Pexelizumab being investigated to reduce perioperative mortality in patients undergoing CABG-CPB surgery
Aug 11, 2005, 01:05, Reviewed by: Dr.
|If approved, pexelizumab would represent the first of a new class of therapeutics called terminal complement inhibitors for the reduction of death and perioperative myocardial infarction in patients undergoing CABG-CPB surgery.
Alexion Pharmaceuticals, Inc. and Procter & Gamble Pharmaceuticals (P&GP), a division of The Procter & Gamble Company, announced today the completion of enrollment for the pivotal Phase III PRIMO-CABG2 efficacy trial of pexelizumab. This agent is being investigated for reducing mortality and myocardial infarction (heart attack) following coronary artery bypass graft (CABG) surgery.
The "Pexelizumab for Reduction of Infarction and Mortality in Coronary Artery Bypass Graft surgery 2" (PRIMO-CABG2) pivotal Phase III trial is examining the effect of pexelizumab in approximately 4,250 patients undergoing CABG surgery with or without concomitant valve surgery during cardiopulmonary bypass. This study is being conducted in six countries in Europe and North America, including the United States, and results are expected by the end of 2005.
"We are pleased to announce the completion of enrollment in the PRIMO- CABG2 trial ahead of our previously announced schedule," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "The enthusiastic response of our multinational clinical investigators allowed for a rapid completion of enrollment in this large acute cardiovascular trial and we greatly appreciate the efforts of all those involved in the study."
Alexion and P&GP previously reported that they had reached agreement with the U.S. Food and Drug Administration under the special protocol assessment process on the design of the PRIMO-CABG2 study. It is expected that, if successful, this trial will form the primary basis of review for the approval of a Biological License Application for pexelizumab for the CABG indication.
Pexelizumab is an Alexion-engineered monoclonal antibody fragment designed to inhibit complement-mediated tissue damage associated with reperfusion injury and inflammation that occurs during open heart surgery. If approved, pexelizumab would represent the first of a new class of therapeutics called terminal complement inhibitors for the reduction of death and perioperative myocardial infarction in patients undergoing CABG-CPB surgery.
"If approved, pexelizumab would represent a new approach to improving outcomes for patients undergoing CABG surgery," said Mark Collar, President, P&G Global Pharmaceuticals and Personal Health. "We are pleased with the seamless execution of this pivotal program with our partner Alexion and with the opportunity to quickly advance this potential novel therapy."
Alexion and P&GP also continue to study pexelizumab in patients experiencing acute myocardial infarction (AMI) treated with primary percutaneous intervention in the pivotal Phase III APEX-AMI trial. APEX-AMI is actively enrolling patients in North America, Europe, Australia and New Zealand.
- Procter & Gamble Pharmaceuticals, Inc.
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About Alexion (Nasdq: ALXN)
Alexion is engaged in the discovery and development of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and cardiovascular disorders, autoimmune diseases and cancer. Alexion's two lead product candidates, pexelizumab and eculizumab, are currently undergoing evaluation in several clinical development programs, including two Phase III trials of eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a Phase III trial of pexelizumab in coronary artery bypass graft (CABG) surgery patients undergoing cardiopulmonary bypass (CPB), and a Phase III trial of pexelizumab in acute myocardial infarction (AMI) patients. The pexelizumab trials are conducted in collaboration with Procter and Gamble Pharmaceuticals. Under the Special Protocol Assessment process, the FDA has agreed to the design of protocols for the Phase III pexelizumab trials that could, if successful, serve as the primary basis of review for approval of licensing applications for the two indications. Also under the Special Protocol Assessment process, the FDA has agreed to the design of protocols for the two trials of eculizumab in PNH patients that could, if successful, serve as the primary basis of review for approval of a licensing application for eculizumab in the PNH indication. Eculizumab is also being studied in rheumatoid arthritis and membranous nephritis. Alexion is engaged in discovering and developing a pipeline of additional antibody therapeutics targeting severe unmet medical needs, through its wholly owned subsidiary, Alexion Antibody Technologies, Inc. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: http://www.alexionpharm.com .
