Final Dose Level Initiated in Ph 1 Trial of THE001
“After observing early signs of efficacy in our ongoing trial, this is another important milestone for our company, as it proves that THE001 can be administered safely,“ said Dr. Frank Hermann, CMO of Thermosome. “Of note, there were no signs of renal or cardiac impairment and no dedicated formulation-related adverse events such as infusion-related reactions due to the innovative liposomal formulation. No trial participant had to discontinue treatment due to adverse events. Together with the previously reported pharmacokinetic and anti-tumor activity data, the overall data from the trial look very encouraging as of now. They underline the great potential of THE001 plus regional hyperthermia in STS as a tolerable, innovative treatment modality that has significantly improved local clinical activity with non-inferior systemic exposure to doxorubicin, but with a favorable pharmacokinetic profile.“
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