Jenken
Biosciences, Inc., an emerging specialty pharmaceutical company, today
announced that the U.S. Food and Drug Administration has cleared its
Investigational New Drug (IND) application for JKB-122, an off-patent drug
for which Jenken has discovered a potentially new therapeutic use: the
treatment or prevention of liver damage associated with hepatitis C and
other diseases associated with organ inflammation. This IND clearance
enables Jenken to commence a Phase II clinical trial of JKB-122 to
determine its ability to restore liver function in hepatitis C patients who
are unresponsive to current interferon-based therapies.
"There are approximately four million people infected with hepatitis C
in the U.S. Current therapies are either ineffective or not suitable for
many of these individuals," said Barry Buzogany, Esq., President and Chief
Executive Officer, Jenken Biosciences. "In addition to the therapeutic
potential for JKB-122, the commercial opportunity for Jenken Biosciences is
considerable. The hepatitis C drug market is approximately $3.0 billion per
year and expected to grow to $8.0 billion by 2010. We believe that our
approach to repurposing drugs, which are already known to be safe, strongly
positions Jenken because it is a model that greatly reduces the overall
development risk, cost and the time-to-market. This announcement represents
an important milestone for Jenken -- advancing our first repurposed
compound into the clinic."
The Phase II trial of JKB-122 will enroll approximately 150 patients
with hepatitis C who are unresponsive to treatment with interferon-based
therapies either alone or in combination with ribavirin, the commonly used
drug combination for the treatment of hepatitis C. The patients will be
randomized into separate treatment groups (placebo and varying doses of
JKB-122) and monitored for normalized liver function. The study will also
assess the safety and tolerability of three months of administration of the
drug. The trial is expected to begin in the first quarter of 2007 and take
12 to 24 months to complete.
JKB-122 has been shown to be effective in attenuating liver injury and
normalizing liver function in several well-established liver injury animal
models. Preliminary human data from a third party study indicate that
JKB-122 exhibits efficacy in reducing liver inflammation and in normalizing
elevated liver enzymes in alcoholic patients, consistent with the Company's
preclinical results. Treating liver inflammation could lessen or delay the
progression of inflammation and subsequently fibrotic liver disease,
thereby avoiding complications of advancing disease and the possibility of
liver transplant. Jenken expects its U.S. patent on this new therapeutic
use to issue in the coming few months.
"Jenken's proprietary technology for cytokine modulation, a specific
therapy for chronic inflammation, differs from most, if not all, of the
anti- inflammatory drugs available today," said Founder, Chairman and Chief
Scientific Officer Dr. Edwin Wu. "It offers the potential to fulfill the
unmet medical need of restoring normal liver function, regardless of the
cause of the damage or disease. And we expect it will have broader
application for inflammation associated with diseases of the kidney and
lung as well."
About Jenken Biosciences
Jenken Biosciences, Inc. is a clinical stage specialty pharmaceutical
company dedicated to "repurposing" (finding new therapeutic uses for) off-
patent, approved drugs. Jenken is currently repurposing two marketed drugs
which could revolutionize the treatment of diseases associated with chronic
organ inflammation. Jenken's drug development strategy is to reduce
time-to- market and to lower risk and development costs by re-profiling
approved drugs and their analogs or metabolites.
Jenken Biosciences, Inc.
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