P&G: All statements, other than statements of historical fact included in this release, are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. In addition to the risks and uncertainties noted in this release, there are certain factors that could cause actual results to differ materially from those anticipated by some of the statements made. These include: (1) the ability to achieve business plans, including with respect to lower income consumers and growing existing sales and volume profitably despite high levels of competitive activity, especially with respect to the product categories and geographical markets (including developing markets) in which the Company has chosen to focus; (2) the ability to successfully execute, manage and integrate key acquisitions and mergers, including (i) the Domination and Profit Transfer Agreement with Wella, and (ii) the Company's agreement to merge with The Gillette Company, including obtaining the related required shareholder and regulatory approvals; (3) the ability to manage and maintain key customer relationships; (4) the ability to maintain key manufacturing and supply sources (including sole supplier and plant manufacturing sources); (5) the ability to successfully manage regulatory, tax and legal matters (including product liability, patent, and other intellectual property matters), and to resolve pending matters within current estimates; (6) the ability to successfully implement, achieve and sustain cost improvement plans in manufacturing and overhead areas, including the Company's outsourcing projects; (7) the ability to successfully manage currency (including currency issues in volatile countries), debt (including debt related to the Company's announced plan to repurchase shares of the Company's stock), interest rate and certain commodity cost exposures; (8) the ability to manage the continued global political and/or economic uncertainty and disruptions, especially in the Company's significant geographical markets, as well as any political and/or economic uncertainty and disruptions due to terrorist activities; (9) the ability to successfully manage the pattern of sales, including the variation in sales volume within periods; (10) the ability to successfully manage competitive factors, including prices, promotional incentives and trade terms for products; (11) the ability to obtain patents and respond to technological advances attained by competitors and patents granted to competitors; (12) the ability to successfully manage increases in the prices of raw materials used to make the Company's products; (13) the ability to stay close to consumers in an era of increased media fragmentation; and (14) the ability to stay on the leading edge of innovation. For additional information concerning factors that could cause actual results to materially differ from those projected herein, please refer to our most recent 10-K, 10-Q and 8-K reports.
Alexion: This news release contains forward-looking statements, including statements regarding the timing of completion and announcement of results regarding the PRIMO-CABG2 trial. Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including the results of pre-clinical or clinical studies (including termination or delay in clinical programs), the need for additional research and testing, delays in arranging satisfactory manufacturing capability, inability to acquire funding on timely and satisfactory terms, delays in developing or adverse changes in commercial relationships, the possibility that results of earlier clinical trials are not predictive of safety and efficacy results in later clinical trials, dependence on Procter & Gamble Pharmaceuticals for development and commercialization of pexelizumab, the risk that third parties won't agree to license any necessary intellectual property to us on reasonable terms, and a variety of other risks set forth from time to time in Alexion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion's Annual Report on Form 10-K for the year ended July 31, 2004 and in our other filings with the Securities and Exchange Commission. P&GP retains the development rights and the termination rights discussed in Alexion's Form 10-K referred to above. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.
Alexion Pharmaceuticals Inc.
Leonard Bell, M.D.
Chief Executive Officer
The Procter & Gamble Company
Procter & Gamble Pharmaceuticals, Inc.
(513) 622-3923 (direct)
Patricia Garrison (Scientific Media)
Rhonda Chiger (Investors)
Emily Poe (Business and Financial Media)
CONTACT: Leonard Bell, M.D., Chief Executive Officer of AlexionPharmaceuticals Inc., +1-203-272-2596; Scientific Media - PatriciaGarrison, +1-917-322-2567, Investors - Rhonda Chiger, +1-917-322-2569, bothof Rx Communications for Alexion Pharmaceuticals; Business and FinancialMedia - Emily Poe of Noonan
Web site: http://www.pg.com/http://www.alexionpharm.com/
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