Shares of AtheroGenics/NASDAQ: AGIX dropped after the company announced it would increase enrollment for its AGI-1067’s Phase III ARISE trial to treat clogged arteries to 6,000 patients from the current 4,000 patients. The proposed change, which is subject to FDA approval, is to increase the overall statistical power of the trial.
ARISE is a multinational, double-blind, placebo-controlled trial to evaluate the effect of AGI-1067 on important clinical outcome measures including death due to cardiovascular disease, myocardial infarction, stroke, coronary-revascularization and unstable angina in patients who have coronary artery disease (CAD). The Phase III trial is designed to assess the incremental benefits of AGI-1067 over current “standard of care” therapies in this patient population. Eligible patients are being randomized to receive oral AGI-1067 or placebo, once daily, in addition to receiving other appropriate heart disease medications, which may include statins and other cholesterol-lowering therapies, high blood pressure medications and anti-clotting agents.
The company originally expected enrollment to be completed by mid-2005 and the trial to be completed in late 2005. With the proposed changes the trial would be completed in the first quarter of 2006, delaying trial results and the NDA filing. Given the increased size and longer duration of the trial, the company said it would seek approval from the FDA to eliminate the minimum 12-month follow-up period for subjects.
The ARISE study will provide important information as to whether an agent with anti-inflammatory properties can provide clinically significant reduction of mortality and morbidity when used in conjunction with current standard of care therapies in patients with CAD. While statins and other cholesterol-lowering therapies have proven to be beneficial in slowing the progression of heart disease, the anti-inflammatory properties of AGI-1067 may become a powerful complement to statin use.
If the ARISE study is successful, it would support an NDA for AGI-1067 with an indication for secondary prevention in patients with coronary heart disease. Secondary prevention for atherosclerotic cardiovascular disease is treatment that improves patient survival, reduces recurrent events such as heart attack and stroke, reduces the need for interventional procedures, and improves the quality of life for these patients.
In the mean time, AtheroGenics continues to seek a strategic partnership with a major pharmaceutical company to complete the development and commercialization of AGI-1067. Securing a partnership would be a positive trigger for AtheroGenics, which could happen when all of the CART-2 Phase II data are published or presented at a medical meeting, such as the American College of Cardiology in March 2005 when potential partners have full access to the clinical data. As we had mentioned in our January 2005 report, given the unknowns, AtheroGenics’ shares would be volatile and if there were any negative news, its share price would face a significant drop. At the stock’s current level, Wall Street has factored the risk into AtheroGenics’ stock price and the reward will outweigh the risk. AtheroGenics represents an attractive short-term stock, which should rebound with anticipated news flow from industry analysts who are interested in AGI-1027’s potential.
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