CytRx commences aldoxorubicin plus doxorubicin Phase 1b trial in advanced solid tumors

The single-center Phase 1b clinical trial will be conducted under the direction of Dr. Chawla and will enroll up to 24 patients. Doxorubicin will be administered at 50% of its maximum tolerated dose in combination with escalating doses of aldoxorubicin to determine the maximum tolerated dose of the combination of these two drugs in this patient population.

In June, CytRx reported results for a Phase 1b/2 clinical trial indicating that aldoxorubicin administered at its maximum tolerated dose showed clinical benefit (defined as partial response and stable disease of more than four months following up to eight cycles of treatment) in 10 of 13 (77%) evaluable patients with relapsed or refractory soft tissue sarcoma. All patients in the Phase 1b/2 trial had either not responded to or relapsed after treatment with between one and three prior chemotherapy regimens. Based on the results of this trial CytRx plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy.

"We are delighted that such a distinguished sarcoma expert as Dr. Chawla has agreed to serve as principal investigator for yet another trial with aldoxorubicin," said CytRx CEO Steven A. Kriegsman. "Dr. Chawla led our Phase 1b/2 clinical trial with aldoxorubicin in patients with advanced solid tumors and presented clinical results from this trial at the American Society of Clinical Oncology (ASCO) conference last month. He also is leading our global Phase 2b clinical trial designed to compare aldoxorubicin head-to-head with doxorubicin as a first-line treatment for patients with advanced soft tissue sarcoma. Enrollment completion and data analysis are expected for this trial in 2013."