Scil Technology Enrols First Patient in Phase II Sinus Lift Study
MARTINSRIED, Germany, February 14, 2006 – Scil Technology, a biopharmaceutical company focused on the development of dental and orthopaedic tissue regeneration products, today announced that it has enrolled the first patient in a Phase II Clinical Trial of its novel bone augmentation product, MD05, developed for bone regeneration in dental implantology and also in bone defects in severe periondontal disease.
The trial is performed by well experienced dental surgeons and will include patients requiring bone augmentation prior to implant insertion. MD05 has been developed to combine both, osteoinductive and osteoconductive properties to accelerate new bone formation and to shorten time for implant insertion after maxillary sinus floor augmentation (Sinus lift surgery).
Dr Irina Staatz-Granzer, Managing Director of Scil Technology, commented:
”Developing our first product up to clinical phase II and enrolling our first patient is an important step for Scil Technology. We are looking forward to receiving the first results from this study in the course of the year.“
The bone augmentation product MD05 consists of the recombinant growth and differentiation factor, rhGDF-5, a naturally occurring human protein combined with the fully synthetic inorganic carrier, ß-Tricalcium phosphate (ß-TCP). Thus the product candidate provides osteoinductive as well as osteoconductive properties in a ready-to-use, entirely resorbable and compression resistant form with an excellent safety profile.
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 therapeutic candidates are based on recombinant, highly specific human growth factors. These are combined with biodegradable biomaterials to generate local application forms. While the growth factors stimulate the tissue formation, the biomaterial is gradually absorbed and replaced by natural tissue. 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:
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: the recombinant growth factor, rhGDF-5, licenced from Biopharm, Heidelberg, a naturally occurring human protein that acts by promoting the growth of bone and the inorganic carrier, ß-Tricalcium phosphate (ß-TCP). 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. Growth factor and carrier material are combined by Scil’s proprietary technology, which allows for a homogeneous distribution of the growth factor on the carrier and maintenance of structure and function of the protein and avoidance of its aggregation.
Based on the ideal growth factor / carrier combination, MD05 provides a favourable product profile:
- Osteoinductivity
- Osteoconductivity
- Excellent safety profile
- Pressure-resistance
- Biodegradability (complete resorption)
- Fully synthetic
- Favourable handling characteristics (ready-to-use)
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