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PEPTIDES AS BIOTHERAPEUTIC TOOLS
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
Scientific TeamsPancreatic Cancer Gasteroenterology Smith (MD) Surgery Conter (MD) Oncology Harvey (MD) Nursing Bingaman (RN)
EvaluationClinical 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
Members of the Scientific Team
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
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
Treatment of Pancreatic Cancer Problem: No Effective Treatment for Pancreatic
Cancer Solution: OGF Biotherapy
Exogenous OGF
Endogenous OGF
OGF OGFr Cancer Growth
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
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
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5-FU
Gemcitabine
OGF
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PATIENT SURVIVAL
Pancreatic Cancer Phase I
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
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
Patient with SCCHN
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
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
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
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