SAN DIEGO - October 24, 2013 (Investorideas.com newswire) Aethlon Medical, Inc. (
OTCBB:AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
Last week, the
Wall Street Journal published an
informative article on the emergence of cancer immunotherapies designed
to augment the immune system's ability to recognize and combat
malignant tumors. The oncology community is embracing this new
treatment paradigm based on mounting clinical evidence that
immunotherapies can produce long-term responses across multiple tumor
types when combined with traditional therapies. As per the
article, industry analysts project that immunotherapies could represent
half of all cancer treatments within the next 10 years. The opportunity
in lung cancer alone was referenced as a $6 billion opportunity.
At least five major drug companies are advancing candidates,
including Bristol-Myers Squibb, whose drug Yervoy is already approved
for melanoma. Drug mechanisms that inhibit the PD-1 molecular
pathway, which cancer cells hijack to evade destruction by the body's
immune system, are a primary target in the emerging immunotherapy
pipeline. The article also balanced the compelling promise of these
candidates with the reality that PD-1 inhibitors and other
immunotherapies face significant administration and cost hurdles. Much
of the concern is associated with the challenge of stacking an
immunotherapeutic drug on top of the toxicity of established therapies
such as radiation, chemotherapy, targeted cancer agents or other PD-1
inhibitors. Beyond this challenge, the cost of combining such therapies
could prove to be prohibitive considering that Yervoy alone costs
$120,000 for four doses administered over 12 weeks.
From an Aethlon Medical perspective, the
Wall Street Journal
article serves to reinforce our vision that a medical device can
deliver immunotherapeutic benefit to both established and
candidate cancer therapies, and do so economically and without added
drug toxicity.
Our device strategy targets a survival mechanism deployed by tumors
to evade and defeat the immune system of cancer patients. This
mechanism, which is not addressed by drug therapies, is the seretion of
exosomes by cancerous tumors. Researchers have discovered that tumors
release these particles to trigger the death of cancer fighting immune
cells and facilitate the spread of metastasis. Additionally,
the systemic elimination of exosomes may represent a novel strategy to
inhibit the PD-1 molecular pathway. To date, researchers have
demonstrated that the Aethlon Hemopurifier® can capture exosomes
underlying lymphoma, melanoma, ovarian, and breast cancer. If you
are not familiar with the Hemopurifier®, it is a first-in-class medical
device that targets the rapid elimination of life-threatening infectious
viruses and tumor-secreted exosomes from circulation.
Based on the recent approval (after 5+ years of effort) of an
investigational device exemption (IDE) by FDA, we are preparing to
initiate the first U.S. studies of Hemopurifier® therapy in Hepatitis-C
(HCV) infected individuals. In studies previously conducted overseas,
Hemopurifier® therapy was demonstrated to accelerate viral load
depletion in hardest-to-treat HCV patients receiving standard-of-care
drug therapy.
As a result of crossing the IDE approval threshold, we opened the
door to advance relationships with medical institutes that have clinical
interest in expanding Hemopurifier® indications to include various
forms of cancer.
When we initiated our first cancer research activities, we were
making two intuitive yet forward-looking bets. The first was that
exosomes would emerge to become a vital therapeutic target. The second
was a belief that novel immunotherapies would rethink the landscape for
treating cancer. Today, tumor-secreted exosomes are well-documented
therapeutic targets and cancer immunotherapies are expected to take
center stage in the cancer treatment arena. There is growing hope that
the marriage of traditional cancer therapies with next-generation
immunotherapies may someday allow cancer to become a manageable
condition much like HIV-infection is managed through a cocktail of
treatment mechanisms. At Aethlon Medical, our role is to provide the
oncology community with a therapeutic tool that counters the
immunosuppressive impact of exosomes without adding drug toxicity to
companion cancer therapies.
In closing, I am providing the scientific viewpoint of Dr. Douglas
Taylor on the potential implications of Hemopurifier® therapy in cancer
care. Dr. Taylor is credited with the discovery of tumor-secreted
exosomes and is a leading published author on the topic. He is also one
of the newest members of the Aethlon family as he has accepted the
position of Chief Scientific Officer at our Exosome Sciences diagnostic
subsidiary. The following is a statement from Dr. Taylor:
Evidence indicates that molecules, such as programmed cell death-1
(PD-1) and CTLA-4, are exploited by tumors to suppress patient immune
surveillance, allowing the progression of cancers. These molecules and
their ligands negatively regulate anti-tumor immune responses,
particularly CD8+ effector T cells. Treatment of activated T cells with
anti-PD-L1 antibodies reduce T cell proliferation, which correlates with
attenuated IL-2 secretion. In vitro cytotoxicity studies and in vivo
growth inhibition can be restored utilizing anti-PD-L1 antibodies or by
genetic silencing of PD-1. The expression of PD-L1 on tumor cells
inhibits anti-tumor immunity through engagement of PD-1 on effector T
cells. Expression of PD-L1 on tumors is correlated with reduced survival
in many tumor types.
Due to the role of these molecules in immune regulation and
correlation with cancer outcomes, these pathways are being targeted for
immunotherapy. Bristol Myers' experimental PD-1 inhibitor Nivolumab and
Merck's candidate, MK-3475, block the PD-1/PD-L1 interaction, allowing
the immune system to react with the tumor cells. Yervoy targets a
similar checkpoint, inhibiting the CTLA-4 pathway. Unlike genetically
targeted drugs, which disrupt mutations that fuel tumor growth, the new
agents treat the immune system. Current interest in targeting these
molecular pathways raises a concern that their normal function acts as
to modulate the immune system to prevent attacks on healthy cells.
Studies in murine models deficient for PD-1 developed dilated
cardiomyopathy and congestive heart failure and that expression of PD-1
may also prevent autoimmune diseases. Based on the critical role of PD-1
and CTLA-4, targeting their expression may be problematic resulting in
serious side effects on the host. However, an essential component of the
activity of such molecules may be due to their presence on exosomes
released by tumor cells. We previously demonstrated the presence of
these immunoregulatory molecules on tumor-derived exosomes and their
ability to suppress T cell activation and proliferation ( Taylor et al.
Clinical Cancer Research ,
9:
5113-5119, 2003). Thus, a reasonable approach that does not result in
systemic toxicity would be the removal of these immunoregulatory
molecules. Consequently, the ability of the Hemopurifier® to remove
these circulating exosomes may provide a superior approach to treat
these patients without the generalized inhibition of the respective
molecular pathways.
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address
unmet medical needs in cancer, infectious disease, and other
life-threatening conditions. Our Aethlon ADAPT™ System is a
revenue-stage technology platform that provides the basis for a new
class of devices the rapid, yet selective removal of disease promoting
particles from the entire circulatory system. At present, The Aethlon
ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address
infectious disease and cancer, and a medical device being developed
under a 5-year contract with Defense Advanced Research Projects Agency
(DARPA) to reduce the incidence of sepsis in combat-injured soldiers.
For more information, please visit
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 company can successfully protect its intellectual
property, that removal of exosomes from the human body will impact or
lead to successful treatment of cancer, or that exosomes are the cause
of tumor growth and progression, that the FDA will not approve the
initiation of the Company's 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, 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
Published at Investorideas.com newswire
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