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 muscle Inflammation
- Established Human Safety Profile
Calcitonin Gene Related Peptide
7Human 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
8Clinical ExpectationsOptimized Dose of 0.008
µg/kg/min
Source Anand 1991 Shekhar 1991
9Product 1 In-Hospital
- Provides Combined Benefits of Several Drugs
- IV Administration
- Stabilization of Symptoms
- Reduce Hospitalization Time
10Product 2 Post-Hospital
10
- Controlled Release Drug
- Easy to Administer
- Requires Only Periodic Administration
- Continuous Treatment
11Product 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
12Intellectual 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
13VasoGenix 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
14Management
- 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
15Management
- 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
16Using 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
17Pre-Clinical Research
CGRP Analog Profiling
18Using 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)
19Using SpecialistsPartners in Development
- Manufacturing
- New England Peptides, LLC
- PolyPeptide Laboratories, Inc.
- Regulatory Consulting
- Beckloff Associates, Inc.
- LIPICKY, LLC
- Clinical Testing
- Cleveland Clinic
- Averion
20Clinical Trials
Proof of Concept and Phase I/II
21Development Timeline
Exit Opportunity 1
Focused on Exit Opportunity
22Financing 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
23Summary
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
24Revenue Projection
25VasoGenix Pharmaceuticals 8527 Bluejacket
Street Lenexa, Kansas 66214 Dr. G. Lee
Southard Jeff Southard southardl_at_earthlink.net
jsouthard_at_vasogenix.us