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Scil Technology GmbH obtained Competent Authority Approval for Phase II Periodontitis Study |
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23 May 2007 |
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Scil Technology GmbH, a biopharmaceutical company focused on the development of dental and orthopaedic tissue regeneration products, today announced that it has obtained Competent Authority Approval for a Phase II Clinical Trial investigating its dental product, MD05, for surgical treatment of periodontal disease.
MARTINSRIED, Germany | May 22, 2007 | Scil Technology GmbH, a biopharmaceutical company focused on the development of
dental and orthopaedic tissue regeneration products, today announced that it has obtained Competent Authority Approval for a Phase II Clinical Trial investigating its dental product, MD05, for surgical treatment of periodontal disease. Scil Technology will start the process of patient recruitment to commence the trial in the next few weeks.
MD05 is a granular synthetic bone substitute, which is comprised of the synthetic carrier, beta-tricalcium phosphate coated with recombinant human growth and differentiation factor-5. It is already in clinical development for alveolar bone regeneration in dental implantology and the new Phase II trial will focus on surgical treatment of periodontal disease.
Dr. Björn Capsius, Clinical Project Leader at Scil Technology, commented:
“Conventional non-surgical and surgical periodontal treatments often result in the in-growth of the junctional epithelium into the defect site, which in turn inhibits the regeneration of the periodontal attachment apparatus. This represents a significant problem in the management of periodontal disease. Our approach is to take a regenerative approach that directly encourages the regrowth of the degraded periodontal attachment. The approval of this clinical trial is an important step for Scil Technology allowing us to investigate the regenerative periodontal potential of MD05 in man”.
Dr. Weishui Weiser, Managing Director of Scil Technology commented:
“The potential of MD05 to induce the regeneration of the periodontal attachment constitutes an essential prerequisite to a sound approach to the surgical treatment of periodontal disease. I am very pleased to have received regulatory approval to proceed with this second Phase II trial with the goal of providing benefits to patients”.
About Scil Technology GmbH
Scil Technology is a privately financed biopharmaceutical development company focused on dental and orthopaedic tissue regeneration with a particular emphasis on bone and cartilage repair. The company’s therapeutic candidates are based on recombinant human growth factors. These factors are combined with biodegradable biomaterials to generate local application forms. Scil Technology’s pipeline for dentistry includes products that are targeted at periodontal disease, dental implantology and maxillofacial surgery. Orthopaedic products are developed for treatment of traumatic lesions of bone and cartilage and osteoarthritis. Scil Technology is located in the biotechnology cluster in Martinsried, Germany.
SOURCE: Scil Technology GmbH
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