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-FUGemcitabineOGF

Mon

ths

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