I suppose ivus scans are quite complicated and apparently cumbersome to measure. I wouldn't know what renders a scan unreadable. I guess we'll have to see what the final cart II data show to see if they cherry picked in this interim analysis.
I think the bottom line for agix is the arise-events trial will be the new binary event and a HUGE one at that. Unless they agree to merge in the interim. Arise aftermath (up or down) will make cart II action seem insignificant.
[If anything, Topol’s remarks reported today by Reuters are even harsher, in a professional sense, than what appeared in Barron’s (#msg-4186873). (FWIW: my own views on this trial are summarized in #msg-4197838.)]
NEW YORK, Oct 4 (Reuters) - AtheroGenics Inc. (AGIX) inappropriately used the name of a leading hospital to put a positive spin on a trial of its heart drug, the head of cardiovascular medicine at the hospital said on Monday.
Dr. Eric Topol of the Cleveland Clinic Foundation said the reliability of the company's clinical trial of a drug to help prevent heart disease was far from clear because the main goal of the trial was changed once it had begun.
"I feel very uncomfortable that the company has announced its positive results and used the Cleveland Clinic's name as supportive of them when the data are not at all conclusive or even in my mind suggestive because of all these irregularities," he said.
Topol first aired his views in Barron's at the weekend, sending its stock down 10 percent on Monday. It later recovered, closing up 4.8 percent at $34.50 on Nasdaq.
AtheroGenics on Monday took issue with Topol's assessment.
"We reported results of data that were analyzed by the Cleveland Clinic and we stand by the validity of those data," Mark Colonnese, chief financial officer of AtheroGenics, said in an interview late on Monday.
Last week AtheroGenics released interim results from a small, mid-stage clinical trial showing its drug, AGI-1067, reduced plaque in coronary arteries by an average of 3.8 percent, a magnitude of reduction not seen in any existing therapies. The buildup of plaque can cause arteries to block, often leading to heart attacks.
Data from the trial was originally analyzed at the Montreal Heart Institute. But AtheroGenics, based in Atlanta, was dissatisfied with the results and asked the Cleveland Clinic to reanalyze the data, according to the clinic.
"They said they were concerned about the reliability of the initial analysis," said Dr. Steven Nissen, whose laboratory headed the reanalysis at Cleveland.
Dr. Jean-Claude Tardif, who led the study in Montreal, did not return Reuters calls seeking comment. AtheroGenics did not specify the problems with the Montreal analysis.
Topol said the results of a secondary analysis should not have been used by the company to support results that should have come from Montreal. He said AtheroGenics took the Cleveland results back to Montreal, where a new analysis was performed that produced results more in line with those from Cleveland.
"Whenever you redesign a trial and bring in a second analysis group, it reduces the confidence and reliability of the results," Nissen said.
Even so, many remain optimistic.
"We still believe the data presents the strongest case to date in the drug's ability to cause plaque regression," said Joseph Pantginis, an analyst at JB Hanauer & Co.
Robin Levin, an analyst at consultancy Cheirologic Partners, said that while people have a right to be concerned about the design of the trial, the science has "enormous merit." <<
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