CytRx has begun a Phase 1b trial with combination of aldoxorubicin (INNO-206) and doxorubicin in patients with advanced solid tumours.

The trial is designed to determine the maximum tolerated dose and to evaluate preliminary efficacy of aldoxorubicin administered in combination with the commonly used chemotherapeutic agent doxorubicin.

The Sarcoma Oncology Center in Santa Monica, California, director and the study’s principal investigator Dr. Sant Chawla said 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.

"Given these favorable results, the combination of aldoxorubicin plus doxorubicin warrants further evaluation as a treatment for patients with solid tumors," Dr. Chawla added.

The single-center Phase 1b trial of aldoxorubicin, a tumor-targeting conjugate of doxorubicin, will enroll up to 24 patients with advanced solid tumors who have failed other therapies.

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 the patient population.

CytRx CEO Steven Kriegsman said Dr. Chawla led Phase 1b/2 clinical trial with aldoxorubicin in patients with advanced solid tumors and presented clinical results from the trial at the American Society of Clinical Oncology (ASCO) conference.

"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," Dr. Chawla added.