Scil Technology Initiates Preclinical Proof of Concept Study for Orthopaedic Project in Spinal Fusion

MARTINSRIED, Germany, November 18, 2004 – Scil Technology, a biopharmaceutical company focused on the development of dental and orthopaedic tissue regeneration products, today announced that it has initiated its first preclinical proof-of-concept study for its lead orthopaedic project in spinal fusion, ST01.

ST01 is an artificial bone substitute material for lumbar, thoracic and cervical spinal fusion and related procedures. The product is based on a ceramic biomaterial beta-Tricalcium phosphate (β-TCP) coated with a recombinant human growth factor, a rhBMP-variant. The rhBMP- variant is a bone growth factor that encourages the growth of bone to replace the synthetic β-TCP, which is gradually resorbed over time. In this way spinal fusion is ultimately achieved with a purely synthetic biomaterial rather than the patient’s own living bone, thus avoiding additional surgery to harvest the patient´s own bone for grafting.

 It is expected that ST01 will have advantages over other BMP-2-based products, since it allows for a controlled release and reduced dosing of the rhBMP-variant, presumably leading to a favourable side effect profile (e.g., restriction of extensive bone growth). The product will furthermore provide pressure-resistant properties in order to withstand mechanical forces of soft tissue enclosing the implantation site..

Dr Irina Staatz-Granzer, Managing Director of Scil, commented:
“Earlier this year we extended our orthopaedic programme and are delighted to be taking our first identified biologically active biomaterial into preclinical proof-of-concept studies.”

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

Scil Technology’s lead orthopaedic project for spinal fusion

Scil’s orthopaedic lead is an artificial bone substitute material for lumbar, thoracic and cervical spinal fusion and related procedures. The product is based on a ceramic biomaterial beta-Tricalcium phosphate (β-TCP) coated with the recombinant human osteoinductive growth factor.

β-TCP is a synthetic calcium-based biomaterial which acts as a scaffold and space-maintainer for new bone ingrowth. It is the ‘gold standard’ in bone implantation surgery and dentistry. The rhBMP variant is a validated growth factor manufactured in E. Coli for effective bone augmentation in orthopaedic indications providing strong osteo-inductive properties.

The growth factor is applied to the granular β-TCP scaffold using the proprietary coating technology initially developed and validated for rhGDF-5. This proprietary coating technology allows for a highly homogeneous protein coating on the β-TCP matrix while maintaining the biological activity of the growth factor, avoiding structural modifications as well as aggregation of the protein.

This homogeneous coating technology has already been shown in Scil’s lead project MD05 to have a dramatic impact on the biological efficacy of the growth factor. Dose reduction and a controlled release formulation of the protein reduces the potential for harmful side effects and should prove more cost-effective.

In spinal surgery, mechanical loading conditions are a major challenge for the biomechanical properties of new artificial bone substitutes. β-TCP displays compression-resistant characteristics and has scaffold properties for cell in-growth (osteo-conduction).

Thus, the combination of  an osteoinductive growth factor and β-TCP provides ideal prerequisites for the use as bone substitute material in spinal fusion procedures.