PEPTIDES AS BIOTHERAPEUTIC TOOLS PEPTIDES AS BIOTHERAPEUTIC TOOLS

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  • 1. PEPTIDES AS BIOTHERAPEUTIC TOOLS
  • 2. Intellectual Property
    • OGF and Treatment of Gastrointestinal Cancer
    • Opioid Antagonists and Growth Acceleration
    • Opioid Antagonists and Cancer Treatment
    • Molecular Biology of OGFr
      • Gene, Antisense Technology, Antibodies
    • OGF and Angiogenesis
  • 3. Scientific Teams Pancreatic Cancer Gasteroenterology Smith (MD) Surgery Conter (MD) Oncology Harvey (MD) Nursing Bingaman (RN) Evaluation Clinical Lab Demers (PhD) Statistics Mauger (PhD) Dietitian Frankenfield (MS) Psychiatry Klinger (MS) Head and Neck Cancer Otolaryngology Stack (MD) Isaacson (MD) Oncology Flood (MD) Wound Healing Ophthalmology Sassani (MD) Plastic Surgery McKay (MD) Comparative Medicine Wilson (VDM) Drug Discovery Peterson (PhD) Nuclear Imaging Tulchinsky (MD) Molecular Biology Verderame (PhD) Angiogenesis Vascular Surgery Blebea (MD) Zagon and McLaughlin
  • 4. Members of the Scientific Team
  • 5. NATURE OF THE INVENTION
    • OGF = Opioid Growth Factor Methioine Enkephalin An Inhibitory Peptide
    • OGFr = Opioid Growth Factor Receptor A Nuclear Receptor Specific Activating Ligand - OGF
    OGF OGFr Growth
  • 6. IMMEDIATE GOALS
    • Market Antibodies to OGFr for Research
    • Design and Market ELISA Kit for OGFr
    • Detection in Cancer
    • Phase II Clinical Trials with OGF:
      • Pancreatic Cancer
      • Head and Neck
    • Phase I Clinical Trial with Naltrexone (NTX)
      • Corneal Epithelial Wound Healing
      • Epithelial Repair
      • Diabetic Wound Healing
    • Design and Market Ocular Ointment of NTX for Abrasions
    • Gene Therapy with OGFr
  • 7. Treatment of Pancreatic Cancer
    • Problem: No Effective Treatment for Pancreatic Cancer
    • Solution: OGF Biotherapy
    Exogenous OGF Endogenous OGF OGF OGFr  Cancer Growth
  • 8. MARKET SIZE - PANCREATIC CANCER
    • United States
    • New Cases Annually 29,200 9th Leading Incidence
    • Death Annually 28,900 4th Leading Cause
    • World Wide
    • New Cases Annually 171,000 13th Leading Incidence
    • Death Annually 168,000 9th Leading Cause
  • 9. MILESTONES - PANCREATIC CANCER
    • Phase I Clinical Trials Completed and Approved by FDA
    • Phase II Clinical Trials - Permission Granted by FDA
    • Strategic Partnerships Under Development
    • Patents - US and Foreign
    • NIH Research Grants Awarded - Total $780,000
    • 15 Years of Basic and Preclinical Research
    • Publications in Peer-Review Journals
    • Multidisciplinary Approach
    • Team Includes Clinical and Basic Scientists
    • Use of Biotherapy
    • Emphasis on Quality of Life Issues
    • Evidence of Marked Increase in Survival
  • 10. Month s PATIENT SURVIVAL Pancreatic Cancer Phase I
  • 11. Diagnostic Test for Squamous Cell Carcinoma of the Head and Neck (SCCHN)
    • Problem: No Early Detection for SCCHN
    • High Rate of Recurrence
    • High Rate of Mortality
    • Solution: ELISA Kit for OGFr (Enzyme-linked
    • Immunosorbent Assay)
    OGF  OGFr  SCCHN Growth
  • 12. MARKET SIZE - SCCHN
    • United States
    • New Cases Annually 40,100 6th leading cancer in men
    • Death Annually 11,800
    • World Wide
    • New Cases Annually 362,000 6th leading cancer
    • Death Annually 200,000
  • 13. Patient with SCCHN
  • 14. MILESTONES - SCCHN
    • Basic and Clinical Research Team
    • Large Patient Population
    • Multidisciplinary Approach
    • Long-Term Screening
    • Basic Science Publications
    • Evidence of Loss of OGFr in SCCHN
    • Availability of Antibodies to OGFr
    • Commonly Used Approach to Detect Cancer
  • 15. Diabetic Wound Healing
    • Problem: No Treatment for Delayed and/or Abnormal Wound Healing in Diabetics
    • Solution: Use of NTX to Accelerate and Stabilize Wound Repair
    OGF OGFr NTX  Wound Healing X
  • 16. MARKET SIZE - DIABETIC WOUND HEALING
    • United States
    • Type I Diabetes - 1 million
    • Type II Diabetes - 15 million
    • Every 40 Seconds - New Case Diagnosed
    • Cost: $100 Billion, 15% of Total Health Care
    • World Wide
    • Type I and II Diabetes - 130 million
  • 17. MILESTONES - DIABETIC WOUND HEALING
    • Organized Team of Basic and Clinical Scientists
    • Large Available Patient Population
    • NIH Grant Support - Total $428,00
    • Phase 1 Clinical Trial for Systemic NTX Application Approved
    • Phase 1 Clinical Trial for Topical NTX Application Pending
    • Basic Science Evidence that NTX Accelerates Repair of Diabetic Wounds
    • Multidisciplinary Approach