CytRx Initiates Phase 2 Trial With Aldoxorubicin In Brain Cancer Patients

(RTTNews) - CytRx Corp. (CYTR) announced Wednesday that it has initiated Phase 2 clinical trial with its aldoxorubicin for the treatment of unresectable glioblastoma multiforme or GBM, a deadly form of brain cancer.

The open-label, multi-center study is designed to investigate the preliminary efficacy and safety of aldoxorubicin in subjects with unresectable GBM whose tumors have progressed following prior treatment with surgery, radiation and temozolomide.

The company expects that the clinical trial will enroll up to 28 subjects randomly assigned equally to two groups that will be administered either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until evidence of tumor progression, unacceptable toxicity or withdrawal of consent. Tumor response will be monitored every 6 weeks by MRI until disease progression occurs.

The trial is being conducted at the John Wayne Cancer Center/Sarcoma Oncology Center in Santa Monica, Calif., City of Hope in Duarte, Calif. and the Louisiana State University Health Sciences Center in New Orleans, the company said.

The primary objective of the clinical trial is to determine progression-free survival or PFS and overall survival or OS, and the principal secondary objective is an evaluation of the safety of aldoxorubicin in the study subjects.

The Phase 2 study follows positive, confirmatory results reported earlier this year from a preclinical study in which aldoxorubicin demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals.