Form: 8-K

Current report filing

January 12, 2011

 

 
Exhibit 99.1
 
U.S. Department of Health and Human Services
BARDA Industry Day Presentation


Washington, DC
January 12, 20100
James A. 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 Broad-Spectrum Antiviral Platform Technology
 
 

 
The BARDA Strategic Objectives
 To identify and support the development of innovative
 broad-spectrum:
  Countermeasures
  Technologies
  Platforms
 Strategies that address traditional, enhanced, emerging,
 and advanced threats
 Adjunct or adjuvant therapies that improve
 countermeasure performance
 
 

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

 
Leverages the established infrastructure
of 90,000+ U.S. based dialysis stations
 
 

 
Additional Infrastructure to Deliver
Hemopurifier® Therapy
 CRRT machines already located in hospitals
 and clinics throughout the U.S.
 Portable pump configurations
 
 

 
Mechanism of Action
Mannose
1. Separation of particles below
 250nm from the circulatory
 system
2. Immobilized lectin affinity agents
 then selectively bind to unique
 high mannose structures resident
 on viral glycoproteins that coat
 viral pathogens
 
 

 
Lectin Binding Sites
 
 

 
Dual Benefit of Action
Antiviral & Immunotherapeutic
 Antiviral
  Rapid real-time clearance of
 infectious viral pathogens
 Immunotherapeutic
  Fulfills unmet medical need of
 clearing virally-shed
 immunosuppressive
 glycoproteins
 
 

 
 Regulatory Path: Device vs. Drug
 70 human treatment experiences
 IDE on file with FDA
 GMP manufacturing already established
 Substantial viral load reductions in human HIV and HCV studies
 Follow-on HCV studies initiated
 Proven broad-spectrum capabilities against bioterror and pandemic
 threats
Hemopurifier®
Selected Quick Facts
 
 

 
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® improves public
health emergency preparedness against:
 Traditional Threats
 Enhanced Agents
 Emerging Pathogens
 Advanced Agents
 
 

 
"The Aethlon Hemopurifier® is the
 only strategy to address the
 breadth of pathogens that could
 be weaponized as agents of
 bioterrorism."
Ken Alibek
First Deputy Director of Biopreparat
 
 

 
Traditional Threats
Known naturally occurring threats such as
Smallpox, Ebola, Marburg, Lassa
 The Hemopurifier® serves as an adjunct to improve the
 benefit of established and candidate treatment strategies
 The Hemopurifier® provides a first-line countermeasure
 strategy against threats not addressed by drug or vaccines
 
 

 
Enhanced Agents
Traditional threats that have been genetically modified to
enhance virulence or circumvent drug and vaccine therapies
 The Hemopurifier® serves as a first-line countermeasure
 against enhanced agents
 Provides adjunct strategy to strengthen benefit of
 therapies proven safe and effective against similar
 pathogen threats
 Assists in characterization of enhanced agents
 
 

 
Emerging Pathogens
Previously unrecognized pathogens that occur naturally such as
SARS or future strains of pandemic influenza
 The Hemopurifier® is a candidate first-line
 countermeasure against emerging pathogens
 Provides adjunct strategy to strengthen benefit of
 therapies proven safe and effective against similar
 pathogen threats
 Assists in early characterization of emerging
 pathogen threats
 
 

 
Advanced Agents
Novel pathogen artificially engineered to bypass traditional drug
and vaccine countermeasures or enhance disease severity
 The Hemopurifier® represents the sole first-line
 treatment strategy against advanced agents
 Assists in early characterization of advanced agents
 
 

 
The Hemopurifier® also provides a therapeutic
mechanism to address at-risk populations for whom drug
and vaccine therapies may be contraindicated
 Immunocompromised
 Children
 Pregnant women
 Senior Citizens
 
 

 
Stockpile Implications
 > 4 year shelf life
 Refrigeration not required
 Therapeutic demand in HCV, HIV, and cancer provides
 replenishing FIFO stockpile
 
 

 
Selected Examples of Therapeutic Filtration
 Kidney dialysis
 Hepatitis-C Virus
 Marburg Plasmapheresis (1990)
 Anthrax Toxin Plasmapheresis (2001)
 
 

 
2001 Anthrax Survivor
"It's hard to say what saved me, but one
 of the things was plasmapheresis.
 Honestly, without it, I would be dead."
Leroy Richmond
Anthrax infected postal worker
 
 

 

An Adaptable Platform Technology
 The Hemopurifier® provides a platform for multi-use product
 development and manufacture
 Interchanging affinity agents within our core Hemopurifier®
 cartridge expands targets beyond viral threats
 Bacterial threats such as Anthrax could be addressed through
 immobilization of corresponding anti-toxin antibodies or binding
 agents
 Radiological threats could be addressed through
 immobilization of corresponding chelating agents(s)
 
 

 
Conclusions
 The Hemopurifier® fulfills BARDA's strategy objectives
 It is an innovative broad-spectrum medical countermeasure
 Offers a strategy to address traditional, enhanced, emerging,
 and advanced threats
 Serves as an adjunct to enhance the benefit of drug and
 vaccine countermeasures
 
 

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

 
8910 University Center Lane, Suite 660
San Diego, CA. 92122
www.AethlonMedical.com
 
 

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