Latest news with #RHT
Business Upturn
24-06-2025
- Health
- Business Upturn
Thermosome Reports Encouraging Clinical Data of THE001 in Advanced Soft Tissue Sarcomas
Heat-triggered release mechanism unequivocally confirmed Favorable safety profile with good tolerability Signs of encouraging clinical activity in heavily pre-treated patients including meaningful progression-free survival (PFS) One participant with previously unresectable disease in DL2 underwent surgery, indicating no vital tumor cells in the target lesion Munich, Germany – June 24, 2025 – Thermosome GmbH, a clinical-stage drug development company focused on targeted tumor therapies, today announced new, encouraging data from its ongoing Phase I clinical trial evaluating its lead compound THE001 (DPPG 2 -TSL-DOX) in combination with regional hyperthermia (RHT) for the treatment of soft tissue sarcomas (STS). The Phase I study is assessing the safety, pharmacokinetics (PK), and preliminary efficacy of THE001 + RHT in participants with locally advanced unresectable or metastatic STS, who have exhausted all prior treatment options, including standard doxorubicin (DOX). Despite the early stage of development and a small number of participants, signs of meaningful clinical activity have emerged. Among the heavily pre-treated participants – including patients pre-treated with DOX – the median progression-free survival (PFS) following treatment with THE001 + RHT reached 4.5 months across both dose levels (20 and 40 mg/m²). This exceeds the typical median PFS of 2.7 to 3.5 months observed with first-line DOX therapy in treatment-naïve patients at DOX doses of 75 mg/m2, i.e., 2-4x higher than doses of THE001 applied in the Phase I setting. At dose level 2 (40 mg/m²), the mean PFS reached 7.1 months. Two out of three participants in this dose level achieved a partial response (PR) according to Choi criteria and completed the maximum extended treatment phase of 12 cycles (~8.3 months). Notably, one participant whose tumor was initially considered unresectable, could undergo surgical resection at the end of the extended study treatment. This participant showed a tumor shrinkage of -16% in the sum of target lesions, a partial response according to Choi criteria and no vital tumor cells in the resected target lesion. Across dose levels 1 and 2, THE001 + RHT demonstrated a favorable safety profile. There were no dose-limiting toxicities or high-grade treatment-related adverse events that led to treatment discontinuation, underscoring the good tolerability of THE001 in combination with RHT. 'These findings not only provide consistent proof of the galenic concept of heat-triggered, largely complete DOX release from THE001, but also demonstrate clinical benefit in a highly challenging patient population,' said Dr. Frank Hermann, Chief Medical Officer of Thermosome. 'We are particularly encouraged by the results of one participant who underwent resection after 12 full treatment cycles with THE001 and regional hyperthermia with no vital tumor cells found in the resected target lesion. These results clearly support future exploration in the neoadjuvant setting.' Alexander Eggermont, Professor of Clinical and Translational Immunotherapy, University Medical Center, Utrecht, and a member of Thermosome´s Clinical Advisory Board, commented: 'The Phase I data of THE001, a thermosensitive liposomal DOX, and regional hyperthermia in heavily pre-treated DOX-experienced soft tissue sarcoma patients, particularly from dose level 2, are very encouraging. These results demonstrate the clinical potential of this highly innovative approach and provide the necessary foundation for transitioning into Phase II proof-of-concept development. I am excited to support this important work and look forward to advancing this promising therapy, which has the potential to significantly improve outcomes for patients with soft tissue sarcoma, particularly in the neoadjuvant setting.' 'It is exciting to see the promising results of THE001 combined with regional hyperthermia, demonstrating strong potential to address the high unmet need for better treatments for soft tissue sarcoma,' added Prof. Shreyaskumar Patel, the Robert R. Herring Distinguished Professor of Medicine and Medical Director of the Sarcoma Center at The University of Texas MD Anderson Cancer Center, Houston Texas, and a member of Thermosome's Clinical Advisory Board. 'Expansion into Phase II, also including the U.S., would offer a much-needed validation of this new therapeutic strategy for patients with STS. I look forward to supporting the advancement of this innovative treatment option to improve outcomes for patients here in the U.S. and globally on the back of the orphan drug designation granted by the FDA.' Considering supportive feedback from the German Federal Institute for Drugs and Medical Devices (BfArM) on the development of THE001 + RHT in the neoadjuvant setting, the available data from last-line participants are intended to support further development in the neoadjuvant setting. ### About Thermosome Thermosome is a clinical-stage drug development company focused on targeted tumor therapy combined with immune stimulation for improved cancer therapy. At its core is a novel, proprietary tumor targeting approach that