(NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced the initiation of a Phase 1b clinical trial to determine the maximum tolerated dose and to evaluate preliminary efficacy of aldoxorubicin (formerly INNO-206) administered in combination with the commonly used chemotherapeutic agent doxorubicin in patients with advanced solid tumors who have failed other therapies. Aldoxorubicin is a tumor-targeting conjugate of doxorubicin.
“Recent trials conducted by Dr. Felix Kratz of the Tumor Biology Institute in Freiburg, Germany using animal models of human tumors showed that the combination of aldoxorubicin and free doxorubicin administered at 50% each of their respective maximum tolerated dose provided complete and prolonged remissions in ovarian and pancreatic cancers with minimal weight loss compared with each drug administered individually at its maximum tolerated dose,” said Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, Calif. “Given these favorable results, the combination of aldoxorubicin plus doxorubicin warrants further evaluation as a treatment for patients with 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.