Title: Immune Cell Therapy PatientCustomized Cancer Therapy
1Above all else, guard your heart, it is the
wellspring of life Proverbs 423
2Forward Looking Statement
3Significance 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
4Current 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
5Goals 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
6Calcitonin 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
7Clinical ExpectationsOptimized Dose of 0.008
µg/kg/min
Source Anand 1991 Shekhar 1991
8Product 1 In-Hospital
- Provides Combined Benefits of Several Drugs
- IV Administration
- Stabilization of Symptoms
- Reduce Hospitalization Time
9Product 2 Post-Hospital
9
- Controlled Release Drug
- Easy to Administer
- Requires Only Periodic Administration
- Continuous Treatment
10Product 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
11Intellectual 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
12VasoGenix 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
13Management
- 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
14Management
- 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
15Using 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
16Pre-Clinical Research
CGRP Analog Profiling
17Using 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)
18Using SpecialistsPartners in Development
- Manufacturing
- New England Peptides, LLC
- PolyPeptide Laboratories, Inc.
- Regulatory Consulting
- Beckloff Associates, Inc.
- LIPICKY, LLC
- Clinical Testing
- Cleveland Clinic
- Averion
19Clinical Trials
Proof of Concept and Phase I/II
20Development Timeline
20
Milestone Focused Plan
21Why 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
22Previous 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
23Revenue Projection
23
One Drug ? Four Revenue Streams
24VasoGenix Pharmaceuticals 8527 Bluejacket
Street Lenexa, Kansas 66214 Dr. G. Lee
Southard Jeff Southard southardl_at_earthlink.net
jsouthard_at_vasogenix.us