Study Shows Carperitide Significantly Reduces Cardiac Death and Improves Outcomes in Acute Myocardial Infarction
New Data Published in Lancet Support the Development of Carperitide as Adjunct Therapy to Percutaneous Coronary Intervention
ROCHELLE PARK, N.J., Jan. 15, 2008 (PRIME NEWSWIRE) -- According to an independent study published in the Lancet in October 2007, carperitide (human atrial natriuretic peptide) significantly reduced cardiac death and re-hospitalization for heart failure in acute myocardial infarction (AMI), when used as an adjunct to percutaneous coronary intervention (PCI). Carperitide is a compound that has been marketed for more than a decade in Japan for the treatment of acute heart failure and is available for licensing in the U.S. and Europe.
"We are extremely encouraged by the positive results of this clinical study which reproduces positive findings of smaller studies of carperitide. We believe that further development will demonstrate that carperitide can be a safe and effective adjunctive treatment for acute myocardial infarction," said Dr. Bruce Reidenberg, Senior Director, Clinical Research at Asubio.
In the independently conducted, large-scale, randomized, single-blind study by J-WIND in 603 patients, carperitide, when administered to AMI patients after reperfusion treatment, was associated with a reduction in infarct size by 14.7%, reduction in reperfusion-related injuries by 25.9%, and statistically significant reductions in cardiac-related mortality and hospitalizations due to heart failure relative to the standard of care(1). Approximately 10% of patients on carperitide experienced hypotension. These results were consistent with other smaller clinical studies where carperitide was associated with treatment benefit when administered to patients with AMI.
Carperitide is a recombinant form of human atrial natriuretic peptide, or hANP. While the major pharmacological effects of natriuretic peptides are known to be vasorelaxation and natriuresis, emerging evidence suggests that carperitide, when administered at doses that are considered to be sub-hemodynamic, may have a direct protective effect on cardiomyocytes under conditions consistent with ischemia/reperfusion-related injury in AMI.
Asubio is currently considering the licensing of this compound for further development in the U.S. and Europe. Please direct inquiries to Robert Reed, Asubio Pharmaceuticals, Inc., 201-368-5020.
Ischemic heart disease is one of the main causes of chronic heart failure, a major cause of morbidity and mortality worldwide. There are more than 850,000 new or recurrent AMIs each year in the U.S. alone(2). Ischemia/reperfusion-related sequelae occurring by discharge play a significant role in the long-term morbidity and mortality associated with AMI. Few medications however have been shown to decrease ischemia or reperfusion injury. Recent clinical studies have provided evidence that carperitide administration can significantly reduce myocardial damage after AMI. Scientific data supports further development of carperitide as adjunct therapy to PCI in the acute treatment of myocardial infarction.
About Asubio Pharmaceuticals, Inc.
Asubio Pharmaceuticals, Inc. is the U.S. subsidiary of Tokyo-based Asubio Pharma Co., Ltd, a pharmaceutical business entity that is wholly owned by Daiichi Sankyo Company, Ltd. Established in the U.S. in June 1999, Asubio focuses on the early stage clinical development of novel new chemical entities and biologics discovered by its Japanese parent. Asubio is committed to improving clinical outcomes and quality of life of people suffering from devastating CNS, cardiovascular, immunological and inflammatory conditions. Asubio is also developing other opportunistic projects that utilize the company's expertise and fill a therapeutic void in important areas of medicine.
This press release contains certain forward-looking statements about the potential of the investigational compound Carperitide and reflects Asubio's current beliefs. However, as with any pharmaceutical compound under development, there are substantial risks and uncertainties in the process of development and regulatory review. All statements, facts, information, analyses, interpretations, and opinions contained in the report are provided "As Is" and are made without representation or warranty of any kind by Asubio, or their respective parents, affiliates, officers, employees, contractors or business partners as to accuracy, completeness, usefulness, merchantability, fitness for a particular purpose, or otherwise. There is no guarantee that later studies and patient experience with Carperitide will be consistent with study findings to date. Asubio makes no guarantee, warranty, or assurances concerning the future financial return of an existing or proposed product or service related to the business alliance under evaluation. Asubio undertakes no duty to update forward-looking statements, and does not provide or act as a substitute for legal guidance and expertise.
Carperitide is under consideration for investigation for the treatment of acute myocardial infarction. It has not been approved in any country by any regulatory authority for this indication. Carperitide is approved for use in Japan for the treatment of acute heart failure since 1995.
1. Kitakaze, Masafumi et al, Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials. The Lancet 2007; 370:1483-93.
2. Heart Disease and Stroke Statistics - 2007 Update: A Report From the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circ J 2007: e89. Accessed at http://circ.ahajournals.org/cgi/content/full/115/5/e69.
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Posted: January 2008