Navigation Links
AtheroGenics Reports ARISE Trial Results for AGI-1067

Full Study Results to Be Presented at the American College of Cardiology's Scientific Session

WIRE) -- 03/19/2007 -- AtheroGenics, Inc. (NASDAQ: AGIX) today announced that its ARISE Phase III clinical study of its lead drug candidate, AGI-1067, did not show a difference from placebo in its composite primary endpoint; however, it did achieve a number of other important predefined endpoints. These endpoints included a reduction in the composite of "hard" atherosclerotic clinical endpoints, composed of cardiovascular death, myocardial infarction (heart attack) and stroke, as well as an improvement in several key diabetes parameters, including glycemic control.

A full description of the ARISE study results will be presented by the ARISE principal investigators, Jean-Claude Tardif, M.D., Director of Research; Professor of Medicine, Montreal Heart Institute; and Marc Pfeffer, M.D., Ph.D., Professor of Medicine, Harvard Medical School; Senior Physician in Cardiology at Brigham and Women's Hospital, at the Late Breaking Clinical Trials session (Room Hall A) at the American College of Cardiology (ACC) Scientific Session in New Orleans on Tuesday, March 27 at 9:35 a.m. CDT.

While the company is disappointed that the composite primary endpoint was not met, it is encouraged by the positive results demonstrated in a number of disease states. As a result of the review of this data, the company has determined that the further development of AGI-1067 is important and the company currently intends to continue to pursue opportunities for development. The company will continue to review the data of the clinical study to prepare for discussions with the FDA to evaluate development paths forward for the drug.

A preliminary analysis of the safety data indicated th at the most common adverse event was diarrhea-related and there was an observed increase in liver function tests in some patients compared to those on standard of care.


The ARISE (Aggressive Reduction of Inflammation Stops Events) trial is a Phase III, double-blind, placebo-controlled trial in over 6100 patients with a recent acute coronary syndrome (ACS). The trial was conducted in 259 cardiac centers in the United States, United Kingdom, Canada and South Africa. The primary endpoint in the ARISE study was to compare the effect of AGI-1067 to placebo on the time to first incidence of a composite of major adverse cardiovascular events (MACE), specifically cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, need for coronary revascularization and admission to hospital for unstable angina.

About AtheroGenics, Inc. / AstraZeneca Collaboration

AtheroGenics and AstraZeneca have a worldwide collaboration covering the development and commercialization of AGI-1067. After completion of the final analysis, under the terms of the license and collaboration agreement, AstraZeneca has a 45-day period in which to decide whether or not to continue with the collaboration.

About AtheroGenics

AtheroGenics is focused on the discovery, development and commercialization of novel drugs for the treatment of chronic inflammatory diseases, including heart disease (atherosclerosis), rheumatoid arthritis and asthma. In addition to AGI-1067, the Company has another clinical-stage development program studying AGI-1096, a novel, oral agent in Phase I that is being developed for the prevention of organ transplant rejection in collaboration with Astellas. AtheroGenics also has preclinic al programs in rheumatoid arthritis and asthma utilizing its proprietary vascular protectant® technology. For more information about AtheroGenics, please visit

Disclosure Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve significant risks and uncertainties, including preliminary summary statements relating to the analysis of AtheroGenics' ARISE study for AGI-1067 and preliminary summary statements relating to the potential efficacy and safety profile of AGI-1067. These and other statements contained in this press release that relate to events or developments that we expect or anticipate will occur in the future are deemed to be forward-looking statements, and can be identified by words such as "believes," "intends," "expects" and similar expressions. Such statements are subject to certain factors, risks and uncertainties that may cause actual results, events and performances to differ materially from those referred to in such statements. AtheroGenics cautions investors not to place undue reliance on the forward-looking statements contained in this release. The preliminary results discussed in this release may not be confirmed upon full analysis of the detailed results of the ARISE study and additional information relating to the safety, efficacy or tolerability of AGI-1067, may be discovered upon further analysis of trial data. In addition, our forward-looking statements are subject to a number of factors that could cause actual outcomes to differ materially from those expressed or implied in our forward-looking statements, including that the Food and Drug Administration might not allow us to conduct further studies of the efficacy of AGI-1067 for the same or new endpoints, and, to the extent approved, additional clinical trial wo rk may take a significant period of time to complete or require significant additional resources to complete, or that AstraZeneca could terminate its collaboration agreement with us based on the results of the clinical trial. We cannot ensure that AGI-1067 will ever be approved or be proven safe and effective for use in humans. These and other risks are discussed in AtheroGenics' Securities and Exchange Commission filings, including, but not limited to, the risks discussed in AtheroGenics' Annual Report on Form 10-K for the fiscal year ended December 31, 2006. The risk factors regarding AtheroGenics that are included under the caption "Risk Factors" in AtheroGenics' Annual Report on Form 10-K for the fiscal year ended December 31, 2006 are specifically incorporated by reference into this press release. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

AtheroGenics, Inc.

Mark P. Colonnese

Chief Financial Officer


Email Contact

Media Inquiries

Jayme Maniatis

Schwartz Communications, Inc.

781-684-0770 ext. 6610

Email Contact

Investor Inquiries

Lilian Stern

Stern Investor Relations, Inc.


Email Contact


Related medicine technology :

1. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
2. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
3. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
4. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
5. Cytokinetics Reports Additional Clinical Trials Data for Ispinesib
6. The European Myeloma Platform Reports New Survival data for Revlimid Presented at the International Myeloma Workshop in Greece
7. Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection
8. Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension
9. Columbia Laboratories Reports Positive Results from Multi-dose Pharmacokinetic Study of Vaginally-administered Lidocaine
10. CytRx Reports Promising Data from Its Open-Label Extension Clinical Trial of Arimoclomol in ALS
11. Affymax Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide for the Treatment of Anemia
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 ... Juntendo universitetssjukhus ser potential att använda ... magnetresonansbilder (MR-bilder) för patienter med multipel ... ett forskningsavtal med SyntheticMR AB för att ... forskningsprojekt på sjukhuset. Med SyMRI kan man ...
(Date:11/26/2015)... PUNE, India , November 26, ... --> --> ... Research Report" and "Investigation Report on ... 2019 and 2021 forecasts data and ... library. . ...
(Date:11/26/2015)... 2015 ) ... "Radioimmunoassay Market by Type (Reagents & Kits, ... Clinical Diagnostic Labs), Application (Research, Clinical Diagnostics), ... report to their offering. --> ... of the "Radioimmunoassay Market by Type ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... ... toilets were," said an inventor from Hillside, N.J. "Many people catch diseases simply ... so that individuals will always be protected from germs." , He developed the ...
(Date:11/27/2015)... ... November 27, 2015 , ... Consistent ... sharing, the 2016 Building Better Radiology Marketing Programs meeting will showcase ... Sunday, March 6, 2016, at Caesars Palace in Las Vegas with a pre-conference ...
(Date:11/27/2015)... ... November 27, 2015 , ... CBD College is proud to announce ... (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography program. CBD College is honored to ... of twelve colleges and universities in the state of California make the cut. CBD ...
(Date:11/26/2015)... MI (PRWEB) , ... November 26, 2015 , ... ... for substance abuse located in central Michigan, have come together on Thanksgiving Day ... specially produced video, available for viewing on the Serenity Point YouTube channel, patients ...
(Date:11/26/2015)... ... November 26, 2015 , ... Jobs in hospital medical laboratories ... and offered by healthcare staffing agency Aureus Medical Group . These ... October 2015 among those searching for healthcare jobs through the company’s website, ...
Breaking Medicine News(10 mins):