Clinical Trials of Aldoxorubicin on Hold After Death of Patient
The FDA recently placed a partial hold on clinical trials for the cancer treatment drug aldoxorubicin, after the death of one of their test subjects. The company holding the trials is CytRX, a cancer drug maker based in Los Angeles, CA. CytRx contends that the patient who died was not qualified to participate in the study, as they had an advanced-stage cancer. This patient was receiving treatment under an expanded access program.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Source: U.S. National Library of Medicine. http://www.nlm.nih.gov/services/ctexpaccess.html
What Is a Partial Hold?
In this case, the FDA is not allowing any new patients to be enrolled in the trials until the hold is removed. Any patients currently receiving the new drug will continue to receive treatments with aldoxorubicin. The drug maker is expected to amend their trial study protocols to specify criteria for patient inclusion/exclusion.
How does Aldoxorubicin Work?
The drug operates by combining a chemotherapeutic agent with a binder consisting of a single molecule. The Chemo agent is doxorubicin, and it binds to albumin, which is the highest concentration of protein in the blood stream.
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