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Scil Technology GmbH obtained Competent Authority
Approval for Phase II Periodontitis Study
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.
For more information please visit:
http://www.sciltechnology.com .
Contacts:
At Scil Technology:
Dr. Weishui Weiser, Managing Director
Dr. Volker Lang, VP Corporate Development
Phone: +49 (0)89 8565 1800
www.sciltechnology.com
Media relations:
Douglas Pretsell, Ph.D., Account Director
Northbank Communications
Phone : +49 (0) 89 57 00 18 06
e-Mail: d.pretsell@northbankcommunications.com
Notes for editors:
About MD05:
MD05 consists of two components: the recombinant human growth and
differentiation factor-5 (rhGDF-5) and the inorganic carrier beta-tricalcium
phosphate (ß-TCP). GDF-5, a naturally occurring human protein that acts by
promoting the growth of bone was licensed in from Biopharm, Heidelberg, Germany.
ß-TCP, a well accepted biomaterial for bone augmentation in dentistry and
orthopaedic surgery is a synthetic biomaterial that acts as a scaffold and
space-maintainer for new bone ingrowth. These two components are combined using
Scil’s proprietary technology enabling a highly stable and homogeneous
association between them while maintaining the structural and biologic integrity
of the growth factor.
MD05 provides a favourable product profile:
• Osteoinductivity and osteoconductivity
• Excellent safety profile
• Pressure-resistance
• Biodegradability (complete resorption)
• Fully synthetic
• Favourable handling characteristics (ready-to-use)
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