NasVax Ltd. (TASE: NSVX) today announced success in the Phase IIa clinical trial of its oral anti-CD3 antibody for the treatment of hepatitis C, a chronic disease caused by the hepatitis C virus which disrupts the functioning of the immune system.
Following the announcement, NasVax's share price rose 25.1% to NIS 0.24, giving the company a market cap of NIS 11 million.
The trial included hepatitis C patients who had failed to respond to previous interferon treatments, the standard treatment for the disease. 36 patients aged 18-65 were divided into four groups of nine patients each. Three groups received different dosages of the anti CD3 antibody (0.2 mg, 1 mg, and 5 mg) orally over 30 days, and were monitored for an additional 30 days, for a total period of 60 days. The fourth group received a placebo.
The trial primary endpoints were to test the drug's safety profile and changes in immunological measures of the immune system, which are indications of the antibody's action. The secondary endpoint was to test markers indicating the clinical effectiveness of the treatment.
Analysis of the results was positive for all three endpoints.
The trial was carried out at two medical centers, the military hospital at Bydgoszcz in Poland and the Vienna General Hospital in Austria.
The trial's positive results follow the successful clinical trial of anti CD3 antibody for the treatment of non-alcoholic steatohepatitis (NASH), or fatty liver disease.
According to the World Health Organization, 170 million people worldwide suffer from hepatitis C, with 3-4 million new cases occurring annually. There are an estimated 3 million cases of chronic hepatitis C in the US and 5-10 million cases in Europe. The market for treatments is expected to rise from $4 billion in 2009 to $8.;5 billion in 2016.
Published by Globes [online], Israel business news - www.globes-online.com - on October 2, 2012
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