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.

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