In the Phase I portion of the DIGNITY study, a highly treatment-refractory BCRCW patient population was treated using ThermoDox® in combination with MLH for superficial lesions < 3cm depth that have failed standard treatment. The study was designed to determine the Maximum Tolerated Dose (MTD) or confirm 50 mg/m2 as acceptable, evaluate safety, Sparse PK sampling, and determine early effects of ThermoDox® in combination with MLH. A total of 11 subjects were treated. Drug Related Adverse Events were consistent with the known safety profile of doxorubicin including myelosuppression, alopecia, fatigue, and nausea. Reversible myelosuppression was the most frequently observed effect, effectively managed with ASCO g-CSF treatment recommendations. Clinically meaningful responses were observed, including a target lesion response rate of 45% without local progression (complete
response 9.1%, n=1/11, partial response 36.4%, n=4/11). The study found that 50 mg/m2 is the acceptable Phase 2 dose, as determined by independent review. Based on these results,
Professor Rugo commented, "BCRCW patients, who in this study had an average of over four prior regimens, often have limited or no treatment options, underscoring a significant unmet medical need in this population. The initial experience with hyperthermia and ThermoDox® demonstrates the tolerability of the regimen in these patients as well as early efficacy signals, providing strong support for moving into a larger study."
"Breast cancer recurrence at the chest wall has a poor prognosis, is difficult to treat and is characterized by disfigurement, pain, and restriction of movement. These results, therefore, particularly in such highly refractory patients, are encouraging," said
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Professor Rugo's presentation of data from the DIGNITY Study comes at a very poignant time for BCRCW patients.
About ThermoDox® and the Phase III HEAT Study
ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. In the HEAT Study, ThermoDox® is administered intravenously in combination with Radio Frequency Ablation (RFA). Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
For primary liver cancer, ThermoDox® is being evaluated in a global, multi-center, randomized, pivotal Phase III HEAT Study at 79 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival with a secondary confirmatory endpoint of overall survival. Additional information on the Company's ThermoDox® clinical studies may be found at www.clinicaltrials.gov.
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