Aethlon
Medical, AEMD, Profile, Summary
Aethlon
Medical (AEMD)
is developing innovative medical devices to address unmet medical
needs in cancer, infectious disease, and other life-threatening
conditions. Aethlon’s ADAPT™ platform provides the technology
foundation for a new class of therapeutics that target the selective
removal of disease enabling particles from the entire circulatory
system. The Aethlon ADAPT™ product pipeline includes the
Hemopurifier®, a first-in-class medical device with broad-spectrum
capabilities against exosomes that contribute to the progression of
cancer and infectious viral pathogens such as HIV and Hepatitis C.
HER2
Protein and Breast Cancer
Breast
cancer is the most common form of cancer in women, accounting for 20%
of cancer deaths with approximately 180,000 women diagnosed annually
in the United States (Merrill, R. M., and A. Sloan. 2011.
Risk-adjusted female breast cancer incidence rates in the United
States. Cancer Epidemiol.). Over-expression of the human epidermal
growth factor receptor 2 (HER2; ErbB2) gene occurs in approximately
25% of breast cancers and has been linked to poor prognosis (Slamon,
D. J., G. M. Clark, S. G. Wong, W. J. Levin, A. Ullrich, and W. L.
McGuire. 1987. Human breast cancer: correlation of relapse and
survival with amplification of the HER-2/neu oncogene. Science
235:177-182). HER2 is a receptor tyrosine kinase, member of the EGF
receptor family, which possesses proliferative and anti-apoptotic
activities.
The
standard of treatment for women diagnosed with HER2+ breast cancer
includes the humanized monoclonal antibody trastuzumab (marketed as
Herceptin®) directed against the extracellular domain of HER2.
Trastuzumab binding to HER2 mediates direct growthinhibition of tumor
cells and induces antibody-dependent cell cytotoxicity (ADCC), a
major anti-cancer mechanism by which natural killer (NK) cells lyse
antibody-coated tumor cells (Nahta, R., D. Yu, M. C. Hung, G. N.
Hortobagyi, and F. J. Esteva. 2006. Mechanisms of disease:
understanding resistance to HER2-targeted therapy in human breast
cancer. Nat Clin Pract Oncol 3:269-280).
In
patients with metastatic breast cancer undergoing chemotherapy,
treatment with trastuzumab augments overall response rates and
increases median survival time by 25% (Baselga, J. 2001. Clinical
trials of Herceptin® (trastuzumab). Eur J Cancer 37 Suppl 1:18-24).
However, response rates to trastuzumab range from 12% to 34% with
median duration of 9 months due to development of resistance. Despite
co-treatment with other HER2 targeting therapies (e.g. the tyrosine
kinase inhibitor lapatinib) and chemotherapy, patients with
metastatic breast cancer experience a limited duration of benefit;
therefore, novel treatment strategies that act synergistically or
overcome drug resistance are urgently needed (Sachdev, J. C., and M.
Jahanzeb. 2011. Blockade of the HER Family of Receptors in the
Treatment of HER2-Positive Metastatic Breast Cancer.
The
Evolution of Therapeutic Filtration to Improve Hepatitis-C Virus
(HCV) Treatment Outcomes
Therapeutic
filtration of HCV from the entire circulatory system with a medical
device has been clinically demonstrated to improve treatment outcomes
when administered at the outset of standard of care (SOC) drug
therapy. This summary overview, which includes an introduction to the
Aethlon Hemopurifier®, is for informational purposes only.
About
HCV Infection
The
U.S. National Institutes of Health (NIH) reports an estimated 180
million people worldwide are afflicted with chronic HCV infection. Of
people infected, 55 to 85% of will develop chronic infection, and 75%
of those will develop chronic liver disease. Standard of care (SOC)
drug therapy is represented by a two drug combination of interferon
and ribavirin. The primary goal of SOC drug therapy is the
achievement of a sustained virologic response (SVR), defined as
undetectable viral load six months after completion of SOC drug
therapy. According to the NIH, 15-25% of HCV infected patients will
recover
completely.
SOC
Drug Therapy Outcomes
•The
largest study of HCV infected individuals pursuing 48-week SOC drug
therapy
was a study of 4,469 genotype 1 patients published by McHutchison in
The New England Journal of Medicine in August of 2009.
•31%
(1,399 of 4,469) of patients screened for
participation were excluded from the study.
•54%
(1,654 of 3,070) of treated patients completed the SOC treatment
regimen.
•39.6%
(1,215 of 3,070) of treated patients who completed SOC therapy
achieved
a SVR.
•27%
(1,215 of 4,469) of the total patients screened for study
participation
achieved
a SVR.
•No
data recorded for patients who may have relapsed after achieving a
SVR.
The
Hemopurifier®
The
first medical device to selectively remove HCV and related
immunosuppressive proteins from circulation. A Study of the
Hemopurifier® + SOC Drug Therapy is Now Underway
•Patient
enrollment has been initiated at the Medanta Medicity Institute in
India - www.medanta.org
•Additional
details can be accessed from the Clinical Trials Registry - India
(CTRI) link: http://ctri.nic.in/clinicaltrials/index.jsp
•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)
The
Hemopurifier® Other Selected Quick Facts
•70
human treatment experiences administered to date
•An
Investigation Device Exemption (IDE) to initiate U.S. studies has
been filed with FDA
•Substantial
viral load reductions have also been observed in a human HIV study
performed in the absence of antiviral drugs
•GMP
manufacturing has been established in an FDA approved facility
•The
Hemopurifier® has proven broad-spectrum capabilities against viral
bioterror and pandemic threats
•The
device has been discovered to capture tumor-secreted exosomes known
to suppress the immune system of cancer patients
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ALS,
Hepatitis C, Traumatic Brain Injury, Blood Sepsis,breast
cancer,HIV,HPV,HCV,SOC, dialysis,DOD,UNT,USPTO,
NFL,SOCCOR,MILITARY,COMBAT MISSIONS,PTSD, Ebola
