CytRx says FDA to decide on study enrollments in January

By Rosmi Shaji and Vidya L Nathan

By Rosmi Shaji and Vidya L Nathan

(Reuters) - CytRx Corp said interim data showed its experimental brain cancer drug was effective in a mid-stage study and a partial clinical hold on enrollment could be lifted this month.

The U.S. Food and Drug Administration had put a partial hold on enrollment in studies of the drug, aldoxorubicin, after the death of a patient who received the drug through a compassionate use program.

The company has provided the FDA with a package of information and expects to hear back from the agency later this month, CytRx Chief Executive Steven Kriegsman told Reuters.

"...We've supplied the FDA with a very very substantial response to any question they might have. So in light of that, the feeling here is positive.... We are cautiously optimistic," Kriegsman said.

The company said in a statement that interim data showed that aldoxorubicin prevented the progression of a kind of brain tumor and even shrunk them.

The drug was tested on patients with glioblastoma multiforme (GBM) as a second-line treatment. GBM is the most deadly form of brain cancer and affects more than 12,000 people in the United States annually.

"Aldoxorubicin appears to be the first anthracycline to cross the blood-brain barrier in GBM, potentially creating a new approach to attacking brain tumors," Kriegsman said in a statement.

The blood-brain barrier is a layer of membranes that prevent toxins and other substances from passing from the blood stream into tissue. Drug developers have faced challenges in making a treatment capable of crossing this barrier to reach cancer cells.

Aldoxorubicin is also being tested to treat patients with other forms of cancer such as soft tissue sarcoma, small cell lung cancer and pancreatic cancer.

Kriegsman, who majored in journalism at the New York University, expects to launch the drug as a second-line treatment for soft tissue sarcoma in 2017, if the FDA lifts the partial hold on the company's studies.

CytRx shares touched a high of $3.72 on the Nasdaq on Tuesday, boosting its market value by nearly $50 million to about $207 million. The stock was up 18 percent at $3.36 in the afternoon.

(Editing by Savio D'Souza and Don Sebastian)