allows for significantly increased local drug concentration and improved tumor penetration to achieve improved clinical treatment efficacy. The first clinical indication for its lead drug candidate THE001 is soft tissue sarcoma, where the Company aims to improve the current standard of care (free doxorubicin). Thermosome's approach enables targeted tumor treatment independent of specific molecular targets and covers patient populations across all chemo-sensitive tumor subtypes. More information: About THE001 Thermosome's clinical-stage lead drug candidate THE001 is a thermosensitive liposomal formulation of the chemotherapeutic drug doxorubicin (DPPG 2 -TSL-DOX). It has a different mode of action than conventional liposomes. Thermosome's technology enables intravascular drug release initiated by a mild heat trigger using clinically established hyperthermia devices. This results in up to 15-fold higher local drug concentrations in the tumor and aims to improve clinical treatment efficacy by creating a local boost at the desired site of action. These high local concentrations, which also reach less well perfused areas, are intended to overcome drug resistance. This effect cannot be achieved by administration of conventional doxorubicin due to systemic toxicity. Thermosome intends to further enhance treatment efficacy through an additive immune response induced by regional hyperthermia. THE001 has potential for further development in other anthracycline-sensitive solid tumors, such as breast, bladder, and ovarian cancer. THE001 has been granted Orphan Drug Designation for STS in Europe and the United States. About the Phase I Study The Phase I, open-label, interventional dose-escalation trial enrolling patients with (including DOX-) pre-treated locally advanced unresectable or metastatic STS (NCT05858710) is being conducted at two German clinical sites testing THE001 at various different dose levels in initially up to 6 cycles every 3 weeks with option to extend to up to 12 cycles in participants with at least disease control. Both completed dose level (20 mg/m² and 40 mg/m²) were well tolerated and declared safe by the independent data safety monitoring board (DSMB). Primary endpoints of the study are the safety and tolerability of THE001 and the determination of the maximum tolerated dose. A secondary objective is the evaluation of anti-tumor activity. Initial clinical data were presented at the CTOS 2024 Annual Meeting (link). About Soft Tissue Sarcomas (STS) STS is an atypical tumor with a patient population that includes many young patients. Locally advanced STS (LA-STS) are large invasive tumors that are difficult or impossible to resect. Neoadjuvant therapy is used to shrink these tumors preoperatively to allow tumor surgery with curative intent. Free doxorubicin in combination with ifosfamide or dacarbazine has been the gold standard for neoadjuvant therapy of all chemo-sensitive LA-STS for several decades. Guidelines also recommend combining DOX-based therapy with regional hyperthermia. However, with response rates of less than 30%, there is a significant unmet need for improved treatment options. Soft tissue sarcomas occur in more than 50 different subtypes that do not share a common driver mutation, making biologic targeting more difficult than physically controlled targeting with the most active agent. Company ContactThermosome GmbHAm Klopferspitz 1982152 Planegg/Martinsried (Germany)Phone: +49 89 7167760 31 [email protected]
Associated Press
24-06-2025
- Business
- Associated Press
Thermosome Reports Encouraging Clinical Data of THE001 in Advanced Soft Tissue Sarcomas
Munich, Germany – June 24, 2025 – Thermosome GmbH, a clinical-stage drug development company focused on targeted tumor therapies, today announced new, encouraging data from its ongoing Phase I clinical trial evaluating its lead compound THE001 (DPPG2-TSL-DOX) in combination with regional hyperthermia (RHT) for the treatment of soft tissue sarcomas (STS). The Phase I study is assessing the safety, pharmacokinetics (PK), and preliminary efficacy of THE001 + RHT in participants with locally advanced unresectable or metastatic STS, who have exhausted all prior treatment options, including standard doxorubicin (DOX). Despite the early stage of development and a small number of participants, signs of meaningful clinical activity have emerged. Among the heavily pre-treated participants – including patients pre-treated with DOX – the median progression-free survival (PFS) following treatment with THE001 + RHT reached 4.5 months across both dose levels (20 and 40 mg/m²). This exceeds the typical median PFS of 2.7 to 3.5 months observed with first-line DOX therapy in treatment-naïve patients at DOX doses of 75 mg/m2, i.e., 2-4x higher than doses of THE001 applied in the Phase I setting. At dose level 2 (40 mg/m²), the mean PFS reached 7.1 months. Two out of three participants in this dose level achieved a partial response (PR) according to Choi criteria and completed the maximum extended treatment phase of 12 cycles (~8.3 months). Notably, one participant whose tumor was initially considered unresectable, could undergo surgical resection at the end of the extended study treatment. This participant showed a tumor shrinkage of -16% in the sum of target lesions, a partial response according to Choi criteria and no vital tumor cells in the resected target lesion. Across dose levels 1 and 2, THE001 + RHT demonstrated a favorable safety profile. There were no dose-limiting toxicities or high-grade treatment-related adverse events that led to treatment discontinuation, underscoring the good tolerability of THE001 in combination with RHT. 