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
Bone Metabolsim Bones undergo continuous remodeling (constant formation of new bone and resorption of old bone) Balance changes with age Resorption Formation Resorption Formation Resorption Formation Bone formation exceeds resorption during growth (children/adolescents) Peak bone mass, between age of 18 and 25 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 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
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 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 Further IP filed, yet unpublished
FORTIBONE - Optimized to Stimulate Collagen Matrix Production Extraction Specific and controlled hydrolysis process Native Collagen (collagen-containing raw material) Gelatine Optimized Collagen Peptides FORTIBONE 2011 2010 GELITA GELITA. AG. Alle Copies Kopien require müssen GELITA von authorization. GELITA genehmigt werden. 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 9
FORTIBONE Pre-Clinical Research Path Rapidly absorbed, partially in intact form Distribution & accumulation in target organ Stimulatory and regulatory effect in bones 10
FORTIBONE Pre-Clinical Research Path Rapidly absorbed, partially in intact form Distribution & accumulation in target organ Stimulatory and regulatory effect in bones 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 Osteoblast Stimulation Collagen Proteoglycans Production Increase of Osteoid Increase
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 Visualhistology.com
Confidential FORTIBONE - Stimulatory Effect on Bone Extracellular Matrix 3.00 2.72 2.50 RNA-Expression (x-fold of control) 2.00 1.50 1.00 1.42 1.21 1.06 2.05 0.50 0.00 Collagen Type I Biglycan Veriscan ALPL Osteocalcin GELITA in vitro data. RNA-expression in human osteoblasts after FORTIBONE stimulation
Confidential FORTIBONE Outperforms other Collagen Peptides RNA-Expression (x-fold of control) 4.5 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 2.72 2.05 1.42 1.21 1.06 0.59 0.53 0.55 0.31 0.38 Collagen Type I Biglycan Veriscan ALPL Osteocalcin Other CP FORTIBONE GELITA in vitro data. RNA-expression in human osteoblasts after FORTIBONE stimulation
Confidential FORTIBONE - Outperforms other Collagen Peptides RNA Expression in Human Osteoblasts by other Collagen Hydrolysate Stimulation RNA-Expression (x-fold of control) 4.5 4 3.5 3 2.5 2 1.5 1 0.5 0 2.72 1.42 1.21 1.29 1.06 1.00 0.97 1.04 1.0 0.78 0.58 0.56 0.64 0.46 0.53 0.56 (LPB5030712) Collagen ~ 1.5 kd Peptid 1 Collagen ~ 3 Peptid kd 2 Collagen ~ 5 Peptid kd 3 FortiBone LPB15170811 LPB3250711 PS5270711 Collagen Type I Biglycan Versican ALPL GELITA in vitro data. RNA-expression in human osteoblasts after FORTIBONE stimulation
Confidential FORTIBONE - Proposed Extended Mode of Action Osteoclast Stimulation X X Down- Regulation Cathepsin K TRAP 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.
FORTIBONE - Scheduled Clinical Stuides Observational Study 30 subjects 5g FORTIBONE RCT-Study ca. 150 subjects 5g FORTIBONE accomodating EFSA requirements
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