to the prevalence of type B hepatitis and Cirrhosis of the liver, giving a market worth hundreds of millions of dollars. The company and Easton Associates have also conducted a market survey in the US, which found a need for the BreathID device for this indication.

Exalenz's share price rose 2.8% by mid-afternoon to NIS 0.728, giving a market cap of NIS 95 million

Published by Globes [online], Israel business news - www.globes-online.com - on September 8, 2011

© Copyright of Globes Publisher Itonut (1983) Ltd. 2011

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