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Biotech / Medical : AtheroGenics, Inc.{AGIX}-nasdaq -- Ignore unavailable to you. Want to Upgrade?


To: Clarksterh who wrote (317)11/4/2007 11:46:43 PM
From: mlrb2113  Respond to of 332
 
O.T.
I see where our ol' friend the most honorable Mr. Marc Wohlbier (always just one of the boys, I might add),

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Yahoo! ID: marc_wohlbier Real Name: Robert Rubin,

is now the exalted ruler of Citigroup



To: Clarksterh who wrote (317)11/9/2007 6:21:36 PM
From: mlrb2113  Respond to of 332
 
THANK YOU MR. CLARK!
Trial Discontinuing Highest Dose of AGI-1067
ANDES to Continue With Two Lower Doses

ATLANTA, GA--(Marketwire - November 09, 2007) - AtheroGenics, Inc. (NASDAQ: AGIX), today announced that after discussions with the U.S. Food and Drug Administration (FDA), the 300 mg dose of AGI-1067 in the ANDES trial will be discontinued based on a further review of the overall risk/benefit profile observed in the ARISE clinical trial. The ANDES trial will continue with the 75 mg and 150 mg doses. ANDES is a dose ranging study to confirm the important pre-specified diabetes findings from the Company's recently completed ARISE Phase lll clinical trial.

"We believe that AGI-1067, at the doses now being studied in ANDES, continues to represent an important opportunity as a novel treatment for patients with diabetes and heart disease," said Russell M. Medford, M.D., Ph.D., President and Chief Executive Officer of AtheroGenics. "AtheroGenics remains focused on completing ANDES enrollment by year end."

The action taken today was based on a further review of the rare occurrence of adverse effects on the liver with the 300 mg dose of AGI-1067 seen in the ARISE trial and additional discussion with the FDA about these data.



To: Clarksterh who wrote (317)11/10/2007 2:47:32 PM
From: mlrb2113  Read Replies (1) | Respond to of 332
 
I think we might've underestimated the FDA. It's unusual for it to effectively stop a trial because of a safety issue, isn't it?