rhBMP-2: origin, biology and preclinical safety

1/14/02


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Table of Contents

rhBMP-2: origin, biology and preclinical safety

PPT Slide

Origin of rhBMP-2

Properties of rhBMP-2

rhBMP-2 induces bone rat ectopic implant assay

Mechanism of bone induction

Mechanism of rhBMP-2 action

Implantation of rhBMP-2 requires a matrix

Matrix = ACS (absorbable collagen sponge)

ACS = Helistat®

PPT Slide

rhBMP-2/ACS & LT- CAGE™ device

ACS augments rhBMP-2 retention at implantation site

PPT Slide

Safety information

rhBMP-2/ACS safety studies

Biodistribution studies of rhBMP-2/ACS

rhBMP-2 is slowly released from implantation site

ADME studies of rhBMP-2

rhBMP-2 is rapidly cleared from the systemic circulation

slow release from implant site + rapid clearance from circulation

Tumor biology studies

Effect on tumor growth (in vitro)

Additional tumor studies (FDA consultation)

rhBMP-2 toxicity studies

Additional safety studies

New studies (FDA consultation)

Preclinical safety findings

Author: Administrator