On the 25th, Gongwin Biopharm Holdings Co., Ltd. announced that its PTS new drug retrospective study plan has been approved by Taipei Veterans General Hospital, with an expected completion of the report in the third quarter of this year. The study report will serve as one of the supportive data for the multi-national, multi-center MPE clinical trials scheduled to begin in the fourth quarter of this year, significantly aiding in the planning of the trial.
Gongwin Biopharm Holdings stated that the new drug retrospective study plan is a research design aimed at evaluating the effectiveness, safety, usage patterns, and patient outcomes of new drugs through the analysis of existing medical records or database data. The retrospective study applied for this time will analyze the efficacy data of 15 patients treated with PTS therapy at Taipei Veterans General Hospital between 2022 and 2023. The preliminary data compilation for the study is planned to be completed by the end of April, followed by approximately two months of statistical analysis, with results expected to be announced in the third quarter of this year.
Mr. Lin Mao-yuan, General Manager of Gongwin Biopharm Holdings , stated that MPE is a major complication associated with various types of cancer, leading to reduced quality of life and poor prognosis for affected patients. The results of this study will provide valuable data on the safety and efficacy of PTS therapy for treating MPE and serve as supportive data for this year's planned multi-national, multi-center MPE clinical trials.
Gongwin Biopharm Holdings also plans to commence phase two/three clinical studies for MPE in Taiwan and Australia simultaneously in the fourth quarter of this year. This research plan will be submitted to the Taiwan Food and Drug Administration (TFDA) by the end of this year. The experimental design will be divided into two stages, with the initial enrollment of 40 subjects in Taiwan, followed by a midterm analysis. This phase is expected to take three to four months. Based on the analysis results, adjustments will be made to the research strategy for the second stage, and trial centers will be initiated in Australia to enroll subjects synchronously with Taiwan.
Gongwin Biopharm Holdings already has multiple products on the market, such as Purocenta and Aifenning, while actively developing multiple projects including PTS100 primary liver cancer, PTS-02 adenoid cystic carcinoma, PTS500 malignant pleural effusion, and GWA101 drugs for canine and equine tumors.
Gongwin Biopharm Holdings stated that based on current clinical results, through combined application with traditional minimally invasive surgery, PTS can not only reduce the scope of organ resection and the risk of recurrence but also improve treatment effectiveness, enhance patient quality of life, and prolong survival. Compared to current treatment methods, PTS demonstrates its unique therapeutic advantages.
Resource:
為多國多中心MPE臨床試驗暖身 共信-KY 宣布開啟 PTS 新藥回顧性研究
