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2019-11-21 Gongwin-KY’s Liver Cancer New Drug PTS100 Joins forces with Three Major Hospitals Sprinting at Phase II Human Clinical Trials

Taipei,November 21, 2019

Gongwin Biopharm Holdings Co., Ltd. (hereinafter referred to as "Gongwin-KY", stock code: 6617) in Taipei formally received an official letter from the Ministry of Health and Welfare today, regarding its primary liver cancer new drug PTS100 and phase II human clinical trial jointly conducted by the National Taiwan University Hospital, Taipei Veterans General Hospital, and Taipei Medical University Hospital; the Ministry of Health and Welfare granted approval for this trial to remove low-dose group. In the original design of clinical trial, two different doses of PTS100, high and low, were proposed, aiming to compare the benefit/risk ratio in the two dose groups through clinical information of the dose response. However, after performing local injections of PTS100 for many patients in this trial and observing the dose responses, it was determined to remove the low-dose group based on the doses used in the past clinical trials to accelerate the progress of phase II clinical trials.

Gongwin-KY pointed out that the clinical trial targeted on liver cancer patients who failed arterial embolization treatment and yet did not meet the targeted drug treatment criteria, the original target was expected to be about 30 patients. After the low-dose group was removed, the number of cases accepted was estimated to be about 15 people. It is expected that the clinical case acceptance and the first-year follow-up of subjects will be completed by the end of 2020, and then Phase III clinical trial application will be submitted to TFDA.

Gongwin-KY stated that, according to the previous phase IIb clinical trial of liver cancer with new drug PTS100 previously approved by China’s CFDA, after four weeks’ follow-up observations of 75 advanced liver cancer patients who received PTS100 injection treatment, as high as 60% of the subjects’ tumors had areas of necrosis exceeding 50%; and in terms of the treatment effect, as many as 72% of the subjects’ tumors did not continued to deteriorate. The good result from the effectiveness analysis of advanced liver cancer is precisely one of the key factors for which PTS100 could successfully be granted TFDA approval, receive support from three major hospitals, and perform phase II human clinical trials in Taiwan.

As show in the data recently released by the International Agency for Research on Cancer (IARC) under the World Health Organization, in 2012 there were 782,000 new liver cancer patients worldwide; among them, the number of new liver cancer patients in Asia was as high as 590,000, accounting for 75.4% of liver cancer patients globally. It is sufficient to say that emerging Asian countries are prone to liver cancer. In addition, according to the cause of death statistics by Ministry of Health and Welfare, not only are there more than 11,000 people diagnosed with liver cancer annually in Taiwan, but also more than 8,000 patients died of liver cancer annually, and the mortality rate remains high.

As early stage of liver cancer shows no signs of symptoms, it is usually already in the middle and late stages from the onset of symptoms to the time of diagnosis. For liver cancer patients with multiple tumors (>3) or large tumors (>5 cm), the general standard treatment is arterial embolization, but embolization treatment is generally ineffective and the probability of failure is high. Phase II clinical trial conducted by Gongwin-KY in cooperation with three hospitals was through image-guided percutaneous injection of PTS100 into liver tumors to directly destroy cancer cells. This is considered a method of "Mini-invasive targeted Chemo-Ablation Therapy" expected to target liver cancer patients whose current hepatic artery embolization (TAE) failed and not yet meet the treatment criteria for targeted drugs, fulfilling the needs at prime time for treatment before diseases worsen as well as allowing PTS100 attract the attention and expectations from the medical market.

Looking forward to the future, Gongwin-KY expects to combine PTS100 with other topical treatment methods. The direction of clinical trials can not only verify that the combined treatment of PTS100 and hepatic artery embolization (TAE) is an effective treatment, but can also target small liver tumors below 3 cm by observing whether the combined treatment of PTS100 and Radiofrequency Ablation Therapy (RFA) is in fact an effective treatment method, in order to bring brand-new treatment opportunities for liver cancer patients.