(NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that it has reached the targeted enrollment of 105 evaluable patients in its international Phase 2b clinical trial with aldoxorubicin as a first-line treatment for soft tissue sarcoma. This trial allows for a head-to-head clinical comparison of the efficacy and safety of the commonly used chemotherapeutic agent doxorubicin with aldoxorubicin, CytRx’s improved version of doxorubicin.
“Achieving this key milestone puts us on track to report highly anticipated progression-free survival data from the Phase 2b clinical trial in the second half of 2013,” said Steven A. Kriegsman, CytRx President and CEO. “Doxorubicin is a well-known chemotherapy drug, having been used by the medical community for decades, and it is the current standard of care for advanced, metastatic soft tissue sarcoma as well as numerous other cancers. Doxorubicin, however, has many side effects, including potential damage to the heart muscle. These side effects limit the dosage of doxorubicin to a level below its maximum anti-tumor capabilities.
“Aldoxorubicin is formulated using a novel linker technology designed to safely deliver higher concentrations of doxorubicin directly to tumors, which could improve effectiveness while reducing toxicity. In fact, the Phase 2b clinical trial is comparing a dose of aldoxorubicin that delivers doxorubicin at 3.5 times the dose of doxorubicin in the comparator arm of the trial,” he added. “Last month, the independent Data Safety Monitoring Committee overseeing the Phase 2b trial recommended conducting the trial to completion, indicating that the Committee had found no significant safety issues with aldoxorubicin, even at this high dose.”
In the Phase 2b clinical trial, patients with metastatic locally advanced or unresectable soft tissue sarcoma who have not been previously treated with any chemotherapy are randomized into two groups with twice as many receiving aldoxorubicin as doxorubicin. In addition to the primary objective of measuring median progression-free survival, the Phase 2b trial will evaluate tumor response and overall patient survival. The trial is being conducted at clinical sites in the U.S., Hungary, Romania, Russia, Ukraine, India and Australia.