Form: 8-K

Current report filing

March 1, 2011


Exhibit 99.1
 
Jim Joyce
Chairman, CEO
 
 

 
Forward Looking Statements
MY PRESENTATION CONTAINS PREDICTIONS, ESTIMATES, AND OTHER FORWARD LOOKING
STATEMENTS THAT INVOLVE RISKS AND UNCERTAINTIES, INCLUDING WHETHER AND WHEN OUR
HEMOPURIFIER® AND OTHER PRODUCT OFFERINGS ARE SUCCESSFULLY DEVELOPED AND
INTRODUCED, MARKET ACCEPTANCE OF OUR HEMOPURIFIER® AND OTHER PRODUCT OFFERINGS,
REGULATORY DELAYS, MANUFACTURING DELAYS, AND OTHER RISKS DETAILED IN OUR SEC FILINGS
ACCESSIBLE ONLINE AT WWW.SEC.GOV OR WWW.AETHLONMEDICAL.COM
 
 

 


A revolutionary platform technology
with broad therapeutic applications
against infectious disease and cancer
 
 

 
The Hemopurifier®
The first medical device to selectively remove infectious viruses
and immunosuppressive toxins from circulation
 
 

 
Dual Benefit of Action
Simultaneous Antiviral & Immunotherapeutic
 Antiviral
  Rapid real-time clearance of
 infectious viral pathogens
 Immunotherapeutic
  Clearance of virally-shed and
 cancer-secreted toxins
 
 

 
Hepatitis-C
HIV
Cancer
Biodefense
Pandemics
Our Circle of Opportunity
 
 

 
Therapeutic Filtration
The Opportunity To Transition Beyond Kidney Dialysis
 
 

 
Market Opportunity
Application
HCV
standard of care adjunct
HIV
drug resistant patients
Bioterror &
Pandemic Threats
broad-spectrum
countermeasure
CANCER
immunotherapy / diagnostic /
biomarker
 
 

 
Our Hemopurifier® has the advantage of being
delivered through an established global infrastructure
of dialysis stations (90,000+ in U.S. alone)
 
 

 
Additional Infrastructure to Deliver
Hemopurifier® Therapy Includes:
 CRRT machines already located in hospitals
 and clinics
 Portable pump configurations
 
 

 
The Future
Home Infectious Disease & Cancer Therapy
 
 

 
Genesis of our Hemopurifier®
A 2004 patent submission entitled “A Method
for Removal of Viruses from Blood by Lectin
Affinity Hemodialysis” which issued in 2007
 
 

 
 Broadened our intellectual property portfolio
 Completed 11 pre-clinical programs that have validated broad-spectrum effectiveness in
 capturing infectious viral pathogens
 Completed 3 separate human safety studies conducted at the Apollo, Fortis, and Sigma New
 Life hospitals in India. (68 treatments)
 Demonstrated substantial viral load reductions in HIV and HCV infected patients in the
 absence of drug therapy
 Initiated HCV adjunct clinical study designed to accelerate benefit of SOC drug therapy
 Submitted an IDE to the FDA to initiate human studies in the United States
 Established GMP manufacturing and have signed LOI to expand capabilities
 Completed 5 pre-clinical programs to validate capture of cancer-secreted exosomes
Since 2004
 
 

 
What Are Exosomes?

 
 

 
Exosomes Are Secreted By:
 All solid-form tumors
 Lymphomas
 Leukemias
 
 

 
Science Publications
Indicate That Exosomes
 Induce Apoptosis
 Disrupt t-cell signaling
 Inhibit cytokine production
 Angiogenesis
 Metastasis
 
 

 
Tumor Secreted Exosomes
 
 

 
Pre-Clinical Hemopurifier®
Cancer Validations
 Ovarian (2008)
 Breast (2010)
 Colorectal (2010)
 Lymphoma (2010)
 Melanoma (2010)
 Additional Studies (2011)
 
 

 
Our Exosome
Therapeutic Opportunity
 The Hemopurifier® fills a previously unmet medical need in
 cancer care
 Provides mechanism to preserve immune function
 Serves as an adjunct to improve benefit of established and
 candidate cancer therapies
 
 

 

600

 
 

 
Human Immunodeficiency Virus (HIV)
A Solution to Drug Resistance
 
 

 
HIV-AIDS Study
 Infected dialysis patient
 12 treatments / 30 days
 4 hrs per treatment
 Performed in absence of drug
 therapy
 Average per treatment viral load
 reduction of 54%
 Improved CD4 t-cell ratios
 
 

 
Bioterrorism &
Pandemic Threats
 
 

