PTS100
Indication
Primary liver cancer such as hepatocellular carcinoma (HCC).
Current Status
1. Phase II clinical trial in Taiwan (in NTUH, TMUH, and Taipei VGH) is ongoing.
2. Application to the Ministry of Health and Services for 3 new partner hospitals (Taichung VGH, LCGMH, and KVGH) in Q4 2024.
Product Advantages
1. Innovation: PTS100 provides a new treatment method for intermediate and advanced liver cancer. After locating the tumor by ultrasound, the drug is injected directly into the tumor via subcutaneous puncture, which has been clinically proven to be effective in controlling intermediate and advanced liver cancer patients.
2. Safety: Minimally invasive treatment by percutaneous transluminal puncture paired with PTS-specific pharmacological mechanisms and limited side effects.
3. Efficacy: Gongwin Biopharm Co., Ltd. has completed a phase II clinical trial in China, in which PTS was administered by skin puncture to patients with advanced liver cancer (primary or metastatic liver cancer, patients who are not suitable for surgery, or patients who still have tumor after atheroembolization). 83 patients were enrolled in the trial.
At 4 weeks after treatment, according to the Response Evaluation Criteria in Solid Tumors (RECIST), the DCR (Disease Control Rate) of the patients was as high as 72%, and the tumors had shrunk.
Market Potentials
1. According to the Market Data Forecast report [1], the global liver cancer therapeutics market size is forecasted to grow to USD 1366.96 million by 2029 from USD 884.36 million in 2024, registering a CAGR of 9.1% during the forecast period.
2. According to the WHO [2], liver cancer still ranks among the top five cancers in the world in terms of incidence and mortality, with more than 70% of them occurring in Asia, with nearly 610,000 new cases and 560,000 deaths each year, of which nearly half of the patients are in China.
3. According to statistics from the Ministry of Health and Welfare [3], liver cancer is the second leading cause of cancer deaths in Taiwan (second only to lung cancer), with 11,225 liver cancer cases in 2017.
Additional Point - About PTS100 and HCC
According to the Barcelona Clinic Liver Cancer staging system, there are three stages: early, intermediate and advanced. Staging is based on the size and number of tumors.
1. Early stage: Small tumors up to and including three tumors.
2. Intermediate stage: multiple tumors or large tumors
3. Advanced stage: metastasis or hepatic vascularization
Treatment Options Section:
1. Early stage (about 30%) The first choice of treatment for liver cancer patients includes radical treatment such as surgery, liver transplantation and ablation.
2. Intermediate stage (about 20%) The standard of care for liver cancer patients is localized treatment such as Transcatheter arterial chemoembolization (TACE), while other treatment options include embolization radiotherapy and arterial infusion chemotherapy.
3. Patients with advanced liver cancer (about 50%) are mainly treated with systemic therapies such as targeted chemotherapy or supportive therapies.
Since the liver does not have nerves but only the peripheral membrane, the symptoms of cancer are not obvious in the early stage, and more than half of the patients are already in the incurable intermediate and advanced stage when they are diagnosed, with a median survival period of about 9~12 months.
For mid-stage liver cancer, many patients who cannot be treated with standard TACE or who have failed TACE treatment often have advanced disease within one year because there are no other recommended treatments before the disease has progressed to advanced stage. Therefore, there is a need for effective and safe treatments to slow down the progression of intermediate liver cancer, and PTS products may provide a new treatment option at this stage.
References