para-toluenesulfonamide (PTS100) / Gongwin Biopharm - LARVOL DELTA

A novel agent, p-toluenesulfonamide, in the management of malignant pleural effusions. (PubMed, Lung Cancer) - "Collectively, these results indicate that PTS effectively inhibits tumor growth, reduces MPE accumulation, and avoids pleural adhesion, highlighting its potential as a promising therapeutic option for managing MPE. Further comprehensive studies are warranted to establish its clinical role."

Journal • Pleural effusion • Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor

A novel agent, para-toluenesulfonamide, for the management of malignant pleural effusions. (ASCO 2025) - "PTS was demonstrated to be safe and effective when administered directly into the pleural cavity for MPE management. Intrapleural PTS administration shows potential in providing patients with MPE an alternative approach to chemotherapy or pleurodesis to alleviate their symptoms and more efficiently reduce their cancer burden. Further comprehensive studies are warranted to gain a better understanding of PTS in MPE treatment."

Pleural effusion • Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • CCL2

Gongxin joins hands with Mackay Hospital to conduct human clinical trial for oral cancer [Google translation] (stock.yahoo) - "Gongxin...announced on the 25th that after its new PTS cancer drug obtains Chinese drug license in 2023, in order to expand its indications, it will work with Mackay Hospital to conduct human clinical trials for oral squamous cell carcinoma...This clinical trial is 'p-toluenesulfonamide (PTS) combined with paclitaxel (Paclitaxel) therapy. It is a precision tumor treatment for patients with recurrent/unresectable/metastatic squamous oral cancer. The PTS drug is directly injected into the oral tumor through puncture , destroying cancer cells, is one of the new innovative treatments....Therefore, this trial of combining PTS with low-dose paclitaxel for oral cancer patients will avoid the discomfort caused by traditional chemotherapy drugs in the past, and at the same time highlight the tumor ablation characteristics of PTS, which will pave the way for future oral cancer treatment."

Commercial • New trial • Oral Cancer • Squamous Cell Carcinoma

Gongxin-KY subsidiary PTS100 liver cancer phase II clinical trial passed the review and approval of Kaohsiung Rongzong Subject Protection Advisory Committee [Google translation] (MoneyDJ) - "Gongxin Pharmaceutical Technology Co., Ltd...announced that the PTS100 liver cancer phase II clinical trial has been reviewed and approved by the Subject Protection Advisory Committee of Kaohsiung Veterans General Hospital...In order to accelerate the progress of the second phase clinical trial of PTS100 liver cancer in Taiwan, we applied for Kaohsiung Veterans General Hospital to be a new clinical trial base....A phase II, dose-randomized, open-label clinical trial to evaluate the safety and efficacy of PTS100 in patients with primary liver cancer (HCC) who are not suitable for surgical resection or existing locoregional treatments."

Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Gongxin-KY: Shin Kong Hospital’s executive subsidiary PTS100 is approved for the treatment of esophageal cancer patients as compassionate therapy [Google translation] (MoneyDJ) - "...Our company's subsidiary Gongxin Pharmaceutical Technology Co., Ltd...received a letter from Taiwan's Ministry of Health and Welfare, agreeing that Taiwan Gongxin will provide 'PTS100 (Para-Toluenesulfonamide, P- TSA) 330mg/mL, 5mL/amp' is for use by patients with esophageal cancer. This treatment is a compassionate therapy cooperating between our company and Shin Kong Medical Foundation Shinko Oh Hyoshi Memorial Hospital, and is treated by Shinko Medical Foundation Shinko Oh Hyoshi Memorial Hospital."

