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CytRx Shares Plunge as Study of Key Cancer Drug Doesn't Meet Primary Endpoint; Second Analysis Planned
14 hours 26 minutes ago - DJNF
By Maria Armental
CytRx Corp. shares dropped sharply as the company said a study of a key cancer drug didn't show evidence of meeting its primary endpoint, and that it plans a second analysis of the data after many patients had to be excluded from analysis due to a partial clinical hold.
The stock plunged 64% to 90 cents in after-hours trading. Through Monday's close, the stock had fallen more than 20% in the past three months.
Los Angeles-based CytRx said the pivotal study of its key drug, aldoxorubicin, as a treatment for soft-tissue sarcoma failed to meet its primary endpoint--showing a significant difference in progression-free survival when compared to the investigator's choice therapy--but showed promising results in objective response rate and disease control rate.
Aldoxorubicin is a modified version of doxorubicin, a widely used anti-cancer drug.
The Food and Drug Administration placed CytRx's aldoxorubicin trial on partial clinical hold in 2014 following a patient's death. The patient was being treated under the company's compassionate use program.
Under a partial hold, the clinical trial continued but no new patients could enroll until the hold was lifted.
CytRx, which has yet to post a profit, said Monday that the interruption didn't allow for sufficient follow-up for the nearly two-thirds of patients enrolled, resulting in the exclusion of nearly half of the patients from the analysis.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
July 11, 2016 17:41 ET (21:41 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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