 
|
  |
  |
  |
 
|
  |
  |
| KAI to Present KAI-9803 Phase I/II Trial Data in a Late-Breaking Session of the ACC |
|
February 7, 2007
KAI Pharmaceuticals to Present KAI-9803 Phase I/II Trial Data in a Late-Breaking Session of the American College of Cardiology, March 25, 2007 South San Francisco, CA – February 7, 2007 – KAI Pharmaceuticals, Inc., a privately held biotechnology company, today announced that it will unveil the results of its Phase I/II trial of KAI-9803 (DELTA-MI) in a Late-Breaking Session of the 56th Annual Scientific Session of the American College of Cardiology (ACC), March 25, 2007 at 11:30 a.m. in New Orleans at the i-2 Intervention Summit. Dr. Matthew Roe from the Duke Clinical Research Institute in Durham, North Carolina, the study’s principal investigator, will present the results of the 154-patient trial, which was completed in November, 2006. “Given the ACC’s focus this year on earlier stage novel therapies for cardiovascular disease, we are excited to participate in this important conference,” said Steven James, president and chief executive officer of KAI. “No treatments addressing reperfusion injury are on the market today, making KAI-9803 potentially a first-in-class agent and breakthrough therapeutic approach for AMI.” DELTA-MI was a randomized, double-blind, placebo-controlled study evaluating increasing doses of KAI-9803 as a treatment for ameliorating reperfusion injury associated with heart attacks, or acute myocardial infarction (AMI). Reperfusion injury is a major cause of inflammation and damage to the heart that occurs after restoring flow to the occluded coronary artery with either angioplasty/stenting or thrombolytic medications. In DELTA-MI, KAI-9803 was delivered locally through the balloon catheter in patients undergoing angioplasty as a treatment for their heart attack. “In the DELTA MI trial, we assessed a large number of simultaneous biomarkers of myocardial function and perfusion, as well as safety and clinical events, to comprehensively characterize the impact of KAI-9803 in patients experiencing a heart attack,” according to Dr. Roe. “We believe this in-depth characterization of such a first-in-class reperfusion injury agent is critical to speed the development and testing of novel adjunctive therapies for the treatment of heart attacks.” Separately, KAI announced it will reacquire the exclusive worldwide rights to develop and commercialize KAI-9803 from Daiichi Sankyo Company, Limited. KAI and Daiichi Sankyo entered into a collaboration agreement in December 2005 for the global development and commercialization of KAI-9803, with an initial focus on cardiovascular disease. “"We recently concluded, following a full global review, that KAI-9803 would not be a priority compound within the merged Daiichi Sankyo pipeline, and a decision was made to return development rights to KAI," said John Alexander, MD, President of DAIICHI SANKYO Pharma Development, "We have high regard for KAI's novel platform and its research capabilities, and wish KAI success with their continued development of KAI-9803." About KAI-9803 KAI-9803 is an isozyme-selective delta protein kinase C (δPKC) inhibitor designed to reduce ischemia and reperfusion injury during treatment of AMI. KAI-9803 has received a Fast Track designation from the FDA for this indication. Reperfusion injury occurs when myocardial and endothelial cells undergo necrosis and apoptosis after the reintroduction of blood flow to the ischemic areas following heart attack. Apoptosis is the process whereby cells autodestruct after exposure to certain noxious stimuli. Selective inhibition of the δPKC isozyme by KAI-9803 prevents damage to the mitochondria and inhibits both necrosis and apoptosis during reperfusion injury. In preclinical studies, treatment with KAI-9803 resulted in a significant reduction in infarct size and improvement in heart function. About KAI Pharmaceuticals KAI Pharmaceuticals is a privately held, venture-backed drug discovery and development company with preclinical and clinical programs in acute cardiovascular and other diseases representing unmet medical needs. The company has applied its core expertise in the biology of protein kinase C (PKC) to develop highly potent and selective inhibitors and activators for each of the PKC isozymes for the treatment of a broad array of human diseases. KAI is based in South San Francisco, California, and can be found online at www.kaipharma.com.
|