New trial • Esophageal Cancer • Oncology • Solid Tumor

Gongxin-KY: PTS100, an executive subsidiary of the National Taiwan University Medical College Hospital, is approved for the treatment of patients with adenoid cystic carcinoma. [Google translation] (LINE TODAY) - "Our company's subsidiary Gongxin Pharmaceutical Technology Co., Ltd...received a letter from the Ministry of Health and Welfare of Taiwan, agreeing that Taiwan Gongxin will provide 'PTS100 (Para-Toluenesulfonamide, P - TSA) 330mg/mL, 5mL/amp' is for use by patients with adenoid cystic carcinoma. This treatment is a compassionate therapy cooperating between our company and the Hospital Affiliated to the National Taiwan University School of Medicine, and is treated by the Hospital Affiliated to the National Taiwan University School of Medicine."

New trial • Oncology • Solid Tumor

[Announcement] Gongxin-KY's acting subsidiary Gongxin Pharmaceutical Technology Co., Ltd. has been approved by Taiwan's Ministry of Health and Welfare to implement the new drug PTS100 at Kaohsiung Veterans General Hospital for the treatment of patients with advanced cholangiocarcinoma. [Google translation] (stock.yahoo) - "On behalf of the subsidiary Gongxin Pharmaceutical Technology Co., Ltd., the new drug PTS100 was implemented by the Kaohsiung Veterans General Hospital for the treatment of patients with advanced cholangiocarcinoma and was approved by the Ministry of Health and Welfare of Taiwan...Our company's subsidiary Gongxin Pharmaceutical Technology Co., Ltd....Received a letter from Taiwan’s Ministry of Health and Welfare, agreeing that Taiwan GX will provide 'PTS100 (Para-Toluenesulfonamide, P-TSA) 330mg/mL, 5mL/amp, 10amp/box' for patients with advanced cholangiocarcinoma, This treatment is a compassionate therapy co-operated by our company and Kaohsiung Veterans General Hospital, and is provided by Kaohsiung Veterans General Hospital."

Trial status • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Gongxin-KY: Taipei Rongzong executive subsidiary PTS100 is approved for the treatment of patients with lung cancer combined with malignant pleural effusion. [Google translation] (MoneyDJ) - "Our company's subsidiary Gongxin Pharmaceutical Technology Co., Ltd...received a letter from Taiwan's Ministry of Health and Welfare, agreeing that Taiwan Gongxin will provide 'PTS100 (Para-Toluenesulfonamide) free of charge , P-TSA) 330mg/mL, 5mL/amp' is for use by patients with lung cancer combined with malignant pleural effusion. This treatment is a compassionate therapy jointly performed by our company and Taipei Veterans General Hospital, and is treated by Taipei Veterans General Hospital."

New trial • Lung Cancer • Oncology • Solid Tumor

Gongxin-KY is tentatively scheduled to be listed in mid-to-late June [Google translation] (Yahoo News) - "According to the current research and development progress...PTS-02, an orphan drug for sexual cancer, is expected to apply for Phase II clinical trials in the third quarter of 2024; PTS100, for the treatment of intermediate and advanced primary liver cancer, is undergoing Phase II clinical patient enrollment at National Taiwan University, Bei Wing, and Beijing Medical University...PTS202 for the treatment of head and neck cancer has completed clinical protocol design."

Clinical protocol • Enrollment status • New P2 trial • Gastrointestinal Cancer • Head and Neck Cancer • Liver Cancer • Oncology • Solid Tumor

Gongxin-KY: Kaohsiung Veterans General Hospital’s executive subsidiary’s new drug PTS100 is approved for the treatment of patients with advanced liver cancer as compassionate therapy [Google translation] (MoneyDJ) - "...Our company's subsidiary Gongxin Pharmaceutical Technology Co., Ltd. (hereinafter referred to as 'Taiwan Gongxin') received a letter from Taiwan's Ministry of Health and Welfare, agreeing that Taiwan Gongxin will provide 'PTS100 (Para-Toluenesulfonamide, P-TSA) free of charge 330mg/mL, 5mL/amp' is used for patients with advanced liver cancer. This treatment is a compassionate therapy cooperating between our company and Kaohsiung Veterans General Hospital, and is treated by Kaohsiung Veterans General Hospital."

