CytRx says FDA to decide on study enrollments in January (updated)

LadRx

06/01/2015 20:52

* Interim data shows drug stops tumor progression 
    * Drug could be first to cross blood-brain barrier - CEO 
    * Shares jumps as much as 30 pct 
 
 (Adds CEO comments, updates shares) 
    By Rosmi Shaji and Vidya L Nathan 
    Jan 6 (Reuters) - CytRx Corp  CYTR.O  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.  ID:nL3N0T84DB  
    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.  ID:nPn7J7x8f  
    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) 
 ((Rosmi.Shaji@thomsonreuters.com; Within U.S.+1 646 223 8780 
and outside U.S. +91 8067496753; Reuters Messaging: 
rosmi.shaji.thomsonreuters.com@reuters.net)) 
 
Keywords: CYTRX STUDY/