Drug Maker’s Stock Falls After Death of Patient

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CytRx Corp. knew it was taking a risk when it began offering its main experimental oncology drug to a late-stage cancer patient who had not qualified for clinical trials.

That risk turned into a setback for the company last week when the Brentwood biotechnology firm announced the patient had died and that the Federal Drug Administration would be placing a hold on enrolling patients in trials for the drug, called aldoxorubicin.

The news caused CytRx shares to fall 6 percent to close at $2.63 for the week ended Nov. 19. (See page 51.)

Kay Holcombe, a senior vice president at the Washington, D.C., Biotechnology Industry Organization, said companies such as CytRx are aware of the risk they’re taking when participating in so-called expanded access programs, which offer experimental drugs to patients outside of clinical trials. The hope is to help a sick patient with few other options, but the negative fallout can be severe if a patient dies.

“It is a big risk for companies to do that,” said Holcombe. “They have to consider the benefit-risk equation.”

CytRx is conducting phase 2 clinical trials for the drug among patients with a form of brain cancer and also tumors of the connective tissue related to HIV. Patients enrolled in those trials will continue to receive the drug. Aldoxorubicin combines established chemotherapy drug doxorubicin with a molecule that enables higher levels of doxorubicin to be safely given to patients without endangering healthy tissue.

Expanded access trials differ from clinical trials in a few ways and the drug is not necessarily administered as part of the same protocol. There are a variety of reasons a patient might not qualify for a clinical trial, including age and condition. Expanded access can only take place with the FDA’s approval.

It has recently become a hot issue. Five states have passed “right-to-try” laws this year that allow terminally ill patients to receive experimental drugs, seeking to expedite terminally ill patients’ access to the drugs.

CytRx said in a statement that it is taking the advice of the FDA and changing its criteria for including or excluding new patients in its studies. It is also doing additional screening of patients.

The company said that it expects to release preliminary results from its ongoing trials in the first half of next year and that the time lines for those trials will not be materially changed by the events of last week.

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