SAN DIEGO, Feb. 26, 2014 /PRNewswire/ -- Aethlon Medical,
Inc. (OTCQX:AEMD), the pioneer in developing selective therapeutic
filtration devices to address infectious disease, cancer and other
life-threatening conditions, announced today that that it has
reached an agreement in principle with DaVita Clinical
Research® (DCR) to provide clinical management services that
will support forthcoming studies of the Aethlon Hemopurifier®. The
Hemopurifier® is a first-in-class therapeutic device that targets
the rapid elimination of circulating viruses and tumor-secreted
exosomes that suppress the immune system of cancer patients.
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DCR is a specialty contract research organization (CRO) with
experience in conducting more than 300 early phase clinical trials.
As a subsidiary of DaVita Healthcare Partners, DCR has access
to one third of the total US end-stage renal disease (ESRD) patient
population and maintains a network that exceeds 150 investigative
physicians practices at more than 250 clinical sites.
Aethlon previously disclosed that the United States Food and
Drug Administration (FDA) had approved an Investigational Device
Exemption (IDE) that allows the Company to initiate human
feasibility studies of the Aethlon Hemopurifier® in the United States. Under the feasibility study
protocol, Aethlon is to enroll ten ESRD patients infected with
Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier
therapy. Successful completion of the feasibility study will set
the stage for Aethlon to conduct pivotal studies required for
market clearance to treat HCV and potentially other disease
indications.
"Not long after the FDA had cleared our IDE, we were presented
an opportunity to advance a clinical relationship with DaVita
Clinical Research," stated Aethlon Chairman and CEO, Jim Joyce. "As a result, we have
transitioned our clinical plan from working with a single-site
institute to working with a single institute that has a multitude
of clinical sites across the United
States. Beyond maintaining the resources necessary to
advance our feasibility study, DaVita's proven extracorporeal
expertise, patient accrual capabilities and expansive clinical
infrastructure provide a foundation to support our long-term vision
of treating a variety of infectious disease and cancer
indications."
Aethlon further disclosed that the DCR agreement was entered
into on a non-exclusive basis and is pending the completion of a
definitive agreement, which will include a work order describing
the full scope of services to be provided by DCR to Aethlon
Medical.
DaVita Clinical Research is a wholly owned subsidiary of DaVita
HealthCare Partners (NYSE:DVA), a Fortune 500 company and parent
company of DaVita and HealthCare Partners. DaVita is a leading
provider of kidney care in the United
States and abroad, delivering dialysis services to patients
with chronic kidney failure and end stage renal disease. As of
December 31, 2013, DaVita operated or
provided administrative services at 2,074 outpatient dialysis
centers in the United States
serving approximately 168,000 patients, and at 73 centers in ten
countries outside of the United
States. HealthCare Partners(R) manages and operates medical
groups and affiliated physician networks in California, Nevada, Florida, Arizona and New
Mexico in its pursuit to deliver excellent-quality health
care in a dignified and compassionate manner. As of December 31, 2013, HealthCare Partners provided
integrated care management for approximately 765,000 managed care
patients. For more information, please visit
DaVitaHealthCarePartners.com.
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 tumor-secreted 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
SOURCE Aethlon Medical, Inc.