CytRx rockets on strong new data for sarcoma drug aldoxorubicin

The release of much anticipated new data by US biotech firm CytRx Corp (Nasdaq: CYTR) on its investigation drug aldoxorubicin saw the company’s shares leap 65% to $3.95 in pre-market trading yesterday.

CytRx announced highly positive top-line efficacy results from a multicenter, randomized, open-label global Phase IIb clinical trial investigating the efficacy of aldoxorubicin compared with doxorubicin in subjects with first-line metastatic, locally advanced or unresectable soft tissue sarcomas (STS), in which aldoxorubicin demonstrated 80%-100% superiority over doxorubicin in progression-free survival as first-line therapy in advanced soft tissue sarcomas.

In an intent-to-treat analysis, the investigator-assessed median PFS was 8.4 months for aldoxorubicin patients versus 4.7 months for doxorubicin patients (p=0.0002), while the blinded central lab review indicated that median PFS for aldoxorubicin patients was 5.7 months versus 2.8 months for doxorubicin patients (p=0.018). Per investigators, 67.1% of aldoxorubicin patients had not progressed at 6 months, compared with 36.1% of doxorubicin-treated patients (p=0.005). By blinded central lab review, 46.8% of aldoxorubicin patients had not progressed at 6 months, compared with 23.7% of doxorubicin patients (p=0.038).