CytRx Corp., a biopharmaceutical research and development company specializing in oncology, today announced that it has initiated a Phase 2 clinical trial with the Company’s aldoxorubicin for the treatment of unresectable glioblastoma multiforme (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 clinical trial is expected to 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 primary objective of the clinical trial is to determine progression-free survival (PFS) and overall survival (OS), and the principal secondary objective is an evaluation of the safety of aldoxorubicin in the study subjects.
This 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. In that study, animals treated with aldoxorubicin had median survival of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline. In addition, because aldoxorubicin uptake was confined only to the tumor in the brain and did not enter normal brain tissue, the principal investigator concluded that aldoxorubicin has the potential to safely shrink glioblastoma tumors, which could dramatically prolong patient survival. This study was replicated by Crown Biosciences, an independent research laboratory.
“We were highly encouraged by aldoxorubicin’s apparent ability to cross the blood-brain barrier, potentially creating a new approach to attacking brain tumors. We are on track with the rapid development of aldoxorubicin for unresectable GBM, and look forward to having preliminary results from this Phase 2 trial in 2014,” stated CytRx President and CEO Steven A. Kriegsman. “Should the data from this trial be positive, we plan to file for breakthrough therapy designation with the U.S. Food and Drug Administration, which could expedite marketing approval."
Dr. Brian Boulmay of the LSU Health Sciences Center and the principal investigator in the study commented, “Patients with unresectable GBM who have failed prior surgery, radiation and chemotherapy have an extremely poor prognosis, with progression-free survival of around 16 weeks and median overall survival of approximately 31 weeks following treatment. Our Phase 2 study will provide important data on aldoxorubicin’s potential to effectively treat these patients.”
For more information, visit www.cytrx.com
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