KAI’s lead product candidate, KAI-9803, is an isozyme-selective delta protein kinase C (δPKC) inhibitor designed to reduce ischemia and reperfusion injury as an adjunct to current treatments for acute myocardial infarction (AMI, commonly referred to as heart attack). KAI is currently enrolling patients in a phase 2b efficacy trial. KAI-9803 has received a Fast Track designation from the FDA. 

During a heart attack, blood flow to the heart is compromised resulting in death of myocardial tissue. Selective inhibition of the delta PKC isozyme by KAI-9803 may reduce the injury to myocardial and endothelial cells during a heart attack and reduce the risk of death or heart failure.

The Phase 2b trial (PROTECTION AMI) is designed to assess the effect of KAI-9803 on reducing myocardial injury in patients with ST segment elevation myocardial infarction (STEMI) who are undergoing percutaneous coronary intervention (PCI). Additional information on the PROTECTION AMI trial can be found at www.clinicaltrials.gov . In KAI’s Phase 1/2 study (DELTA-MI) in patients undergoing PCI to treat STEMI, patients who received KAI-9803 experienced less damage to heart muscle compared to patients who received a placebo. Further, KAI’s Phase 1/2 study showed favorable measures of cardiac health, including reduced infarct size and improved microvascular perfusion.

In May 2008, KAI announced an exclusive collaboration with Bristol-Myers Squibb (BMS) for the global development and commercialization of KAI-9803. Under the agreement, KAI is conducting a Phase 2b study funded by BMS and may receive up to $192 million in milestone payments, based on the achievement of pre-specified development and regulatory milestones. Further, KAI received from BMS an upfront cash payment of $25 million. At KAI’s option, Bristol-Myers Squibb will purchase $10 million of KAI stock at the time of a qualified initial public offering or under other specified future conditions.

AMI Market Overview
Cardiovascular disease is the leading cause of death, with approximately 1.2 million cases of AMI in the United States each year.¹ Despite recent advances in the treatment of AMI such as thrombolytic therapy and angioplasty, morbidity and mortality associated with AMI remains high. Up to 25% of men and 38% of women die within one year of suffering from an initial AMI.¹ Within six years of an AMI, 18% of men and 35% of women suffer from a second MI and 22% of men and 46% of women are disabled with heart failure.¹

¹ Source:  AHA, ASA Heart Disease and Stroke Statistics – 2005 update