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Kalypsys Initiates Phase IIa Clinical Trial of Topical iNOS
Inhibitor
SAN DIEGO--(BUSINESS WIRE)--December 18, 2007-- Kalypsys Inc.
today announced the initiation of a Phase IIa clinical trial of
KD7040, an inducible nitric oxide synthase (iNOS) inhibitor
formulated as a topical gel, for the treatment of postherpetic
neuralgia (PHN).
Kalypsys will conduct a double-blind, placebo-controlled trial,
which will enroll approximately 50 patients at 12-15 centers in
the United States, to demonstrate proof-of-concept for KD7040 as
a treatment for neuropathic pain. Trial participants, who have
had PHN-related pain of moderate-to-severe intensity for at
least three months, will receive KD7040 or placebo for a period
of 14 days. The endpoints of the trial include assessment of
changes in worst and average daily pain scores, as well as
impact on sleep, mood and function.
“KD7040 topical gel is our most advanced compound from a broad
portfolio that we are building to create long-term value through
the discovery and development of treatments for pain and
inflammation,” noted Paul Grint, M.D., chief medical officer for
Kalypsys. “Over the course of 2007 this project has moved in
rapid progression from first-in-human studies to the initiation
of the Phase II study. This progress demonstrates the quality
and speed with which Kalypsys is bringing novel therapeutic
candidates forward for the treatment of chronic pain
conditions.”
August Watanabe, M.D., vice chairman of Kalypsys, added, “While
our initial focus is on the investigation of the therapeutic
effects of the topical gel on PHN, we believe that KD7040 has
potential in other indications. Therefore, KD7040 has a profile
that fits nicely into a franchise focused on underserved chronic
pain markets.”
About KD7040
KD7040 topical gel is an internally discovered, proprietary,
potent and selective iNOS dimerization inhibitor. It has been
optimized to deliver efficacious doses of drug into the skin
with minimal systemic exposure.
About PHN
PHN is a chronic pain condition that may complicate an outbreak
of herpes zoster (shingles). It afflicts more than 500,000
people in the United States. Patients with shingles generally
develop a blistering rash that clears up over several weeks. PHN
occurs when nerve fibers in the skin are damaged during a
shingles episode, resulting in a localized, painful condition in
the absence of apparent skin damage. Pain may be intense and
interfere with daily activities and sleep. This complication
particularly afflicts older adults, who are at greater risk of
both developing shingles and subsequent PHN. Currently available
treatments for PHN include topical medications, tricyclic
antidepressants and antiseizure medications.
About Kalypsys
Kalypsys is a San Diego-based pharmaceutical company that is
changing the way drugs are discovered and developed. Kalypsys
seamlessly integrates its scientific expertise and technologies
to develop small molecule drugs in a fast, efficient and
effective manner. The company’s discovery and clinical pipeline
consists of drugs that target pain/inflammation and
cardiovascular/metabolic diseases. In addition to focusing on
its own products, Kalypsys partners with top-tier pharmaceutical
companies to rapidly advance the identification, development and
commercialization of new therapeutics. For more information,
call 858-754-3300 or visit
www.kalypsys.com.
Contacts
Russo Partners LLC
Tracey Milani or David Schull
619-814-3511
tracey.milani@russopartnersllc.com
david.schull@russopartnersllc.com
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