Gongwin Biopharm Holdings Co Ltd (共信生醫) yesterday said that it has obtained the Taiwan Food and Drug Administration’s approval for a domestic phase II clinical trial for PTS100, its new liver cancer treatment.
The trial is expected to begin next month and be completed in 2019, the company said, adding that it is working with the National Taiwan University Hospital to enlist 30 liver cancer patients for the trial.
The study will focus on patients who have not responded to conventional first-line transarterial chemoembolization and who do not meet the criteria for other targeted therapy options, the company said.
PTS-100 is expected to fill a gap in treatment options for patients whose liver cancer has reached mid-to-advanced stages in combination with other treatments and surgeries, the company added
As liver cancer does not have discernible symptoms before the advanced stage, many liver cancer patients do not begin embolization therapy early enough, which leads to lower survival rates.
Based on p-toluenesulfonic acid, the company’s proprietary small molecule cancer drug, PTS-100, is a mini-invasive targeted chemo-ablation therapy injected directly into tumors to induce the breakdown of cancerous cells, the firm said.
Animal trials using ablation of PTS-100 have shown that it outperformed ethanol injection in terms of reducing tumor size by 59 percent, as well as leading to three times the amount of tumor cell necrosis, the company said.
It said that its ablation injections have milder side effects compared with conventional chemotherapy.
Meanwhile, a phase III clinical trial of PTS-302, the company’s lung cancer treatment, conducted in China has been completed and is awaiting approval for commercialization, it said.
The company is listed on the Taipei Exchange’s Emerging Stock Board.
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