SAN DIEGO - May 14, 2014 (Investorideas.com newswire) Aethlon Medical, Inc. (
OTCBB:AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce
The discovery that our Hemopurifer® captures tumor-secreted
exosomes provides hope for a new therapeutic paradigm to augment cancer
care. Yes, the same Hemopurifier® we are preparing to advance in a
forthcoming FDA approved infectious disease study. In my last CEO note,
I referenced a National Institute of Health (NIH) – National Cancer
Institute (NCI) sponsored article that referenced Hemopurifier® therapy
as a candidate to address tumor-secreted exosomes.
The article detailed several exosomal mechanisms that promote
cancer progression, including suppression of the immune system,
triggering resistance to cancer therapies, promotion of angiogenesis and
seeding the spread of metastasis. The article also indicated that high
levels of circulating exosomes correlated with advanced stage cancer.
As researchers continue to unravel the deleterious mechanisms of
exosomes underlying cancer, it has become clear that these particles
also transport many molecular targets of interest to the pharmaceutical
industry. Thus providing further support for a medical device that is
able to target circulating exosomes without adding drug toxicity to
established cancer therapies.
In this regard, I am pleased to share the following overview
authored by Dr. Annette Marleau (our Director of Tumor Immunology),
which outlines oncology targets of the pharmaceutical industry that have
been reported to be transported by exosomes.
Therapeutic Elimination of Cancer Exosomes: Delivery Vehicles For A Spectrum of Pharmaceutical Industry Targets
The Aethlon Hemopurifier® is a first-in-class extracorporeal
hemofiltration device with the ability to capture and retain
disease-mediating particles from the entire circulatory system.
Utilizing existing hemodialysis infrastructure, Hemopurifier® cartridges
are packed with a carbohydrate-binding protein known as GNA, which has a
unique affinity for glycosylated particles that are typically released
in large quantities by diseased cells.
Among the disease targets that can be addressed by Hemopurifier®
therapy are exosomes (also sometimes referred to as extracellular
vesicles or microvesicles). Previously thought to represent unwanted
cellular debris, an explosion of research has now proven that exosomes
serve as primary transportation systems between the body's cells. In
disease conditions such as cancer, pathogenic material from diseased
cells is packaged into exosomes and released into circulation, thereby
unleashing the cancer's arsenal of malignant signals throughout the
body. In recent years, the scientific community has identified a
complement of disease-causing proteins and genes carried in the exosomal
cargo, the tumor's essential blueprint. Exosomes are thus major
purveyors of aggressive cancer phenotypes, able to provide the
comprehensive array of mediators for tumor growth and metastasis, drug
resistance, immune suppression, and angiogenesis.
Drawing from the surplus of possible targets in cancer
therapeutics, pharmaceutical companies are vying in a race for clinical
enhancement and commercialization of a plethora of drug candidates,
including tyrosine kinase inhibitors (TKI) and monoclonal antibodies
(mAb) directed at specific mediators of malignancy. We envision that
addressing exosomes therapeutically could serve as a strategy for
dealing with many of these disease targets simultaneously. Indeed, an
analysis of the drug targets being pursued by the pharmaceutical
industry reveals that many of these targets are actually transported by
cancer exosomes during the disease process. Included in the pipeline of
promising oncology drugs are immune checkpoint inhibitors targeting
programmed cell death protein 1 (also known as PD-1) and its ligand
(PD-L1, B7-H1), a molecular pathway triggered by exosomes that
contributes to muted anti-cancer responses. As underscored by the list
that follows, the drug targets present in exosomes encompass the breadth
of molecular pathways that are exploited by tumors to escape immune
surveillance and hijack host tissues, including CTLA-4, HGF/met, FGF,
b-Raf, EGFR, HER2, CD20, P-glycoprotein, and VEGF/VEGFR.
Immune Suppression
Programmed Cell Death 1 & Ligand (PD-1/PD-1L):
- Merck: Lambrolizumab/MK-3475 (anti-PD-1 mAb)
- Bristol-Myers Squibb: Nivolumab/BMS-936558 (anti-PD-1 mAb)
- CureTech/Teva: Pidilizumab/CT-011 (anti-PD-1 mAb)
- Roche/Genentech: MPDL3280A (anti-PD-L1 mAb)
- Medimmune/AstraZeneca: MEDI4736 (anti-PD-L1 mAb).
- Amplimmune/GlaxoSmithKline: AMP-224 (PD-L2-IgG1 Fc fusion protein).
CTLA-4
- Bristol-Myers Squibb: Ipilimumab/Yervoy® (anti-CTLA-4 mAb)
- Medimmune/Pfizer: Tremelimumab/CP-675-206 (anti-CTLA-4 mAb)
Tumor Growth & Metastasis
Hepatocyte growth factor (HGF) & Receptor (Met):
- Amgen: Rilotumumab/AMG 102 (anti-HGF mAb)
- Genentech/Roche: Onartuzumab/OA-5D (anti-Met mAb)
- Aveo: Ficlatuzumab/AV-299 (anti-HGF mAb)
- Amgen: AMG 337 (MET TKI)
- Eli Lilly: LY-2875358 (anti-Met mAb).
