CytRx has dosed first patient in its open-label, multisite Phase II clinical trial with aldoxorubicin to treat unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer.
The trial is designed to evaluate the preliminary efficacy and safety of aldoxorubicin in patients whose tumours have progressed following prior treatment with surgery, radiation and temozolomide.
CytRx president and CEO Steven Kriegsman said with the dosing of the first patients the company is on schedule.
"Aldoxorubicin has been shown to have the unique ability to cross the blood-brain barrier in animal models of human glioblastoma, potentially creating a new approach to attacking brain tumours," Kriegsman said.
Preliminary results of the trial are expected to be released in the second half of 2014 and if they are positive, the company intends to pursue the development of aldoxorubicin for unresectable GBM, including filing for breakthrough therapy designation with the US Food and Drug Administration, which will help in speeding up the marketing approval.
In the trial, primary objective is to determine progression-free survival (PFS) and overall survival (OS), while the principal secondary objective is to assess the safety of aldoxorubicin in trial patients as evaluated by the frequency and severity of adverse events.
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About 28 patients will be enrolled in the trial and will be randomly assigned equally to receive either 350mg/m2 (260mg/m2 doxorubicin equivalent) or 250mg/m2 (185 mg/m2 doxorubicin equivalent) of aldoxorubicin intravenously on day one, and every 21 days thereafter until evidence of tumour progression, unacceptable toxicity or withdrawal of consent.
The trial is being carried out at the John Wayne Cancer Center/Sarcoma Oncology Center in Santa Monica, California, City of Hope in Duarte, California and the Louisiana State University Health Sciences Center in New Orleans.
Image: Coronal MRI with contrast of a glioblastoma WHO grade IV in a 15-year-old male. Photo: courtesy of Christaras A.