Biotech Values

[DewDiligence]

AGIX attempts to tweak pivotal trial:

[No doubt there will be a range of opinions on the changes described here. In my view, when a company requests the FDA to alter the terms of an SPA, it’s not a good sign.]

http://biz.yahoo.com/prnews/050103/sfm053_1.html

AtheroGenics Provides Update on AGI-1067 Clinical Program

ATLANTA, Jan. 3 /PRNewswire-FirstCall/ -- AtheroGenics, Inc. (Nasdaq: AGIX - News), a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today provided an update on its AGI-1067 clinical program for the treatment of atherosclerosis in patients with coronary artery disease. The drug is currently being tested in a pivotal Phase III clinical trial, called ARISE, at leading cardiovascular research centers throughout the United States, Canada, the United Kingdom and South Africa.

AtheroGenics has submitted to the U.S. Food and Drug Administration (FDA) proposed amendments to the ARISE clinical trial protocol designed to enhance the trial as well as to accelerate the current pace of the trial. Subject to approval by the FDA in a manner that would not adversely affect the Special Protocol Assessment for AGI-1067, AtheroGenics intends to increase patient enrollment in ARISE to a target of 6,000 patients from the current target of 4,000 patients, thus providing an estimated fifty percent increase to 10,000 patient-years of exposure during the course of the trial. At the current rate of enrollment, the company estimates that the trial would achieve full patient enrollment by mid-2005. Given the increased size and longer duration of the trial, the Company has also proposed to eliminate the minimum 12 month follow-up period for subjects.

In addition, AtheroGenics has proposed a decrease in the target number of clinical events from 1,160 to approximately 1,000. This revised target number will continue to yield greater than 95 percent statistical power to detect a 20 percent difference in clinical events between the study arms. AtheroGenics expects that, with the above changes, the trial should be completed by the end of the first quarter of 2006. AtheroGenics plans to file a New Drug Application (NDA) with the FDA as soon as possible after the trial is completed and results are analyzed.

"We believe that these proposed changes will greatly enhance the overall quality of the ARISE Study by increasing the size and power of the safety database" said Rob Scott, M.D., Senior Vice President of Clinical Development and Regulatory Affairs and Chief Medical Officer at AtheroGenics. "In addition, the statistical power of the efficacy database of 1,000 events remains superior when compared to other contemporary studies sponsored by the largest pharmaceutical companies."

Regarding partnership activities, AtheroGenics' plan continues to be to enter into a strategic partnership with a major pharmaceutical company to complete the development and commercialization of AGI-1067. Consistent with previous statements, the Company's strategy remains focused on the quality and not the timing of a partnership. As part of this process, AtheroGenics is reviewing with prospective partners the previously announced results of the CART-2 clinical trial and the progress in the ARISE clinical trial. Additionally, a complete publication of the results of the CART-2 study, including a full analysis of efficacy and safety data, is expected later this year.
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