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Immune Cell Therapy PatientCustomized Cancer Therapy

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(American Heart Association 2005) Cleveland Clinic Lerner Research Institute. CGRP Receptors in Heart Failure Patients Are Upregulated 38% (American Heart ... – PowerPoint PPT presentation

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Title: Immune Cell Therapy PatientCustomized Cancer Therapy


1
Above all else, guard your heart, it is the
wellspring of life Proverbs 423
2
Forward Looking Statement
3
Significance of Heart Failure
3
  • 1 Patient Diagnosis Over Age 65
  • 1 Cause of Death Over Age 65
  • 1 Hospital Expense at 15 Billion
  • Over 1 Million Hospitalizations Annually

80 Over Age 65 Will Die of Heart Failure
4
Current Treatments
  • Diuretics to Remove Excess Fluids
  • ACE Inhibitors for Hypertension
  • Beta Blockers to Slow Heart Rate
  • Vasodilators to Reduce Heart Pumping Effort

Multiple Drugs Required for Treatment
5
Goals of Our Therapy
  • Reduce Hospital Readmission Rate by Half
  • Reduce Annual Hospital Costs by 6 Billion
  • Eliminate 400,000 Readmissions
  • Save 16,000 per Hospital Visit
  • Provide Longer and Healthier Quality of Life

6
Calcitonin Gene Related Peptide (Human CGRP)
  • Significant Body of Research
  • Clinical Profile
  • Improves Cardiac Function
  • Maintains Kidney Blood Flow
  • Cardioprotective
  • Reduces Cardiac muscle Inflammation
  • Established Human Safety Profile

Calcitonin Gene Related Peptide
7
Human CGRP Agonist Analogs
  • IP protected
  • Synthesized, characterized, tested
  • In-vitro, In-vivo bio-activity confirmation
    human aCGRP
  • Clinical Profile Expectations
  • to CGRP
  • Differentiation of effects based on structure
  • Tailorable to indication

CGRP Agonists
Could Become a Platform Technology
8
Clinical ExpectationsOptimized Dose of 0.008
µg/kg/min
Source Anand 1991 Shekhar 1991
9
Product 1 In-Hospital
  • Provides Combined Benefits of Several Drugs
  • IV Administration
  • Stabilization of Symptoms
  • Reduce Hospitalization Time

10
Product 2 Post-Hospital
10
  • Controlled Release Drug
  • Easy to Administer
  • Requires Only Periodic Administration
  • Continuous Treatment

11
Product 2 Post-Hospital
11
  • First 7 days after discharge or out-patient
  • Greatest unmet need in heart failure treatment
  • Cardiologists need treatment options
  • CGRP analog can meet the need
  • CGRP recognized as having the right therapeutic
    qualities to meet this need
  • Stabilize heart failure symptoms and reduce
    re-hospitalizations

Major Market Differentiation
12
Intellectual Property
  • 13 US and Foreign Patent Applications
  • Heart Failure
  • Acute MI
  • Renal Insufficiency
  • Controlled Release
  • CGRP and CGRP Agonist Analogs
  • 5 Patents In Process
  • New Drug Applications

Heart and Kidney Focused
13
VasoGenix Leadership Team
  • Board of Directors
  • Lee Southard, PhD Chairman
  • Richard Dunn, PhD Former Sr. VP Drug Delivery
    Research, QLT/Atrix Laboratories
  • Donald Braun, PhD Vice President, Clinical
    Research, Cancer Treatment Centers of America
  • Thomas Noffsinger, PhD Former Assistant
    Vice-Chancellor, KUMC Research Institute
  • Scientific Advisory Board
  • Clinical Research Steering Committee

Experience from Drug Discovery to FDA Approval
14
Management
  • Dr. G. Lee Southard
  • President Chief Executive Officer
  • Atrix Laboratories, Inc.
  • Founder, President, CEO CSO 19871998
  • Increased Share Price from .50 to 29
  • Company Sold to QLT Inc. for 855 million
  • Vipont Pharmaceuticals, Inc.
  • Co-founder, VP RD 1981-1986
  • Increased Share Price from .50 to 15
  • Company Sold to Colgate-Palmolive for 94 million
  • Big Pharma Executive Experience
  • Eli Lilly
  • Johnson Johnson

10 FDA Approved Drug and Device Products
15
Management
  • Jeff Southard
  • Co-Founder Vice President Drug Development
  • 6 New Drugs to Market
  • 3 New Medical Devices
  • 5 Patents Issued, 3 Patents Pending
  • 13 Publications and Presentations
  • Big Pharma and CRO Experience

20 Years Drug Discovery and Development
16
Using SpecialistsPartners in Development
  • Pre-Clinical Testing
  • Xenometrics
  • Acceleration, LLC
  • GEL Analytics, Inc.
  • Fleishman-Hillard
  • Kidney Institute of Kansas University Medical
    Center (KUMC)
  • Mid America Cardiology Associates at KUMC

17
Pre-Clinical Research
CGRP Analog Profiling
18
Using SpecialistsPartners in Development
  • Research Collaborations
  • Tulane University School of Medicine
  • CGRP Protects Heart Cells from Death During Heart
    Attack Heart Failure Conditions
  • (American Heart Association 2005)
  • Cleveland Clinic Lerner Research Institute
  • CGRP Receptors in Heart Failure Patients Are
    Upregulated 38
  • (American Heart Association 2007)

19
Using SpecialistsPartners in Development
  • Manufacturing
  • New England Peptides, LLC
  • PolyPeptide Laboratories, Inc.
  • Regulatory Consulting
  • Beckloff Associates, Inc.
  • LIPICKY, LLC
  • Clinical Testing
  • Cleveland Clinic
  • Averion

20
Clinical Trials
Proof of Concept and Phase I/II
21
Development Timeline
Exit Opportunity 1
Focused on Exit Opportunity
22
Financing to Date
22
  • Raised 4.5 Million
  • Synthesis and Characterization of New Analogs of
    CGRP In-vitro and in-vivo
  • Established clear market differentiation
  • Initial Development of Controlled Release
  • Pre-IND Meeting with FDA
  • Strengthened Intellectual Property
  • Established Development Plan

23
Summary
23
  • Exciting New Series of Compounds
  • IP Strong
  • Clear HF market application
  • Revenue Projections Excellent
  • Developmental Partners The Best
  • Two Years to Clinic
  • Four years to Exit

24
Revenue Projection
25
VasoGenix Pharmaceuticals 8527 Bluejacket
Street Lenexa, Kansas 66214 Dr. G. Lee
Southard Jeff Southard southardl_at_earthlink.net
jsouthard_at_vasogenix.us
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