'These findings not only provide consistent proof of the galenic concept of heat-triggered, largely complete DOX release from THE001, but also demonstrate clinical benefit in a highly challenging patient population,' said Dr. Frank Hermann, Chief Medical Officer of Thermosome. 'We are particularly encouraged by the results of one participant who underwent resection after 12 full treatment cycles with THE001 and regional hyperthermia with no vital tumor cells found in the resected target lesion. These results clearly support future exploration in the neoadjuvant setting.' Alexander Eggermont, Professor of Clinical and Translational Immunotherapy, University Medical Center, Utrecht, and a member of Thermosome´s Clinical Advisory Board, commented: 'The Phase I data of THE001, a thermosensitive liposomal DOX, and regional hyperthermia in heavily pre-treated DOX-experienced soft tissue sarcoma patients, particularly from dose level 2, are very encouraging. These results demonstrate the clinical potential of this highly innovative approach and provide the necessary foundation for transitioning into Phase II proof-of-concept development. I am excited to support this important work and look forward to advancing this promising therapy, which has the potential to significantly improve outcomes for patients with soft tissue sarcoma, particularly in the neoadjuvant setting.' 'It is exciting to see the promising results of THE001 combined with regional hyperthermia, demonstrating strong potential to address the high unmet need for better treatments for soft tissue sarcoma,' added Prof. Shreyaskumar Patel, the Robert R. Herring Distinguished Professor of Medicine and Medical Director of the Sarcoma Center at The University of Texas MD Anderson Cancer Center, Houston Texas, and a member of Thermosome's Clinical Advisory Board. 'Expansion into Phase II, also including the U.S., would offer a much-needed validation of this new therapeutic strategy for patients with STS. I look forward to supporting the advancement of this innovative treatment option to improve outcomes for patients here in the U.S. and globally on the back of the orphan drug designation granted by the FDA.' Considering supportive feedback from the German Federal Institute for Drugs and Medical Devices (BfArM) on the development of THE001 + RHT in the neoadjuvant setting, the available data from last-line participants are intended to support further development in the neoadjuvant setting. ### About Thermosome Thermosome is a clinical-stage drug development company focused on targeted tumor therapy combined with immune stimulation for improved cancer therapy. At its core is a novel, proprietary tumor targeting approach that allows for significantly increased local drug concentration and improved tumor penetration to achieve improved clinical treatment efficacy. The first clinical indication for its lead drug candidate THE001 is soft tissue sarcoma, where the Company aims to improve the current standard of care (free doxorubicin). Thermosome's approach enables targeted tumor treatment independent of specific molecular targets and covers patient populations across all chemo-sensitive tumor subtypes. More information: About THE001 Thermosome's clinical-stage lead drug candidate THE001 is a thermosensitive liposomal formulation of the chemotherapeutic drug doxorubicin (DPPG2-TSL-DOX). It has a different mode of action than conventional liposomes. Thermosome's technology enables intravascular drug release initiated by a mild heat trigger using clinically established hyperthermia devices. This results in up to 15-fold higher local drug concentrations in the tumor and aims to improve clinical treatment efficacy by creating a local boost at the desired site of action. These high local concentrations, which also reach less well perfused areas, are intended to overcome drug resistance. This effect cannot be achieved by administration of conventional doxorubicin due to systemic toxicity. Thermosome intends to further enhance treatment efficacy through an additive immune response induced by regional hyperthermia. THE001 has potential for further development in other anthracycline-sensitive solid tumors, such as breast, bladder, and ovarian cancer. THE001 has been granted Orphan Drug Designation for STS in Europe and the United States. About the Phase I Study The Phase I, open-label, interventional dose-escalation trial enrolling patients with (including DOX-) pre-treated locally advanced unresectable or metastatic STS ( NCT05858710 ) is being conducted at two German clinical sites testing THE001 at various different dose levels in initially up to 6 cycles every 3 weeks with option to extend to up to 12 cycles in participants with at least disease control. Both completed dose level (20 mg/m² and 40 mg/m²) were well tolerated and declared safe by the independent data safety monitoring