FDA Puts Partial Hold on CytRx Cancer Drug Trials (Aldoxorubicin)

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 By Reuters Staff

November 19, 2014

(Reuters) - CytRx Corp said the U.S. Food and Drug Administration placed a hold on enrolling new patients in clinical trials of its experimental cancer drug after a patient died, sending the company's shares down 11% in premarket trading.
The patient received the drug, aldoxorubicin, under the company's expanded access program that makes promising drugs and devices available to patients with serious diseases who do not qualify for the trials.
Patients already enrolled in the trials, currently in mid stage, will continue receiving the treatment, CytRx said.
The company said it would change its inclusion and exclusion criteria for new patients and add additional patient screening assessment, at the request of the FDA.
Aldoxorubicin is an improved version of the chemotherapy agent, doxorubicin, and it does not cause the side effects associated with doxorubicin such as heart muscle damage at higher doses and gastrointestinal disorders.
This means aldoxorubicin can be administered in higher doses than doxorubicin.
Aldoxorubicin is being tested for treating soft tissue sarcoma, small cell lung cancer, pancreatic cancer and a type of brain tumor.