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Nitto Denko Corporation (Nitto) announces the initiation of a phase-1b clinical study in the US started on September 2014, to administer a new anti-fibrosis drug in patients for the assessment of safety and efficacy.
Nitto has been developing an RNAi based drug for treating fibrosis in the liver and other organs since 2008 in collaboration with Sapporo Medical University and Hokkaido University. In March 2014, a Phase-1 clinical study in healthy volunteers was completed and no remarkable adverse events were observed, even at the highest dose tested. After thorough analysis of the data, the study results were summarized in a Clinical Study Report which concluded that the drug was safe and well tolerated. These results served as the basis of the phase-1b clinical study plan.
The clinical study plan has been approved by a central Institutional Review Board (IRB). This allows Nitto to initiate the phase-1b clinical study in subjects with moderate to severe liver fibrosis for the assessment of safety and efficacy of the drug. Following the start of the US study, Nitto will also conduct a clinical study in Japan.
The clinical studies in the US have been conducted in collaboration with RRD International, Inc* (Rockville, MD), a product development company that provides expert-level strategic, regulatory and operational support.
Nitto continues to put significant effort to deliver new drugs for fibrosis and other intractable diseases to patients in need.
*About RRD International:
RRD International is a product development company that provides integrated, expert-level strategic, regulatory and operational support to biopharmaceutical companies and investors. The Company's unique Product Development Team model (PDT) provides an effective, asset-centric alternative to traditional industry practices. While comprehensive in value, structure and function – encompassing all aspects of a development program including strategic planning, management and execution – the PDT model is also highly resource efficient with an intense focus on minimizing cost, time and risk to achieve human proof-of-concept (POC). Since 2002, RRD has worked with more than 100 organizations across all major classes and therapeutic areas
Nitto produces various products across a broad range of industries through a combination of technologies based on polymer synthesis, such as industrial tapes and electronics-related materials (e.g. optical films for LCDs.) In the medical field, Nitto has also been developing businesses related to transdermal drug delivery patches and nucleic acid synthesis. Nitto will capitalize on its experience in these areas to develop therapeutic agents in the future. Nitto will continue to create new value and businesses in the “Green (environmental), Clean (new energy) and Fine (life sciences)” business domain
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