KAI Pharmaceuticals Initiates Phase 2b Clinical Study of KAI-9803 in Heart Attack Patients

South San Francisco, CA – December 17, 2008 – KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, announced today the enrollment of the first patient in the Company’s Phase 2b efficacy study of KAI-9803, KAI’s proprietary, first-in-class inhibitor of the delta protein kinase C pathway (delta PKC). 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). KAI-9803 is conducting the Phase 2b trial which is being funded by Bristol-Myers Squibb Company (NYSE: BMY) under a global development and commercialization collaboration.

KAI’s President and CEO, Steven James, commented, “The achievement of this milestone is the result of a productive and highly collaborative relationship with Bristol-Myers Squibb. The company is a great partner for us, and we are delighted by the progress of our joint program.”

KAI’s Phase 2b study is a randomized, placebo-controlled, single-dose, parallel group, multinational trial that is expected to enroll 1,058 patients with STEMI undergoing PCI. Patients with STEMI will be assigned randomly to receive one of three doses of KAI-9803 or placebo by IV infusion prior to beginning PCI. The primary efficacy endpoint is infarct size and key secondary measures include assessments of microvascular perfusion and cardiac function, as well as safety.

The study is being coordinated by the Cleveland Clinic Coordinating Center for Clinical Research and the principal investigator is A. Michael Lincoff, M.D.

About KAI-9803
KAI-9803 is an isozyme-selective inhibitor of the delta protein kinase C pathway designed to reduce the size of the heart attack and to improve clinical outcomes during treatment of acute myocardial infarction (AMI). During a heart attack, blood flow to the heart is compromised resulting in myocardial and endothelial cell necrosis and apoptosis. 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. KAI-9803 has received Fast Track designation from the FDA for this indication.

In KAI’s phase 1/2 study (DELTA-MI) in patients undergoing PCI to treat STEMI, patients receiving KAI-9803 experienced less damage to heart muscle compared to patients receiving a placebo. Favorable measures of cardiac biomarkers including reduced infarct size and improved microvascular perfusion were observed.

About KAI Pharmaceuticals
KAI is a drug discovery and development company with multiple, novel clinical-stage programs in cardiovascular disease and pain. KAI’s lead product candidate, KAI-9803, is partnered with Bristol-Myers Squibb and has demonstrated efficacy in reducing damage to heart and improving cardiac function in MI patients undergoing balloon angioplasty. KAI’s second clinical program, KAI-1678, is a promising, first-in-class drug candidate that may address both the inflammatory and neuropathic pain markets.

KAI’s expertise is in the selective modulation of intracellular protein:protein interactions and delivery of peptides into the cell. This approach has broad potential and has been validated clinically. The Company has applied its core expertise to discover highly potent and selective inhibitors and activators for validated PKC protein kinase C (PKC) isozymes. KAI is based in South San Francisco, California, and can be found online at www.kaipharma.com .