Drug development company Can-Fite BioPharma Ltd. (TASE:CFBI) says that its clinical advisory board has recommended that it conduct a further confirmatory Phase IIb trial for its CF101 drug for the treatment of rheumatoid arthritis, after the results of the last trial proved inconclusive. The company hopes to begin the trial in the first quarter of 2008 and complete it within a year, although it is still awaiting US Food and Drug Administration (FDA) approval for the trial protocol.
In July, Can-Fite published the results of its Phase IIb trial for use of the drug in treating rheumatoid arthritis, which it described as satisfactory. However, it was criticized because it did not manage to demonstrate the drug's efficacy according to the company's own primary index. The drug produced an improvement in rheumatoid arthritis patients, but a similar improvement was also seen in the control group using a placebo drug. Can-Fite made a highly unusual statement in which it said believed the placebo itself had a positive effect on the condition, which masked the effect of its drug, and named a substance which served as the solvent in both the placebo and the real drug, as the factor responsible for the improvement.
The cost of this trial could run into tens of millions of shekels, and the company will also need funds for its other clinical and preclinical trials. The company had NIS 44.6 million in cash at the end of June, so it may need to raise further finance in order to complete the trial. It recently received a further $500,000 from Japan's company Seikagaku Corporation (TSE: 4548) for meeting milestones set out in the contract between the two companies.
Published by Globes [online], Israel business news - www.globes.co.il - on October 24, 2007
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