board (DSMB). Primary endpoints of the study are the safety and tolerability of THE001 and the determination of the maximum tolerated dose. A secondary objective is the evaluation of anti-tumor activity. Initial clinical data were presented at the CTOS 2024 Annual Meeting ( link ). About Soft Tissue Sarcomas (STS) STS is an atypical tumor with a patient population that includes many young patients. Locally advanced STS (LA-STS) are large invasive tumors that are difficult or impossible to resect. Neoadjuvant therapy is used to shrink these tumors preoperatively to allow tumor surgery with curative intent. Free doxorubicin in combination with ifosfamide or dacarbazine has been the gold standard for neoadjuvant therapy of all chemo-sensitive LA-STS for several decades. Guidelines also recommend combining DOX-based therapy with regional hyperthermia. However, with response rates of less than 30%, there is a significant unmet need for improved treatment options. Soft tissue sarcomas occur in more than 50 different subtypes that do not share a common driver mutation, making biologic targeting more difficult than physically controlled targeting with the most active agent. Company Contact Thermosome GmbH Am Klopferspitz 19 82152 Planegg/Martinsried (Germany) Phone: +49 89 7167760 31 [email protected] Media Inquiries akampion Dr. Ludger Wess / Ines-Regina Buth, Managing Partners [email protected] Phone: +49 40 88 16 59 64 / +49 30 23 63 27 68
Scottish Sun
24-04-2025
- Business
- Scottish Sun
Scots worker wins thousands after boss branded him shocking homophobic slur
Colleagues tried to pass off the comments as "banter" Click to share on X/Twitter (Opens in new window) Click to share on Facebook (Opens in new window) A GAY removal firm worker has won more than £5,000 after his boss called him a 'wee w*****r'. Sean McGhie's supervisor closed a door on him while he was carrying heavy boxes of paper and called him 'Mr Clean' because he took care of his well groomed appearance, an employment tribunal heard. Sign up for Scottish Sun newsletter Sign up 1 PHFA7P Employment tribunal documents, note pad and glasses. Brian Donaldson - who was upset that he had been reported to bosses - also deliberately targeted the 36-year-old by leaving him out when buying food for colleagues from a burger van, the panel concluded. Mr McGhie successfully sued RHT Scotland for harassment and victimisation and has now been awarded £5,500 in compensation. The tribunal, held in Glasgow, heard that Mr McGhie started working for RHT in August 2023 in Inverkeithing in Fife as a fitter. It heard: 'He makes no secret of the fact that he is gay. He was comfortable discussing aspects of his sexuality with fellow employees. 'The fact that he was gay prompted male colleagues to ask him questions about his sex life and to discuss theirs. 'There was often such 'banter' between employees which [he] participated in relating to explicit sexual matters.' However, the tribunal heard Mr McGhie felt he was bullied by Mr Donaldson, who called him 'Mr Clean' because he 'took an interest in his appearance', regularly cleaning and washing his clothes. In October 2023, Mr McGhie and Mr Donaldson worked together at a site in Glasgow. The tribunal heard that the colleagues had an argument about commuting to work. It was told: 'In the course of the argument [Mr Donaldson] referred to Mr McGhie as 'You wee w*****r……'. '[Mr McGhie] was taken aback and shocked at this comment. 'He asked [Mr Donaldson] to repeat it which he then did slowly and deliberately emphasising the words and looking [Mr McGhie] in the face. '[He] responded by saying that's uncalled for' and left [Mr Donaldson]'s presence.' Mr McGhie felt 'mortified' by the incident, and reported it, the tribunal heard. He said: 'The intent of this comment was to insult and it resulted in me walking off a job.' Mr Donaldson argued that the remark was 'banter' and that he had used it as he 'thought it may defuse the situation'. However, he eventually apologised for making a 'homophobic slur'. The following month, however, the tribunal heard he pulled a door closed as Mr McGhie - who he referred to as a 'grass' - approached it carrying heavy boxes of paper. In the same month, he said 'It f*****g stinks in here' while looking at Mr McGhie as he walked into a room which smelt strongly of onions, the panel was told. And on another occasion he bought everyone at work something from a burger van except Mr McGhie. Scots prison offers 'facing punishment' if they call trans rapists male The tribunal heard that another employee at the firm, referred to only as AR, shouted at him at work: 'Where are you you gay c**t!'. After Mr McGhie complained about their behaviour - which he also reported to the police - RHT disciplined AR, but found that his allegations against Mr Donaldson had no basis. He was dismissed in January 2024 for unrelated reasons and took the company to the tribunal claiming harassment and victimisation. The panel found that although his claim regarding the 'wee w*****r' comment had been made too late for the tribunal to consider it, Mr Donaldson has victimised Mr McGhie after he complained about it. Mr McGhie was awarded £2,500 for the victimisation carried out by Mr Donaldson and £3,000 for AR's act of harassment.
