PTS500
Indication
Malignant pleural effusion (MPE).
Current Status
Phase II clinical trial IND application ongoing in Taiwan.
In the future, Gongwin will initiate multi-center clinical II/III trials in multiple countries (in Taiwan and the United States).
Product Advantages
Safety and Efficacy: PTS500 has a competitive advantage over existing treatments in the treatment of MPE, as it selectively kills cancer cells, prolongs the time to recurrence, and reduces patient discomfort.
Preliminary Results of The Retrospective Study
In MPE cases, it is known that patients have a high incidence of mild to moderate dizziness side effects after the first 5 ml dose, which resolves or recovers within 4-5 hours.
The current 4-week MPE control rate is 75.0% and the mPFS is 60 days. (PFS is defined as the number of days after CXR or outpatient evaluation without re-accumulation of pleural fluid).
The change of cancer cells in the pleural fluid disappeared after two doses of PTS, which is not possible with all sclerosants, and indicates the potential of PTS in treating MPE.
Market Potentials
Nearly 18 million patients are diagnosed with cancer each year, and malignant costochondral effusion is associated with a 15-20% chance of developing malignant costochondral effusion in all cancer cases, with the number of patients with malignant costochondral effusion estimated at 2.7 million patients worldwide.
MPE occurs in only 15% of patients in the early stages of lung cancer and in about 50% of patients in the middle to late stages of the disease. High prevalence of lung and breast cancers are the most common causes of MPE, accounting for 50-65% of cases [1].
Learn More About PTS500 and MPE
The lungs and chest cavity are surrounded by the costal membrane. The space between the lungs and the chest wall is called the costal cavity. Normally, the two layers are close together, with only a small amount of fluid (about 5–15 cc) between them to lubricate the lungs as they expand and contract during normal breathing.
When there is more fluid than normal in the chest cavity, the lungs are compressed, and this is called a costal effusion. This very small amount of pleural fluid can increase in certain diseases. It is usually an exudate when there is a change in pressure due to a systemic disease, or an exudate when there is localized inflammation of the lungs due to a chest disease (such as pneumonia or malignant tumors). If cancerous cells are present in the fluid, it is called malignant pleural effusion (MPE).
MPE is a condition in which fluid accumulates abnormally in the space between the chest wall and lungs when a malignant tumor has metastasized. Depending on the severity of the disease, large amounts of fluid can compress the lungs, causing breathing problems, coughing and chest pain, which can have a serious impact on your quality of life.
The clinical symptoms of MPE can be very variable, and sometimes the patient may not feel anything at all. The following are common symptoms of MPE:
- Shortness of breath (at rest or during activity)
- Chest pain or a feeling of pressure in the chest
- Coughing
- Pain when taking deep breaths or inability to take deep breaths
- Fever
- Fatigue
Once a patient is diagnosed with MPE, survival is usually between 3 and 12 months, depending on the type of primary cancer [1]. According to the staging definition of lung cancer, once a lung cancer patient develops MPE, it is considered stage IV lung cancer.
Since existing therapies have limited improvement in the survival of patients with MPE, the goal of treatment is to relieve respiratory symptoms and maintain the quality of life at the end of the cancer. Currently, pleural immobilization, either chemically (talc or other drugs) or physically (indwelling drains), is commonly used to prevent MPE from compressing the thoracic cavity by reducing the amount of MPE that can be accumulated, and to minimize respiratory symptoms in patients [2].
The use of talcum powder for pleural immobilization must be controlled in terms of powder size; otherwise, there is a risk of acute respiratory distress syndrome (ARDS), and pleural immobilization by physical repetitive drainage requires several weeks of treatment and therefore carries a risk of wound infection. Regardless of the method, pleural fixation causes adhesion between the lungs and the chest wall and does not eliminate the cancer cells in the chest, so safer and more effective treatments are still needed.
References