Healthy Aging with Stable and Flexible Bones GELITA Bone Structure Bone structure • 70 % inorganic minerals (mainly calcium-phosphate) • 20 % organic material from wich collagen type I is 95% • 10% water • Bone cells • osteoblasts for bone formation • osteoclasts for bone resorption © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. Bone Metabolsim • Bones undergo continuous remodeling (constant formation of new bone and resorption of old bone) • Balance changes with age Resorption Formation Bone formation exceeds resorption during growth (children/adolescents) Resorption Formation Peak bone mass, between age of 18 and 25 © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. Resorption Formation Loss of bone mass during aging (osteoporosis) Women can lose up to 20% of their bone in the first five years after menopause One in two US women over 50 have osteoporosis Osteoporosis • Bone health means development and • • • © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. maintenance of strong bones, which are resistant to fractures Osteoporosis (“porus bone”) is the thinning of bone tissue which leads to the loss of bone density over time → fragile and brittle bones Osteoporosis occurs when bone matrix is lost more quickly than the body can replace it Risk factors: age and gender (female) Role of Collagen in Bones • Collagen is essential for bone flexibility and elasticity • Bone collagen provides the framework for calcium mineralization A weak collagen matrix provides insufficient calcium binding sites © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. FORTIBONE® • Current GELITA development • A clearly defined, special composition of natural Bioactive Collagen • • • • • Peptides® Obtained by special enzymatic degradation of collagen Optimized for physiological functionality Scientifically validated in pre-clinical studies! Validation in clinical human intervention studies (ongoing) IP protected: US 5,948,766 © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. 6 FORTIBONE® - IP US 5,948,766 A method of treating osteoporosis comprising administering to a patient in need thereof a composition comprising tasteless, enzymatically hydrolyzed collagen from gelatin or animal collagenic connective tissue having an average molecular weight from 1 to 40 kD. Further IP filed, yet unpublished © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. FORTIBONE® - Optimized to Stimulate Collagen Matrix Production Specific and controlled hydrolysis process Extraction Native Collagen (collagen-containing raw material) Gelatine GELITA. Copies require GELITAvon authorization. © 2011©2010 GELITA AG. Alle Kopien müssen GELITA genehmigt werden. Optimized Collagen Peptides FORTIBONE® 8 FORTIBONE® Pre-Clinical Research Path Rapidly absorbed, partially in intact form Distribution & accumulation in target organ Excellent and rapid absorption of collagen peptides after oral uptake (Iwai et al. 2005) Significant and continuous increase of collagen-specific amino acids in human blood after collagen peptide supplementation (Beuker et al. 1993) Stimulatory and regulatory effect in bones © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. 9 FORTIBONE® Pre-Clinical Research Path Rapidly absorbed, partially in intact form Distribution & accumulation in target organ Stimulatory and regulatory effect in bones © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. 10 FORTIBONE® Pre-Clinical Research Path Rapidly absorbed, partially in intact form Distribution & accumulation in target organ Stimulatory and regulatory effect in bones © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. Detection of radioactivity in femur bones 48 hours after oral application of labelled [14C]-collagen peptide in comparison to single amino acid [14C]-proline. (CRI in vitro data, 1999) 11 Confidential FORTIBONE® - Proposed Mode of Action Stimulation Osteoblast Collagen Proteoglycans Production Increase Increase of Osteoid © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. Confidential The Role of Osteoid in Bone Mineralization • Osteoid (organic bone matrix) contains the collagen fibrils which serve as • • • framework for the inorganic components (mainly calcium-phosphate) of the bone matrix Collagen fibrils become encrusted with hydroxyapatite crystals Formation of mineralized bone matrix Once osteoblasts are encased in mineralized matrix, they stop making osteoid and become osteocytes. Osteocytes are necessary to maintain bone in its living condition Mature bone consists of a framework of organic bone matrix, heavily mineralized with carefully oriented crystals of hydroxyapatite © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. Visualhistology.com Confidential FORTIBONE® - Stimulatory Effect on Bone Extracellular Matrix 3.00 2.72 RNA-Expression (x-fold of control) 2.50 2.05 2.00 1.42 1.50 1.21 1.06 1.00 0.50 0.00 Collagen Type I Biglycan Veriscan ALPL Osteocalcin GELITA in vitro data. RNA-expression in human osteoblasts after FORTIBONE® stimulation © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. Confidential FORTIBONE® Outperforms other Collagen Peptides 4.5 RNA-Expression (x-fold of control) 4.0 3.5 2.72 3.0 2.5 2.05 2.0 1.42 1.5 1.0 0.59 1.21 0.53 0.55 Biglycan Veriscan 1.06 0.31 0.5 0.38 0.0 Collagen Type I Other CP ALPL Osteocalcin FORTIBONE GELITA in vitro data. RNA-expression in human osteoblasts after FORTIBONE® stimulation © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. Confidential FORTIBONE® - Outperforms other Collagen Peptides RNA Expression in Human Osteoblasts by other Collagen Hydrolysate Stimulation 4.5 RNA-Expression (x-fold of control) 4 3.5 3 2.72 2.5 2 1.5 1 1.42 1.21 1.06 0.58 0.78 0.5 1.29 1.00 0.97 1.04 1.0 0.53 0.64 0.56 ~ 3 Peptid kD Collagen 2 ~ 5Peptid kD Collagen 3 0.56 0.46 0 (LPB5030712) ~ 1.5 kD Collagen Peptid 1 FortiBone LPB15170811 Collagen Type I LPB3250711 Biglycan Versican PS5270711 ALPL GELITA in vitro data. RNA-expression in human osteoblasts after FORTIBONE® stimulation © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. Confidential FORTIBONE® - Proposed Extended Mode of Action Stimulation Osteoclast X Cathepsin K © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. X TRAP DownRegulation Decreased expression of degenerative proteins Confidential Reducing Effect on Bone Degradation CRI in vitro data: Bone degradation processes were down regulated in human osteoclasts by Bioactive Collagen Peptides® administration. Moreover, the collagen peptides led to a slightly decreased expression of degenerative proteins in human osteoclasts. © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. FORTIBONE® - Scheduled Clinical Stuides • Observational Study 30 subjects 5g FORTIBONE® • RCT-Study ca. 150 subjects 5g FORTIBONE® accomodating EFSA requirements © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden. FORTIBONE® • Stimulates biosynthesis of bone extracellular matrix (framework for calcium). A diet rich in specific collagen peptides together with calcium-sources causes a higher bone collagen metabolism • Down-regulates degenerative mechanisms • Improves bone stability and flexibility • Supports bone density © 2011 GELITA AG. Alle Kopien müssen von GELITA genehmigt werden.
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