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By Kao Shih-ching / Staff reporter
Polaris Group (北極星藥業集團) yesterday said that phase 3 clinical trials for its mesothelioma treatment ADI-PEG 20 has been successful, adding that it plans to apply next year for marketing approval with the US Food and Drug Administration (FDA).
The trials showed that two main test gauges reached statistical significance, Polaris said, referring to overall survival (OS) — the time a patient survives from the beginning of treatment — and progression-free survival (PFS) time — the time a patient’s cancer does not worsen from the beginning of treatment.
The median OS time for the 125 participants treated with ADI-PEG 20 was 9.3 months, 21.4 percent higher than 7.66 months for the 124 participants in the control group, Polaris said.
The median PFS time was 6.11 months, compared with 5.59 months for the control group, it said.
The trials showed that 98.4 percent and 8.8 percent of all participants in the test group reported adverse events and serious adverse effects respectively, lower than 99.2 percent and 9.7 percent in the control group, it added.
“The small difference between the ratios of people with adverse effects in the two groups signifies the safety of ADI-PEG 20,” it said.
The trials were conducted in 38 hospitals in five countries: Taiwan, the US, the UK, Australia and Italy, it said.
As Polaris in February received the FDA’s fast-track designation, its application for marketing approval would be expedited, Polaris chairman Howard Chen (陳鴻文) told a news conference, adding that the company plans to submit the application at the beginning of next year.
Even though the number of people with mesothelioma is not high, totaling 38,000, the company is confident about the drug’s sales prospects, Chen said.
As Polaris developed ADI-PEG 20 with a metabolism-based strategy that depletes arginine, which causes stress and cytotoxicity in tumors, it could continue to try combining ADI-PEG 20 with other chemotherapy drugs for treating other kinds of cancer, the company said.
Polaris said that cumulative revenue in the first eight months of this year plunged 40 percent year-on-year to NT$5.55 million (US$176,527).
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