The German Federal Institute for Drugs and Medical Devices (BfArM) and the responsible Ethics Committee have granted approval for Thermosome to conduct a first-in-human Phase I trial with THE001 in Germany.
In the trial, the new compound for targeted tumour therapy will be assessed in soft tissue sarcoma patients.
The determination of the maximum tolerated dose, and THE001’s safety and tolerability are the primary endpoints of the open-label, interventional dose-escalation Phase I trial. The trial’s secondary objective is to assess the anti-tumour activity of THE001.
In the trial, participants will be recruited at two clinical sites, Helios Klinikum Berlin-Buch and LMU Klinikum, Munich, in Germany, which are specialised in soft tissue sarcoma (STS) patients’ treatment.
The enrolment of participants is anticipated to begin in the second quarter of this year.
Thermosome co-founder and CEO/ chief financial officer Dr Pascal Schweizer said: “This study is an important milestone for our company and the result of a strong team effort.
“We know from preclinical studies in soft tissue sarcoma that our approach results in significantly improved local efficacy by providing a local boost at the desired site of action.”
The company’s lead programme, THE001, is a thermosensitive liposomal formulation of the chemotherapeutic drug doxorubicin (DPPG2-TSL-DOX) and has a different mode of action compared to conventional liposomes.
Its technology enables intravascular drug release by a mild heat trigger using hyperthermia devices that are clinically established.
Helios Klinikum Berlin-Buch sarcoma and hyperthermia expert and study principal investigator Dr Peter Reichardt said: “I believe that Thermosome´s approach has the potential to change the standard of care for locally advanced soft tissue sarcomas, and I am excited to evaluate THE001 in a clinical setting in an indication with such a high unmet medical need.”