RESEARCH TRIANGLE PARK, N.C., Dec. 14 /PRNewswire/ -- 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.