FDA Grants Aldoxorubicin Orphan Drug Designation

CytRx announced that the FDA has granted multiple Orphan Drug designations to aldoxorubicin for glioblastoma multiforme, small cell lung cancer, and ovarian cancer. Aldoxorubicin is a modified version of the chemotherapeutic agent, doxorubicin combined with a novel single-molecule linker that binds directly to circulating albumin.

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 soft tissue sarcoma (STS). CytRx is also evaluating aldoxorubicin in two Phase 2 clinical trials, one in patients with late-stage GBM and the other in HIV-related Kaposi's sarcoma.

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CytRx plans to initiate a global Phase 2b trial in patients with relapsed small cell lung cancer this month and is undertaking a Phase 1b combination study of aldoxorubicin plus gemcitabine as a potential precursor to a trial in relapsed ovarian cancer.

For more information visit CytRx.com.