Non-US regulatory • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

'New Counter Stocks' Taiwan's new drug PTS100 Compassion Therapy was approved by the Ministry of Health and Welfare [Google translation] (stock.yahoo) - "...Gongxin Pharmaceutical Technology Co., Ltd...announced that Changhua Christian Hospital will implement the new drug PTS100 as a compassionate therapy for the treatment of oral cancer squamous cell carcinoma patients, and it has been approved by the Taiwan Health Commission. Approved by the Ministry of Welfare....Gongxin-KY's subsidiary Gongxin Pharmaceutical Technology Co., Ltd. (Taiwan Gongxin) received a letter from Taiwan's Ministry of Health and Welfare, agreeing that Taiwan Gongxin will provide 'PTS100 (Para-Toluenesulfonamide, P-TSA) Inj.330mg/mL free of charge ,5mL/amp,10amp/box' is for patients with oral cancer squamous cell carcinoma. This treatment is a compassionate therapy jointly provided by Gongxin Company and Changhua Christian Hospital, and is treated by Changhua Christian Hospital."

Non-US regulatory • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor

Para-toluenesulfonamide, a novel potent carbonic anhydrase inhibitor, improves hypoxia-induced metastatic breast cancer cell viability and prevents resistance to αPD-1 therapy in triple-negative breast cancer. (PubMed, Biomed Pharmacother) - "MCF-7 and MDA-MB-231 breast cancer cells were treated with PTS or subjected to hypoxic conditions using cobalt chloride (CoCl), with acetazolamide serving as a positive control. Collectively, our findings suggest that PTS inhibits breast cancer growth and metastasis through the p38 MAPK/ERK1/2 pathway. Moreover, PTS may have the potential to prevent the development of resistance to αPD-1 therapy in breast cancer."

IO biomarker • Journal • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CA9 • HIF1A

'Emerging Counter Stocks' Taiwan Gongwin's new drug PTS100 treats lung cancer and Beirong performs compassionate therapy [Google translation] (stock.yahoo) - "Gongwin-KY...announced that the Ministry of Health and Welfare has approved its subsidiary Taiwan Gongwin to provide 'PTS100 (Para-Toluenesulfonamide, PTSA) 330mg/mL, 5mL/amp' for free for lung cancer combined with malignant pleural effusion. Used by patients, this treatment is a compassionate therapy co-operated by the company and Taipei Veterans General Hospital, and is treated by Taipei Veterans General Hospital."

Non-US regulatory • Lung Cancer • Oncology • Solid Tumor

Effects of Para-Toluenesulfonamide on Canine Melanoma Xenotransplants in a BALB/c Nude Mouse Model. (PubMed, Animals (Basel)) - "PTS and cisplatin were found to have an obvious synergistic tumor-inhibiting effect on canine melanoma. PTS alone and PTS combined with cisplatin may be antitumor agents for canine melanoma treatment."

Journal • Preclinical • Immunology • Inflammation • Melanoma • Oncology • Solid Tumor • Transplantation • CASP3 • mTOR

OASES: A Study of PTS100 in Primary HCC Patients (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Gongwin Biopharm Co., Ltd. | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2021 ➔ Dec 2024