- ArQule: Tivantinib/ARQ 197 (MET TKI)
- Novartis/Incyte: INCB28060/INC280 (MET TKI)
Fibroblast growth factor (FGF)
- Novarits: Dovitinib/TK1285 (FGFR, VEGFR & PDGF TKI)
B-raf
- GlaxoSmithKline: Tafinlar™/Dabrafenib (B-raf kinase inhibitor)
- Genentech: Zelboraf®/Vemurafenib (B-raf kinase inhibitor)
Epidermal Growth Factor Receptor (EGFR)
- Genentech: Tarceva®/Erlotinib (EGFR TKI)
- Bristol-Myers Squibb & Eli Lilly: Cetuximab/Erbitux (anti-EGFR mAb)
- Amgen: Vectitbix/Panitumumab (anti-EGFR mAb)
- Boehringer Ingelheim: Gilotrif™/Afatinib (EGFR/HER2 TKI)
HER2
- Genentech: Herceptin®/Trastuzumab (anti-HER2 mAb)
- Genentech: Kadcyla®/Ado-trastuzumab emtansine (anti-HER2 mAb linked to DM1 drug)
- Genentech: Perjeta®/Pertuzimab (anti-HER2 mAb)
- GlaxoSmithKline: Tykerb/Lapatinib (dual TKI against HER2 and EGFR)
CD20
- Biogen Idec & Genentech: Rituxan®/Rituximab (anti-CD20 mAb)
- GlaxoSmithKline: Arzerra™/Ofatumumab (anti-CD20 mAb)
- Genentech: Gazyva™/Obinutuzumab (anti-CD20 mAb)
Drug Resistance
P-glycoprotein
- Novartis: Valspodar/PSC-833 (P-glycoprotein inhibitor).
Tumor Angiogenesis
Vascular endothelial growth factor (VEGF) & Receptor (VEGFR):
- Genentech/Roche: Avastin®/Bevacizumab (anti-VEGF mAb)
- Eli Lilly: Cyramza™ /Ramucirumab (anti-VEGFR2 mAb)
- Exelixis/GlaxoSmithKline: Foretnib/XL880/GSK1363089 (MET/VEGFR2 inhibitor).
- Sanofi & Regeneron: Zaltrap®/Ziv-Afibercept (VEGFR1/2 IgG1 Fc fusion protein)
Although this list of pharmaceutical targets and drugs is by no
means all-inclusive, it highlights the broad scope of cancer's cellular
pathways that can be addressed individually or in combination. While
small molecule therapies are widely used against cancer, complicating
factors include the development of resistance and debilitating side
effects in response to these agents. Given that cancer exosomes have
been reported to transport these pharmaceutical targets, therapeutic
hemofiltration of exosomes offers significant clinical potential,
whereby the tumor's complement of disease-mediating particles can be
diminished simultaneously without additive drug toxicities or
interaction risks to the patient.
About Aethlon Medical, Inc.
Aethlon Medical creates innovative medical devices to address
life-threatening diseases. The Aethlon ADAPT™ (Adaptive Dialysis-like
Affinity Platform Technology) establishes the basis for a new class of
therapeutics that target the rapid elimination of disease enabling
particles from the circulatory system of treated patients. The lead
Aethlon ADAPT™ product is the Hemopurifier®, a device that addresses a
broad-spectrum of viral pathogens as well as tumorsecreted exosomes that
suppress the immune system of cancer patients. Aethlon is also
operating under two government contracts with the Defense Advanced
Research Projects Agency (DARPA) related the development of a medical
device to reduce the incidence of sepsis. Exosome Sciences, Inc. is a
majority owned Aethlon subsidiary that is advancing exosome-based
strategies to diagnose and monitor cancer and infectious disease
progression. Additional information can be found at
www.AethlonMedical.com
Certain statements herein may be forward-looking and involve risks
and uncertainties. Such forward-looking statements involve assumptions,
known and unknown risks, uncertainties and other factors which may cause
the actual results, performance or achievements of Aethlon Medical,
Inc. to be materially different from any future results, performance, or
achievements expressed or implied by the forward-looking statements.
Such potential risks and uncertainties include, without limitation, that
the ESI will not be able to commercialize its future products, that the
FDA will not approve the initiation of the Company's existing or future
clinical programs or provide market clearance of the company's
products, future human studies whether revenue or non-revenue generating
of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct
therapy to improve patient responsiveness to established cancer or
hepatitis C therapies or as a standalone cancer or hepatitis C therapy,
the Company's ability to raise capital when needed, the Company's
ability to complete the development of its planned products, the
Company's ability to manufacture its products either internally or
through outside companies and provide its services, the impact of
government regulations, patent protection on the Company's proprietary
technology, the ability of the Company to meet the milestones
contemplated in the DARPA contract, product liability exposure,
uncertainty of market acceptance, competition, technological change, and
other risk factors. In such instances, actual results could differ
materially as a result of a variety of factors, including the risks
associated with the effect of changing economic conditions and other
risk factors detailed in the Company's Securities and Exchange
Commission filings. The Company undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a result of
new information, future events, or otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
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