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Polaris lung cancer clinical trial phase III analysis reached the highest standard, and drug certification is imminent

The Phase III interim analysis of the Polaris-KY (6550TW) clinical trial in the U.S. for lung mesothelial cancer (a type of lung cancer) was released on February 25, 2012. Based on current interim data, the overall success rate for the final trial is estimated to be above 80% (80-100%). The experts explained that this means that the ADI PEG-20 treatment group will have a statistically significant chance of exceeding the overall survival of the control group by more than 80% after continued enrollment in the Phase III trial.

This will be strong evidence of ADI efficacy and is necessary to obtain drug certification. This clinical trial is a multi-country, multi-center, phase II/III trial of Polaris’ new drug ADI-PEG 20 in combination (Pemetrexed + Cisplatin) for the treatment of lung mesothelial cancer. The Phase II trial enrolled 176 patients, and the Phase II and Phase III trials enrolled 386 patients. 232 patients were enrolled by the end of February and were analyzed by an independent expert panel on the 25th. Polaris said that the progress of patient enrollment in the past year was significantly slowed by the epidemic, and now, encouraged by the results of the interim analysis, we will do our best to accelerate patient enrollment in the future as the epidemic gradually subsides, in the hope of obtaining the drug certificate as soon as possible.

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