Wednesday, October 31, 2012

Teijin Pharma to Initiate Clinical Trial of Medical Treatment for Lumbar Disc Herniation in U.S.

Teijin Pharma Limited will initiate a U.S.-based clinical trial of KTP-001, a revolutionary new drug injected directly into the lumbar intervertebral disc that may be used as a non-surgical option to treat lumbar disc herniation. During the Phase I/II clinical trial, Teijin Pharma will also pursue licensing opportunities with partners outside Japan. A clinical trial in Japan will be initiated depending on the progress of the U.S. trial. KTP-001 was developed jointly by Teijin Pharma and KAKETSUKEN (The Chemo-Sero-Therapeutic Research Institute) based on discoveries by Professor Hirotaka Haro, Department of Orthopaedic Surgery, Graduate School of Medicine and Engineering, University of Yamanashi and Dr. Hiromichi Komori, vice-director of Yokohama City Minato Red Cross Hospital. It shares a structure with the enzyme matrix metalloproteinase, a naturally occurring molecule that promotes spontaneous regression of hernia. KTP-001 is expected to achieve the regression of hernia with simple injections, eliminating the physical
burdens associated with conventional surgery. Injection of the drug should not require hospitalization in most cases, thereby reducing the social and economic costs of treatment. Because the active ingredient of this drug is recombinant human matrix metalloproteinase, which selectively acts upon the hernia causing it to degrade and regress, the risk of allergic reactions and other side effects are expected to be low. Lumbar disc herniation is caused when parts of a diseased intervertebral disc protrude into spinal nerves. The condition causes extreme pain in the lower back area and legs. Prevalence is increasing, currently amounting to about one million patients in Japan and more than four million in the U.S., France, Germany and the U.K. combined. Those most often affected are men in their prime working years, or in their 30's and 40's. Currently there is no medicinal option to achieve the regression of hernia. Patients must either adopt the conservative approach of waiting for spontaneous regression while mitigating pain with medication, or undergo surgery to remove the hernia. Surgery is effective in treating symptoms, but constitutes a significant physical burden for the patient. A new drug-based option for treating hernias has been long awaited by patients and physicians. About the Teijin Group Teijin (TSE 3401) is a technology-driven global group offering advanced solutions in the areas of sustainable transportation, information and electronics, safety and protection, environment and energy, and healthcare. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has some 150 companies and around 17,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY 854.4 billion (USD 10.7 billion) and total assets of JPY 762.1 billion (USD 9.5billion) in the fiscal year ending March 31, 2012.
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