Aethlon Medical, Inc. · NASDAQ:AEMD
Aethlon Medical — International Vicenza Course on Hemodialysis and CKD (June 2011)
29 slides from Aethlon Medical's conference presentation, Jun 9, 2011
Slide 1: International Vicenza Course on Hemodialysis and CKD
aR _ Rod Kenley M.S. M.M. 20" International Vicenza Course on Hemodialysis and CKD
Slide 2: Why Nephrologists Should Care About HCV: ESRD Population
rologists Should Care About HCV ESRD Population The annual incidence of HCV infection in these patients ranges from 0.2% to 6.2%, which is approximately 100-1000 times higher than that in the general population Most studies have suggested a decreased survival in HCV- infected dialysis patients (from
Slide 3: Why Nephrologists Should Care About HCV: ESRD Population
/ Nephrologists Should Care About HCV ESRD Population Liver failure is the cause of death in 8 to 28% of long- term renal transplant survivors Immunosuppression following renal transplantation could worsen the course of liver disease. One goal of HCV treatment is to decrease liver- related morbidity
Slide 4: Standard-of-Care Drug Therapy
Standard-of-Gare Drug Therapy = Pegylated Interferon (PEG-IFN) « Interferes with viral replication * Significant side-effects « Ribavirin (RBV) = Recruits immune response = Causes anemia
Slide 5: Why Nephrologists Should Care About HCV: ESRD Population
ephrologists Should Care About HCV ESRD Population There is a risk of enhancement of the ribavirin-related hemolytic anemia with a deep and long-lasting fall of the hemoglobin levels, despite an increase in erythropoietin doses. Ribavirin is generally contraindicated in patients with renal failure a
Slide 6: Why Nephrologists Should Care About HCV: General Population
ephrologists Should Care About HCV General Population 175 million people infected worldwide 75% (130 million) will progress to chronic liver disease Of those taking standard-of-care drug therapy (PEG-IFNa + Ribavirin), only 15-25% will recover completely Removal of HCV by Plasmapheresis combined wit
Slide 7: Plasmapheresis for Viral Infections?
¢ Plasmapheresis for Viral Infections? = What good does removing virions from circulation do when there are many more located in inaccessible intracellularlocations? « Host immunity required to defeat any infection (boy- in-bubble disease) Clinical outcomes are better when drug therapy is started at
Slide 8: Contribution of Plasmapheresis to Improved Clinical Outcomes
Gontribution of Plasmapheresis fOmimproved Glincal Outcomes yiacpatology Research 2007; 37: 701-710 193 chronic genotype 1b hepatitis C patients having a high RNA load 133 controls received drug therapy alone 60 received Double Filtration Plasmapheresis (DFPP) treatments plus drug therapy
Slide 9: Plasmapheresis
smapheresis
Slide 10: DFPP treatment protocol and viral load reduction
Averaged three DFPP treatments (range 1-5); one per day over consecutive days + DFPP administered the same day as the start of drug therapy Average treatment time = 3 hrs. 14 minutes « Average viral load reduction was 26% per treatment
Slide 11: Treatment Outcomes
tment Outcomes
Slide 12: Any New HCV Drugs on the Horizon?
ny ew HGV drugs on the Horizon? Telaprevir (Vertex) and Boceprevir (Merck) recently approved in U.S. Both significantly improved SVR rates. Most prevalent side affect was anemia. There are no data on the safety and efficacy of Telaprevir and Boceprevir in patients with ESRD. Additional pharmacokinet
Slide 13: Results of Telaprevir-treated Genotype Patients
Results of Telaprevir-treated Genotype ders vs. Controls s non-responder SVR% soc
Slide 14: Lectin Affinity Plasmapheresis
Wectin Affinity Plasmapheresis » Derived from the Latin word legere, meaning, "to select”. + Lectins are sugar-binding proteins that are highly specific for their sugar moieties. Found on the surface of mammalian liver cells, it is believed that these cell-surface receptors are responsible for the r
Slide 15: Lectin sugar-binding specificity
e-Demannosyland a-D- slucosyl residues ‘branched a-mannosidic structures (high a-mannose ‘ype, or hybrid type and biantennary complex type N- ‘Glycans) Fucosylated core regionof bi-and triantennary complex type N-Glycane @1anda 16 linked high mannose structures Galpl AGlewAcp1R
Slide 16: Hemopurifier Diagram
Hemopurifier Diagram 3 3
Slide 17: Affinity Plasmapheresis: Aethlon Medical Hemopurifier
finity Plasmapheresis Aethlon Medical Inc. Hemopurifier
Slide 18: Snowdrop Amaryllis lectin and mannose-rich glycoproteins
Snowdrop Amaryllis lence of mannose-rich glycoproteins elope The sugar Structures are put on by the host cell arenot under the control of the virus * arenecessary for virus survival
Slide 19: Dual Benefit of Action
Diial Benefit of Action Antiviral = Clearance of circulating virions = Enhances host defenses = Clearance of virally-shed, immunosuppressive glycoproteins
Slide 20: Hemopurifier Clinical Safety Studies
rifier® Clinical Safety Studies The two clinical safety studies were done at three sites in India on ESRD patients; + 10infected with HCV; 1 infected with HIV + 69 total patient exposures. The treatments were conducted by inserting the device in the normal dialysis extracorporeal circuit upstream of
Slide 21: Average Change in Normalized HCV Viral Load
Average Change in Normalized HCV % Viral Load vs First Control Prior to Initiating Treatment Control 20% ane Treatment Average % Change in HCV Viral Load N=24 » Average viral load reduction during treatment was 64% per treatment. + The viral load reduction remained at 13% one week after the treatmen
Slide 22: Affinity Plasmapheresis: DFPP per-treatment viral load reduction
ity Plasmapheresis ration Plasmapheresis Average DFPP Per-treatment viral load reduction % period of 3 hrs DFPP
Slide 23: Advantages of lectin affinity plasmapheresis
Lectin affinity plasmapheresis provides a selective capture mechanism thereby avoiding the loss of key biomolecules such as fibrinogen Longer and more frequent treatments are therefore possible Lectin affinity plasmapheresis removes immunosuppressive proteins shed by HCV Lectin affinity plasmapheres
Slide 24: IDS Patient Data
IDS Patient Data E HEMOPURIFIER® TREATMENTS PER WEEK
Slide 25: HCV Viral Load: drugs alone predicted vs observed
—brugsalone predicted im Drugsalone obs HCV Viral Load 3 Time (days)
Slide 26: HCV Viral Load with Hemopurifier
Meo drugs HP ahr/day —brugsalone predicted im Drugsalone obs HCV Viral Load 3 Time (days)
Slide 27: HCV Viral Load with Hemopurifier
Meo drugs HP ahr/day —brugsalone predicted —Drugs~HP ahr predicted im Drugsalone obs HCV Viral Load Time (days)
Slide 28: Next Step: Lectin Affinity PP and Hemopurifier
Next Step: Lectin Affinity PP + 30 patients: 15 control; 15 Hemopurifier 3 consecutive days SOC therapy starts immediately after LAPP Looking next to initiate trials in Europe in support of application for CE mark.
Slide 29: Hemopurifier benefits summary
Improves viral clearance without adding drug toxicity Improves viral clearance without introducing new drug interaction risks Significantly improves cure rates vs. drug therapy alone Isa therapy that could easily be provided by nephrology practices.
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