Gongwin-KY (6617) announced that it would collaborate with NTU Hospital to initiate phase II human clinical trial of primary liver cancer new drug PTS100. The research program targets liver cancer patients who either have failed standard embolization therapy (TACE) or have not yet met the criteria for targeted drug treatment. It is expected that 30 cases would be accepted, and the patient acceptance is expected to complete by the end of 2019 the earliest.
Yang Quan-Qing, the Deputy General Manager of Gongwin’s R&D department, pointed out that, according to the phase IIb clinical trial of liver cancer new drug PTS100 approved by China’s CFDA, out of 75 advanced liver cancer patients who received PTS100 injection treatment, after four weeks of follow-up observation, a total of as high as 60% of the subjects showing over 50% of tumor necrosis area; and in terms of the treatment effect assessment, as high as 72% of the subjects’ tumors did not continue to deteriorate, indicating good result of advanced liver cancer effectiveness analysis.
According to the recent data released by the International Agency for Research on Cancer (IARC) under the World Health Organization, there were782,000 new liver cancer patients globally in 2012, of which as many as 590,000 were in Asia, accounting for 75.4% of global liver cancer patients. It is evident that people in emerging countries in Asia are susceptible to liver cancer. In addition, according to the statistics of the cause of death from the Ministry of Health and Welfare, there are not only more than 11,000 people diagnosed with liver cancer per year, but also over 8,000 patients die of liver cancer per year. The mortality rate remains high.
Yang Quan-Qing emphasized that, as liver cancer shows no symptoms in its early stage, it is usually already in the mid and advanced stages from the onset of symptoms to the time when it is diagnosed. For liver cancer patients with multiple tumors (>3) or large tumors (>5 cm), the general standard treatment is arterial embolism. However, the embolization treatment is generally ineffective and the probability of failure tends to be high; the phase II clinical trial which is jointly conducted by Gongwin and National Taiwan University Hospital is to inject PTS100 percutaneously into liver tumors through imaging guidance to directly destroy cancer cells. This "Mini-invasive targeted Chemo-Ablation Therapy" is expected to target liver cancer patients whose current arterial embolization therapy has failed the and those have not yet met the criteria to receive targeted drug treatment, fulfilling the golden period of treatment before the disease worsens.
Looking forward to the future, Gongwin-KY hopes to combine PTS100 with other local treatment methods. The clinical research direction not only can verify that the combined treatment of PTS100 and TACE is an effective treatment method, it can also be used to observe whether the combined treatment of PTS100 and radiofrequency ablation (RFA) would be an effective treatment method for small liver tumors below 3 cm, aiming to bring new treatment opportunities for liver cancer patients.
In addition, Gongwin-KY’s lung cancer new drug PTS302 has officially entered the technical review and approval stage for Mainland China's drug certification. It is expected that the China drug certificate will be approved the earliest this year. There are also plans to submit phase II clinical trial applications of PTS-02 for adenoid cystic carcinoma and PTS500 for malignant pleural effusion in the US and Australia markets to create a complete global PTS anti-cancer drug deployment.
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