FDA Places Hold On Cancer Drug Trial After Patient Dies

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.

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.

Were You or Someone You Know Injured by a Defective Drug?

Unfortunately, people are injured by harmful drug side effects every day. We have such stringent constraints on the drug industry in the U.S. that it is easy to falsely trust a drug, simply because it has been approved by the FDA. However, there are drug manufacturers with less than scrupulous intentions who may mislead the FDA or withhold information from the public about possible dangerous side effects that can cause serious injury or even death.

Makers of dangerous or defective drugs can be held responsible for the injuries they cause. Our law firm holds these drug manufacturers responsible and we fight diligently to recover damages for our clients. Our defective drug attorneys work on a contingency, so you don’t pay any legal fees until we win money for you. Get a free consultation today from an experienced drug side effects attorney at Handler Henning and Rosenberg today.

Remember, we have offices throughout Pennsylvania to handle any drug injury case. If you cannot come to us, we will come to you in your home or the hospital. Get your free consultation today and get the compensation you deserve.


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