 
Why Return to the Biodefense
& Pandemic Threat Space?
 HHS is committed to increasing countermeasure support
 Focal shift from one-drug-one-bug to broad-spectrum therapies
 Countermeasures with commercial market applications now ok
 FDA approval not required for stockpile consideration
 Non-dilutive funding available in amounts not limited by our
 market value
 
 

 
U.S. Department of Health and Human Services
BARDA Industry Day Presentation

Washington, DC
January 12, 2011
James A. Joyce
Chairman, CEO
 
 

 
A Broad-Spectrum Antiviral Platform Technology
 
 

 
The New BARDA & PHEMCE
Strategic Objectives
 To identify and support the development of innovative broad-spectrum:
  Countermeasures
  Technologies
  Platforms
 Strategies that address traditional, enhanced, emerging, and advanced
 threats
 
 

 
Virus
Collaborator
Ebola
USAMRIID/CDC
Dengue
NIV/WHO
Lassa
SFBR
West Nile
Battelle
H5N1 Avian 
Battelle
1918-r Spanish Flu
Battelle
2009 H1N1 Swine
Battelle
Monkey Pox
Battelle
In Vitro Confirmations Against
Bioterror and Pandemic Threats
 
 

 
The Hemopurifier® represents the most advanced
broad-spectrum countermeasure against bioterror and
emerging pandemic threats
 
 

 
"The Aethlon Hemopurifier® is the
 only strategy to address the
 breadth of pathogens that could be
 weaponized as agents of
 bioterrorism."
Ken Alibek
Director of USSR Bioweapon Program
Author of "BIOHAZARD"
 
 

 

Current Activities
 Active CRADA with USAMRIID
 Defining program opportunities with BARDA
 Awaiting a BAA from DTRA
 Preparing response to BAA (released on 2/8/11) from DARPA
 entitled “Dialysis Like Therapeutics”
 
 

 
Hepatitis-C Virus (HCV)
Our #1 Priority
 
 

 
Why HCV?
 180 million infected
 Low response rate to peg-interferon/ribavirin standard of care
 (SOC) drug therapy
 Valuations awarded to organizations with promising adjunct
 data (Telaprevir from Vertex:VRTX $8.9 bn)
 Clinical validation that viral filtration improves HCV cure rates
 
 

 
Advantages of Therapeutic Filtration
as an Adjunct to SOC
 Improves viral clearance without adding drug toxicity
 Improves viral clearance without introducing new drug
 interaction risks
 Provides a mechanism to address all genotypes of HCV
 A device has an enduring opportunity to improve benefit of
 current and future iterations of SOC drug therapy
 
 

 
Two therapeutic filtration strategies have
been tested in HCV infected patients
 The VRAD, a market approved device from Asahi
 Kasei Kuraray Medical CO. (Japan)
 The Hemopurifier®, a clinical stage device from
 Aethlon Medical, Inc. (United States)
 
 

 
The Treatment of HCV Genotype-
1 Non-Responders
 
 

 
The Hemopurifier® vs. VRAD
Viral Depletion Analysis
 Average VRAD treatment period
 of 3 hrs 14 min with benefit of
 SOC drug therapy (n=72
 treatments)
 Average Hemopurifier® treatment
 period of 4 hrs in absence of SOC
 drug therapy benefit (n=24
 treatments)
 
 

 
The Hemopurifier® vs. VRAD
 In addition to improving viral clearance
 The Hemopurifier® provides a selective capture mechanism which allows
 for greater safety and optimization of treatment outcomes
 The Hemopurifier® removes immunosuppressive proteins shed by HCV
 that cannot be addressed by VRAD
 The Hemopurifier® is a sealed single-use disposable cartridge vs.
 multiple cartridge and pump set-required by VRAD
 
 

 
The Hemopurifier® + SOC?
 Initiated clinical study at the Medanta Medicity Institute
 Up to 30 patients / up to 6 treatments in first 3 days of SOC
 Early clinical endpoints include:
  Immediate Virologic Response (IVR)
  Rapid Virologic Response (RVR)
  Early Virologic Response (EVR)
 Commercialization triggered upon positive outcomes
 
 

 
Our foundation to drive
shareholder value in 2011
 Positive HCV data
 Transition from R&D to revenue generation
  Commercialization
  Contract-grant income
 FDA approval to initiate U.S. clinical programs
 New cancer research data
 Strategic relationships (infectious disease and cancer)
 
 

 
A revolutionary platform technology
with broad therapeutic applications
against infectious disease and cancer
 
 

 
San Diego, CA. 92122
www.AethlonMedical.com
 
 

 
Presenter Information
Jim Joyce
Chairman, CEO
Aethlon Medical, Inc.
(858) 459-7800 x301
jj@aethlonmedical.com