Scil Technology Announces Positive
Results in Preclinical Study of its Lead Dental Bone Augmentation
Material
MARTINSRIED, Germany, June 9, 2005 – Scil
Technology, a biopharmaceutical company focused on the development
of dental and orthopaedic tissue regeneration products, today
announced that it has successfully concluded preclinical studies
with its lead regenerative dental bone augmentation material,
MD05.
This study compared the osteoinductive bone substitute MD05
with conventional bone substitutes in the reconstruction of
defects in the cranio-maxillofacial region. The results demonstrated
that MD05 was highly superior to the conventional bone substitutes
with respect to the formation of new bone and bone marrow and
can be favourably positioned in the dental bone augmentation
market:
- MD05 has an efficacy superior to autologous bone in a 1:1
mixture with beta-TCP and does not require a second surgical
procedure. [1]
- MD05 shows a superior efficacy compared to commercially available
competitor products. [2]
- MD05 is safe, the product does not induce excessive bone
growth.
- MD05 is an osteoinductive bone substitute, which is comprised
of the synthetic carrier, beta-tricalciumphosphate coated
with recombinant human growth and differentiation factor-5.
Dr Irina Staatz-Granzer, Managing Director of Scil Technology,
commented:
“This biomaterial will be the first synthetic, fully resorbable, compression
resistant dental bone augmentation product combining osteoconductive and osteoinductive
properties to enter the clinic.”
[1] Gruber et. al, Int. Journal of Oral
Maxillofac. Implants, in preparation
[2] Pöhling
et. al, Journal of Periodontology, in preparation
About Scil Technology GmbH
Scil Technology is a private biopharmaceutical development
company focused on dental and orthopaedic tissue regeneration
with a particular emphasis on bone and cartilage repair. The
Company’s lead therapeutic candidates are based on recombinant,
highly specific human growth factors. These 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 spinal fusion, traumatic lesions of bone and cartilage
tissue and osteoarthritis. Scil Technology has emerged
from the Scil Group and is located in the biotechnology cluster
in Martinsried, Germany.
For more information please visit: http://www.scil.com
Contacts
Media relations:
Sue Charles, MA, MBA, CEO
Northbank Communications
t : +44 (0) 20 7886 8152
e: s.charles@northbankcommunications.com
Douglas Pretsell, Ph.D., Senior Account Manager
Northbank Communications
t : +44 (0) 20 7886 8158
e: d.pretsell@northbankcommunications.com
At Scil Technology:
Dr Irina Staatz-Granzer, Managing Director
Scil Technology GmbH
t: +49 (0)89 85651824
e: irina.staatz@scil.com
Notes for Editors
About MD05
MD05 has two components: a synthetic inorganic carrier, ß-Tricalcium phosphate (ß-TCP), and a recombinant growth factor - rhGDF-5, a naturally occurring human protein that acts by promoting the growth of bone. ß-TCP is a synthetic calcium-phosphate biomaterial which acts as a scaffold and space-maintainer for new bone ingrowth. It is a well accepted biomaterial for bone augmentation in dentistry and orthopaedic surgery such as e.g. spinal fusion. Scil uses a proprietary coating technology for the non-covalent association of rhGDF-5 with the surface of the ß-TCP-granules.
About this preclinical study
This study compared the osteoinductive bone substitute MD05 with conventional bone substitutes in the reconstruction of defects in the cranio-maxillofacial region. Because of its biological inertness, the calvarium (skull) is the principal site for analysing the performance of bone-regeneration materials.
Analysis of the results revealed that MD05 achieved the best macroscopic performance in terms of skull/implant attachment and solidity of the material. Bone repair assessed histomorphometrically was more than five times greater with MD05 compared to the competitor products and was mostly complete after six weeks. Also, in contrast to the other treatments, bone repair was associated with the formation of normal bone marrow and substantial decrease of fibrous tissue.
In conclusion, MD05 was vastly superior to the conventional bone substitutes with respect to the formation of new bone and bone marrow. Using MD05, complete osseous bridging of the full-thickness critical-size defects in the rat calvarium was achieved after 6 weeks in the absence of excessive bone formation.
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