Gemin X Biotechnologies has announced that results from a Phase I clinical trial of GX15-070 in patients with refractory solid tumors and lymphomas showed the compound to be generally well-tolerated at doses resulting in biological activity.
The clinical trial enrolled 18 patients with refractory solid tumors or lymphomas who had failed a median of four prior types of treatment. All patients were treated with GX15-070 at doses ranging from 5 mg/m2 to 20 mg/m2 administered as a three-hour, weekly infusion in four week cycles. Clinical responses achieved to date include six patients with stable disease from 15 to 47 weeks. Biological responses include a mean increase in plasma oligonucleosomal DNA levels of 7-fold over baseline, indicating successful induction of apoptosis. Additionally, Cmax and AUC were dose-proportional. Adverse events were mostly observed during or shortly after infusion and were transient. Side effects commonly associated with cancer treatments including neutropenia, thrombocytopenia or lymphopenia were not observed.