On May 5, 2014 CytRx reported updated progression-free survival (PFS) and overall survival (OS) results from its completed Phase 1b/2 clinical trial (NCT01514188) of aldoxorubicin in patients with advanced soft tissue sarcoma (STS) (Press release CytRx, MAY 5, 2014, View Source;p=RssLanding&cat=news&id=1925718 [SID:1234500486]).
Data from the Phase 1b/2 trial demonstrated that aldoxorubicin administered at its maximum tolerated dose (350mg/m2) showed a substantial increase in median PFS in patients with advanced soft tissue sarcoma (n=13). Partial responses were observed in 5 of 13 patients (38%) and stable disease was observed in 6 of 13 patients (46%). Median PFS of 6.4 months was initially reported at ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper); in the final reported data, observed median PFS had nearly doubled to 11 months, and median OS was 17 months. Notably, following 8 cycles of aldoxorubicin, two patients experienced no progression of disease for 23 and 15 months, respectively, despite no further treatment. Aldoxorubicin was generally well tolerated with no observed cardiotoxicities and no drug-related deaths.

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Aldoxorubicin is currently being studied in a pivotal global Phase 3 clinical trial evaluating the efficacy and safety of aldoxorubicin as a second-line treatment for patients with STS under a Special Protocol Assessment with the FDA. CytRx is also conducting two Phase 2 clinical trials evaluating aldoxorubicin in patients with late-stage glioblastoma (GBM) and HIV-related Kaposi’s sarcoma.