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March 25, 2007
KAI Pharmaceuticals Presents Promising Phase 1/2 Results for KAI-9803 in Reperfusion Injury
Kai Pharmaceuticals is developing drugs based on protein kinase C, an important disease target. Their first program addresses cardiac ischemia reperfusion injury, a clinical problem with "holy grail" status in cardiovascular medicine. Below, Kai presents encouraging phase 1/2 results of its lead product, KAI-9803.
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KAI Pharmaceuticals, Inc., a privately held biotechnology
company, today announced that a Phase 1/2 trial evaluating
KAI-9803 for reperfusion injury showed early indications
that it may reduce damage to the heart and improve cardiac
function in heart attack patients undergoing treatment
with balloon angioplasty. The trial also showed that KAI-9803
demonstrated a favorable safety profile.
The DELTA-MI trial, an exploratory, first-in-human study,
found that patients receiving intracoronary injections
of KAI-9803 experienced less damage to the heart muscle
compared with those patients receiving a placebo. Conducted
by the Duke Clinical Research Institute (DCRI) in Durham,
N.C., the trial evaluated KAI-9803 in 154 patients who
suffered from acute anterior ST-segment elevation myocardial
infarction, a common and severe form of heart attack.
Those patients were randomized 2:1 to receive intracoronary
injections of KAI-9803 or a placebo in four dose groups
(0.05 mg, 0.5 mg, 1.25 mg or 5.0 mg).
Patients at all dose levels demonstrated less myocardial
necrosis (destruction of the heart muscle cells) and improved
electrical activity of the heart (an indicator of heart
muscle health). The median reduction in myocardial necrosis
ranged from 18 percent to 25 percent across the four dose
groups. Similarly, the median improvement in electrical
activity of the heart ranged from 20 percent to 48 percent.
In addition, a 19 percent to 24 percent reduction in infarct
size (area of heart tissue damage) was observed in the
first three dose groups. The incidence of adverse events
was similar among patients treated with KAI-9803 and placebo,
including at the highest dose levels of the study.
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