South San Francisco, CA — March 31, 2009 — KAI Pharmaceuticals, Inc., a privately
held drug discovery and development company, today announced the Company has
initiated a second Phase 2a study of KAI-1678, a first-in-class, isozyme-selective, small
peptide inhibitor of the epsilon protein kinase C pathway (epsilon PKC). The study has
begun enrollment of patients for the treatment of chronic neuropathic pain associated
with chronic postherpetic neuralgia (PHN). In December 2008, KAI announced the
initiation of its first Phase 2a study of KAI-1678 in patients with moderate-to-severe
postoperative pain following total hip or total knee replacement.
Gregory Bell, KAI’s Senior Vice President of Development and Chief Medical Officer,
commented, “Our expanded Phase 2 program allows us to study KAI-1678, a promising
non-opioid, non-NSAID, in multiple indications in both acute and chronic pain. KAI is the
first company to develop a selective inhibitor of epsilon PKC. We believe there is great
potential for this novel approach, which may avoid the side effects and limited efficacy of
currently available treatments.”
KAI’s Phase 2a PHN study is a double-blind, randomized, placebo- and activecomparator-
controlled, single-dose, crossover trial designed to evaluate the efficacy of
KAI-1678 administered by subcutaneous (SQ) infusion. The primary endpoint of the
study, which is being conducted in Australia, is the mean change from baseline in pain
intensity scores at the end of drug infusion.
KAI-1678 has been shown to be highly effective at reversing pain in preclinical models of
both neuropathic and inflammatory pain, two applications for which epsilon PKC has
been well-validated in the peer-reviewed scientific literature. The Company’s Phase 1
results indicated KAI-1678 was safe and well-tolerated in healthy volunteers.
Background on Pain
Approximately 50 million people in the United States suffer from some form of persistent
pain, while another 25 million suffer acute pain each year as a result of injury or surgery.
It is estimated that 500,000 cases of herpes zoster infection occur in the United States
each year, and approximately 10 percent of patients with herpes zoster develop
postherpetic neuralgia.
Overall, four out of ten people suffering moderate-to-severe pain were unable to find
adequate pain relief, according to a survey by the American Pain Society. There is a
major need for novel therapeutics with unique mechanisms of action that provide
effective pain relief with reduced side effects. Current treatments for pain, such as
opioids and nonsteroidal anti-inflammatory drugs (NSAIDs), can be limited by serious
side effects and inadequate efficacy.
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 currently in a Phase 2b study (PROTECTION AMI) designed to assess the effect of
KAI-9803 on reducing myocardial injury in heart attack patients. KAI’s second clinical
program, KAI-1678, has the potential to address both the inflammatory and neuropathic
pain markets and currently is in multiple Phase 2a studies.
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
CONTACTS:
CONTACT: KAI Pharmaceuticals, Inc.
Kristine M. Ball, 650-244-1131
Chief Financial Officer
Fax: 650-244-1199
kball@kaipharma.com
or
Burns McClellan, for KAI Pharmaceuticals
Media:
Justin Jackson, 212-213-0006 ext. 327
jjackson@burnsmc.com
Investors:
Juliane Snowden, 212-213-0006 ext. 343
jsnowden@burnsmc.com
