CytRx Receives Recommendation from Data Safety Monitoring Committee to omplete International Phase 2b Trial with Aldoxorubicin

CytRx Corporation CYTR, a biopharmaceutical research and development company specializing in oncology, announced that the independent Data Safety Monitoring Committee (DSMC) overseeing the Company's international Phase 2b clinical trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion. This Phase 2b trial allows for a head-to-head clinical comparison of the commonly used chemotherapeutic agent doxorubicin with aldoxorubicin, CytRx's tumor-targeting doxorubicin conjugate. Doxorubicin is dose-limited at a level below its maximum anti-tumor capabilities due to toxicity, including cardiotoxicity. Data from the Phase 2b trial is expected in the second half of 2013. “The recommendation to complete the Phase 2b trial indicates that the DSMC found no significant safety issues with aldoxorubicin, even though the dose of aldoxorubicin administered in this trial delivers doxorubicin at three-and-a-half times its standard dose,” said CytRx CEO Steven A. Kriegsman. “The DSMC was not charged with evaluating efficacy at this point in the study. Aldoxorubicin combines doxorubicin with our proprietary linker technology. This platform technology includes a single molecule that, when attached to a chemotherapeutic agent, allows for concentration of the agent at the tumor site, thus allowing for greater drug infusion into the tumor. We believe that safely concentrating more drug at the tumor site could improve the drug's effectiveness. “Aldoxorubicin is the first drug we are evaluating in the clinic based on the linker technology. Doxorubicin was selected for evaluation as it is well-known and has been used by the medical community for decades; however the linker has broad potential utility with proven affinity to couple with multiple chemotherapeutic agents including paclitaxel, docetaxel, cisplatin, irinotecan and methotrexate. Each of these agents may be incorporated into our future clinical development plans,” he added. The Phase 2b trial is enrolling a total of 105 patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy and are ineligible for surgery. Patients in the trial are randomized into two groups, with twice as many receiving aldoxorubicin as doxorubicin. The trial's primary objective is to compare progression-free survival between each group. Secondary endpoints include evaluating tumor response and overall patient survival, and assessing the safety of aldoxorubicin compared with doxorubicin in this patient population through a number of indicators, including the frequency and severity of adverse events. Patients are being enrolled in clinical sites in the U.S., Hungary, Romania, Russia, Ukraine, India and Australia. CytRx holds exclusive worldwide rights to aldoxorubicin, as well as option rights to the protein-binding platform technology that serves as the linker with doxorubicin.