Aldoxorubicin

CytRx linker Technology

Doxorubicin and the liposomal version Doxil are common chemotherapy agents used for soft tissue sarcoma.  Doxorubicin is dose limited due to adverse effects on cardiac tissue.  Doxil typically does not affect cardiac tissue but causes sores in the mouth and skin reactions on the hands and feet.

CytRx has been conducting clinical trials on the efficacy of Aldoxorubicin compared to Doxorubicin.  In one study Progession Free Survival (PFS) rates were double that with standard Doxorubicin without the cardiac side effects.

Aldoxorubicin has been granted orphan drug designation by the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) for the treatment of patients with soft tissue sarcomas and pancreatic cancer.

Clinical Trials

CytRx has initiated under a Special Protocol Assessment, or SPA,granted by the U.S. Food and Drug Administration, a pivotal Phase 3 global trial of aldoxorubicin as a therapy for patients with soft tissue sarcoma whose tumors have progressed following treatment with chemotherapy, and recently announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial.

In a recent clinical trial, aldoxorubicin was found to be similar in effectiveness to the physicians choice for treatment.  

No word yet on when the drug will be available as part of the standard treatment of care.