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

[VIRTUAL] FIRST INTERIM RESULTS OF THE RUSSIAN PROSPECTIVE STUDY OF REDUCTION AND DISCONTINUATION TREATMENT OF TKI (READIT) IN CHRONIC MYELOID LEUKEMIA PATIENTS WITH DEEP MOLECULAR RESPONSE (EHA 2021) - "Aims To provide the first interim results of the «Study of REduction And DIscontinuation Treatment of TKI (READIT)» (NCT 04578847): evaluation of the response rates and first data of imatinib (IM) plasma blood concentrations after dose reduction...The TKI dose reduction phase consists of two 6 mo steps: 1st step (300 mg for IM, 400 mg for nilotinib (NIL), 50 mg for dasatinib (DAS) and 300 mg for bosutinib (BOS)) and 2nd step (25 mg for DAS and 200 mg for IM, NIL and BOS) of TKI dose reduction...At baseline 46 (66%) pts received IM (39 pts-400 mg, 3 pts–300 mg, 4 pts–200 mg) and 24 (34%) pts - second-generation (2G) TKI: NIL - 13 pts (6 pts-800-600 mg, 6 pts-400 mg, 1 pt–200 mg), DAS- 6 pts (4 pts-100-70 mg, 2 pts–50 mg), BOS- 5 pts (1 pt–500 mg, 2 pts–300 mg, 2 pts–200 mg)...The results will be updated within a longer follow-up in order to evaluate the impact of de-escalation phase on TFR rates. The role of different TKI concentrations will be studied."

Clinical • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR

Molybdic Acid-Functionalized Nano-Fe3O4@TiO2 as a Novel and Magnetically Separable Catalyst for the Synthesis of Coumarin-Containing Sulfonamide Derivatives. (PubMed, Acta Chim Slov) - "Fe3O4@TiO2@(CH2)3OMoO3H was used as a catalyst for the synthesis of sulfonamide containing coumarin moieties via a three-com-ponent reaction of aryl aldehydes, para-toluenesulfonamide and 4-hydroxycoumarin or 5,7-dihydroxy-4-methylcou-marin. The catalyst recovery test showed the catalyst is highly reusable without losing its activity."

Journal

Amiloride reduces hippocampal neuron death after transient cerebral ischemia (Neuroscience 2018) - "Neuronal death and zinc accumulation were assessed by Fluoro-Jade B (FJB) and N-(6-methoxy-8-quinolyl)-para-toluenesulfonamide (TSQ) staining, respectively, in brains harvested 24 hours after TCI. The present study demonstrates that amiloride attenuates TCI-induced neuronal injury by blockage of intracellular zinc accumulation. Therefore, this study suggests that amiloride may have high therapeutic potential for prevention of TCI-induced neuronal death. "

CNS Disorders • Epilepsy • Vascular Neurology

Para-Toluenesulfonamide Induces Anti-tumor Activity Through Akt-Dependent and -Independent mTOR/p70S6K Pathway: Roles of Lipid Raft and Cholesterol Contents. (PubMed, Front Pharmacol) - "In conclusion, the data suggest that PTS is an effective anti-tumor agent with in vitro and in vivo efficacies through inhibition of both Akt-dependent and -independent mTOR/p70S6K pathways. Moreover, disturbance of lipid raft and cholesterol contents may at least partly explain PTS-mediated anti-tumor mechanism."

IO Biomarker • Journal • Biosimilar • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Cysteine Prevents the Development of Experimental Diabetes Induced by Zinc-Binding Substances. (PubMed, Bull Exp Biol Med) - "Injection of cysteine few minutes after dithizone and formation of zinc-dithizone complex was followed by displacement of dithizone from the complex and prevented the development of diabetes in most animals. The most plausible mechanism of preventive effect of cysteine is the formation of 2:1 zinc-cysteine complex in β cells with possible fixation of Zn atom between sulfur atoms from SH groups of two cysteine molecules."

Journal

"Zheng @NEJM 2018 RCT C7 nerve transfer/rehab vs rehab alone spastic unilat arm paralysis 2/2 cerebral inj >5 y 36 pts 100% 12m f/u graft non-paralyzed -> paralyzed side Fugl myer and ashworth scores and hand fxn all improved in op grp https://t.co/AqC0UvMcaI #neurosurgery" (@MarkMaclean10)

Clinical

OASES: A Phase II Study of PTS100 in Primary HCC Patients (clinicaltrials.gov) - P2; N=33; Recruiting; Sponsor: Gongwin Biopharm Co., Ltd.; Trial completion date: Apr 2022 ➔ Dec 2023; Trial primary completion date: Jul 2019 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date