Drug Development

CytRx concedes that its only drug flunked a PhIII sarcoma test, routing shares

Three years after one of its drugs had to be scrapped following a failed study, CytRx was forced to concede that its Phase III study of its lead drug aldoxorubicin flopped against treatment resistant soft tissue sarcomas.

The company tried to put the most positive spin on it, saying that the results had been confounded by an interruption due to a temporary partial clinical hold in 2014. But the progression-free survival rate for the drug came in at 4.17 months, hardly distinguishable from the 4.04 months tracked for investigators’ choice among standard treatments.

Because of the hold, the company claimed, “this analysis did not provide for sufficient follow-up for the nearly two-thirds of patients who entered the Phase III study after the hold was resolved and enrollment resumed.” Further analysis will be done at a later point. And CytRx claimed positive results on the objective response rate and the rate of disease control. But the company also noted that the results were assessed after 191 progression events, as specified in their special protocol assessment with the FDA.

CytRx’s shares were crushed in the rout that followed, dropping 60% toward penny stock territory.

The hooting and catcalls erupted on Twitter within minutes of the post.

Aldoxorubicin is involved in 6 studies and accounts for the only drug CytRx has in the clinic, according to its web site.

The drug is a modified form of doxorubicin, a well-known and toxic chemo agent. Researchers use a linker that attaches the drug to circulating protein called albumin, which in turn is gobbled up by hungry tumors. And it’s designed to release the drug in the tumor, while staying benign in healthy tissue. This new approach is supposed to allow for higher, more effective dosing to fight the cancer.

The hold followed the death of a patient taking their drug under a compassionate use program.

Steven A. Kriegsman, CytRx

Steven A. Kriegsman, CytRx

With bad news to report, though, the Los Angeles-based company was careful to note how much cash it has in the bank, and what it can do with that money before it runs out. Ahead of the announcement, the company’s market cap sat at a small $171 million.

“In over 550 patients treated to date, aldoxorubicin has demonstrated anti-tumor activity in multiple tumor types and has shown a manageable safety profile,” said Steven A. Kriegsman, CytRx’s Chairman and CEO. “With approximately $68.2 million in cash and equivalents as of our last 10-Q filing, CytRx is funded through the next Phase III STS trial analysis and through a readout of our global Phase IIb trial of aldoxorubicin in small cell lung cancer.”

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