CytRx just announced substantial progress in its therapeutic agent aldoxorubicin’s phase 2 clinical trial for treatment of unresectable glioblastoma multiforme (GBM), a lethal variant of brain cancer. The first patient in the trial has been dosed with aldoxorubicin in the open-label, multisite trial, which has been designed to investigate the preliminary safety and efficacy of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation, and temozolomide.
“With the dosing of the first patients we are on schedule with this important Phase 2 GBM trial, and look forward to reporting preliminary results in the second half of this year,” said CytRx President and CEO Steven A. Kriegsman. “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 tumors. Should the data from this trial be positive, we will pursue the rapid development of aldoxorubicin for unresectable GBM, including filing for ‘breakthrough therapy’ designation with the U.S. Food and Drug Administration, which could expedite marketing approval.”
The trial is taking place at three locations: the John Wayne Cancer Center/Sarcoma Oncology Center in Santa Monica, the city of Hope in Duarte, California, and the Louisiana State University Health Sciences Center in New Orleans.
According to RANO Working Group Criteria, the purpose of the study is to determine progression-free survival and overall survival. Its primary secondary objective is to evaluate aldoxorubicin’s safety in the study’s participants, as exhibited by the frequency and severity of adverse medical events. Expected to enroll up to 28 patients, the study will have its participants randomly assigned equally to receive either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) of aldoxorubicin intravenously on Day 1; then this process will be repeated daily for another 21 days until evidence of tumor progression or abnormal toxicity become present or withdrawal consent is posted.
In 2013, the drug was found to be an effective treatment for swiftly progressing human brain cancer in the brains of animals. In that preclinical trial, animals treated with aldoxorubicin had a median survival of more than 63 days, compared with a median survival of 25 days for animals treated with doxorubicin or saline. Also, the lead investigator in that study found that aldoxorubicin could potentially safely shrink glioblastoma tumors, drastically increasing medical opportunities for a patient to survive, as the drug had remained confined to the tumor tissue as opposed to normal brain tissue.
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