Thermosome Advances to Higher Dosage in THE001 Phase I Clinical Trial

Thermosome, a company based in Munich, Germany, has received approval from the Data Safety Monitoring Board (DSMB) to continue with the planned dosage increase in its Phase I clinical trial for THE001, a targeted tumor therapy. The DSMB has deemed the first dosage level of 20mg/m2 to be safe and well-tolerated by patients.
The ongoing Phase I trial, which is open-label and interventional, is recruiting patients with advanced or inoperable soft tissue sarcomas at Helios Klinikum Berlin-Buch and LMU Klinikum, Munich. THE001 is being tested at three dosage levels, with the second level set at 40mg/m2. The primary goals of the study are to assess the safety and tolerability of THE001 and to determine the maximum tolerated dose. Additionally, the study aims to evaluate the drug's anti-tumor effects.
Dr. Frank Hermann, Chief Medical Officer of Thermosome, expressed satisfaction with reaching the second dosage level and highlighted the importance of the DSMB's assessment. Prof. Dr. Peter Reichardt, the trial's Principal Investigator and a leading oncologist, noted the poor prognosis and treatment challenges associated with soft tissue sarcomas, emphasizing the need for more effective therapies.
Thermosome specializes in developing drugs for targeted tumor therapy with immune stimulation to enhance cancer treatment. Their proprietary approach aims to increase local drug concentrations and improve tumor penetration, thereby improving clinical efficacy. THE001 is a thermosensitive liposomal formulation of doxorubicin, designed to release the drug intravascularly upon mild heat stimulation, leading to higher local drug concentrations and potentially overcoming drug resistance. The drug candidate has potential applications in other solid tumors sensitive to anthracyclines, such as breast, bladder, and ovarian cancer.
Soft tissue sarcomas are aggressive tumors that are challenging to treat, with current therapies showing a response rate of less than 30%. THE001 has received European Orphan Drug Designation for the treatment of STS, indicating its potential to address an unmet medical need in this area.

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