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Peptide Hormones

Peptide Hormones. Evolving Considerations for Biotechnology and Clinical Medicine Mainstream vs. Fad Chanda Zaveri, M.S. Founder & Chairman Activor Corporation. Peptide Hormones Features & Definition. Modify protein structure and state of activity

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Peptide Hormones

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  1. Peptide Hormones Evolving Considerations for Biotechnology and Clinical Medicine Mainstream vs. Fad Chanda Zaveri, M.S. Founder & Chairman Activor Corporation

  2. Peptide HormonesFeatures & Definition • Modify protein structure and state of activity • Are not metabolized by virtue of their activity • Hormone receptors – allosteric proteins • Peptide hormones – allosteric effectors

  3. Peptide Hormone Physiology • Act on cell membrane • Act via secondary mediators • cAMP • Diacylglycerol • Calicum • Tyrosine kinase

  4. Bioengineered Peptide Hormones • Modification of existing protein • Consider primary, secondary or tertiary structure as targets • Change in structure – new physiologic effect • Creation of novel protein

  5. Secretagogues as Biotech Targets • Control peptide hormone synthesis and secretion • Three classes reported classically • Releasing factor hormones – GHRF • Central effectors • Hypoglycemia, dopamine, deep sleep, amino acids • Other peptide and steroid hormones • Cortisol, estrogen, thyroid hormone

  6. HTA-5: Novel Peptide Hormone • Primary structure derived from thymic hormone, with bioengineered modifications • Physiological effect is dose dependent and cumulative • GHRF – low dose • Immunomodulation – high dose

  7. TF-5 Literature Review •  mitogenic T-cell response (Thurman, 1975) • Modulates incidence of GVHD (Fast, 1990) • Enhances NK activity of normal LGL (Serrate 1987) and tumor bearing mice (Mastino, 1992) • Increases tumor specific immunity •  cytotoxic T-lymphocyte response (Zatz & Goldstein, 1983) •  antigen-presenting capacity of macrophages (Tzehoval, 1989) • Stimulates proliferation of, and IL-6 production in, rat splenocytes (Attia & Badamchian 1993)

  8. Growth Hormone vs. Age J. NIH Research April 1995

  9. FDA Treatment Guidelines - hGH • Hypo-Pituitarism • Adult-onset Growth Hormone Deficiency

  10. hGH SupplementationWhy are people using this? • Looking for “anti-aging” effect • Subjective Reports • Improved memory • Enhanced sexual performance • Mood elevation • More restful sleep • Enhanced exercise performance • Decrease in incidence of hot flashes

  11. Theories of Aging • Oxidative Stress Theory • Genetic Theory of Aging • Theory of Somatopause • Hormonal Theory of Aging • Links aging to a decline in the body’s secretion of hormones WITHOUT any loss in its ability to respond to these hormones

  12. Objective Reports  bone density  immune function  rate of wound healing  HDL,  LDL  in LBM,  LPL  blood pressure  cardiac output  skin thickness and hair growth General Insulin-like effect hGH Supplementation (OFF LABEL)

  13. Primary hGH Mechanism

  14. HTA-5 Pilot Study Profile • 15 Subjects • 7 Male & 8 Female • Age Range: 32 - 70 years • Test Duration: 6 weeks • Preparation: HTA-5 + Lysine + Arginine • Dosing: 1x daily • HTA-5: 20ng; Lys: 1200mg; Arg: 1200mg • Exclusion Criteria: [IGF-1]400ng/mL

  15. Subjective Reports (combined study) • Improved sleep patterns • Enhanced exercise stamina • Improvement in skin texture and thickness • Decreased rate of hair loss

  16. IGF-1 Physiology & Endpoint Considerations • Glucose Metabolism • Exerts insulin-like effect • Increases glycogen storage in SKM • Inhibits basal & insulin stimulated lipogenesis via LPL • Cholesterol Metabolism • ? Increase in hepatic cholesterol receptors • ? Suppressed synthesis • Osteoblast Metabolism • Binds to osteoblast receptor – stimulates new bone formation • IGF-2 > IGF-1

  17. IGF-1 Response MEN WOMEN HTA-5 HTA-5 + AA

  18. Male/Female IGF-1 Response • HTA-5 stimulates IGF-1 response • Avg IGF-1: 40.4%; > 50 years: 56.8% • Co-administration with known RFs - Synergistic IGF-1 response • DEDUCED: HTA-5 is GHRF • Generalizations • Female IGF-1 response is double that of males • IGF-1 response is age dependent • Endpoint data suggests a heightened female response

  19. Total Cholesterol (mg/dL) 30-45 46-59 60+

  20. Subject Cholesterol Difference Initial Final 1 231 181 -50 2 270 189 -81 3 257 241 -16 4 240 237 -3 5 241 231 -10 6 253 223 -30 7 219 209 -10 8 259 233 -26 9 239 217 -22 10 241 225 -16 11 214 203 -11 12 237 215 -22 13 218 211 -7 14 247 222 -25 15 251 239 -12 Total Cholesterol (mg/dL)

  21. Male/Female Cholesterol Response • Avg  Total Cholesterol: 23 mg/dL • Decrease in serum cholesterol • No dietary modifications • No change in medical regimen, if any • No lifestyle modifications

  22. Bone Density (g/cm2) • Radial ultrasound • Average Increase • 6.8% HTA-5 • 12.6% HTA-5 + AA MALE FEMALE

  23. Body Composition (kg) MEN WOMEN ATMLBM

  24. Body Composition Response • Objective changes in TBC • Avg %  ATM: 14.8% • Avg %  LBM: 4.1% • Slight  across age groups • Avg %  body weight: 13.2% • No dietary or lifestyle modifications

  25. Case Reports • Reversion of immuno-suppression • Cure of chronic active hepatitis B infection

  26. Biotech Industry Considerations

  27. Conclusion

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