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Immune Cell Therapy PatientCustomized Cancer Therapy

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Pre-Clinical Testing. Xenometrics. Acceleration, LLC. GEL Analytics, ... Pre-Clinical Research. University of Kansas Hospital. Center for Advanced Heart Care ... – 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 Inflammation
  • Excellent Human Safety Profile

Calcitonin Gene Related Peptide
7
Clinical ExpectationsOptimized Dose of 0.008
µg/kg/min
Source Anand 1991 Shekhar 1991
8
Product 1 In-Hospital
  • Provides Combined Benefits of Several Drugs
  • IV Administration
  • Stabilization of Symptoms
  • Reduce Hospitalization Time

9
Product 2 Post-Hospital
9
  • Controlled Release Drug
  • Easy to Administer
  • Requires Only Periodic Administration
  • Continuous Treatment

10
Product 2 Post-Hospital
10
  • First 7 days after discharge
  • Greatest unmet need in heart failure treatment
  • Cardiologists are frustrated
  • Very few treatment options
  • CGRP recognized as having the right therapeutic
    qualities to meet this need
  • Stabilizes heart failure symptoms and reduces
    rehospitalizations

Major Market Differentiation
11
Intellectual Property
  • 13 US and Foreign Patent Applications
  • Heart Failure
  • Acute MI
  • Renal Insufficiency
  • Controlled Release
  • 5 Patents In Process
  • Analogs
  • Broad Drug Applications

Heart and Kidney Focused
12
VasoGenix Leadership Team
  • Board of Directors
  • Lee Southard, PhD Chairman
  • Jerome Halperin Former CEO Food Drug Law
    Institute
  • 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
13
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
14
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
15
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

16
Pre-Clinical Research
CGRP Analog Profiling
17
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)

18
Using SpecialistsPartners in Development
  • Manufacturing
  • New England Peptides, LLC
  • PolyPeptide Laboratories, Inc.
  • Regulatory Consulting
  • Beckloff Associates, Inc.
  • LIPICKY, LLC
  • Clinical Testing
  • Cleveland Clinic
  • Averion

19
Clinical Trials
Proof of Concept and Phase I/II
20
Development Timeline
20
Milestone Focused Plan
21
Why VasoGenix?
21
  • VasoGenix management has proven track record for
    success.
  • Company developmental partners are the best in
    the business.
  • Addresses greatest unmet need in heart failure
    today.
  • Early Cardiologists acceptance
  • Early human clinical data supports safety and
    efficacy Lower developmental risk.

Source PhRMA, March 2005
CGRP analogs are 1 of the 5
22
Previous Financing
22
  • Raised 4 Million to Date
  • Synthesis of New Analogs of CGRP
  • Initial Development of Controlled Release Drug
  • Pre-IND Meeting with FDA
  • Expansion of Intellectual Property
  • Established Development Plan with Kansas Partners

23
Revenue Projection
23
One Drug ? Four Revenue Streams
24
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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