Scil Technology Announces Positive Results in Preclinical Proof-of-Concept Study for Orthopaedic Project in Spinal Fusion

MARTINSRIED, Germany, June 21, 2005 – Scil Technology, a biopharmaceutical company focused on the development of dental and orthopaedic tissue regeneration products, today announced that a proof-of-concept study for its lead orthopaedic product, ST01, has revealed superior efficacy to autologous bone in an in vivo preclinical study for  posterolateral interbody spinal fusion. Autologous bone is the current gold standard in spinal fusion surgery. 

ST01 is an innovative, ceramic based, fully synthetic osteoinductive, biodegradable bone graft substitute activated by a recombinant human bone morphogenic protein (BMP) variant. The product is in development for lumbar, thoracic and cervical spinal fusion and related procedures. By using its proprietary coating technology the biomaterial is homogenously coated with the growth factor, allowing an improved bioavailability and a longer dwelling time of the protein at the implantation site compared to competitor products. The protein is released from the carrier over a period of more than seven days in a highly controlled manner, which represents an important feature for safety aspects of the product. 

The ceramic β-TCP based biomaterial is an appropriate matrix for BMP due to its superior biomechanical properties. The product is compression-resistant, able to withstand mechanical pressure of soft tissue enclosing the implantation side and perfectly meets the needs of orthopaedic surgeons .

Dr Irina Staatz-Granzer, Managing Director of Scil Technology, commented:
“Scil Technology has now established itself as a leading company in regenerative bone therapies. We plan to build on this study with further preclinical investigations.”

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: i.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.