breast cancer news

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For Immediate Release: Aethlon Medical Introduces HER2osome™, A Novel Therapeutic Device Strategy to Address Breast Cancer San Diego, September 21, 2011 – Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today the introduction of HER2osome™, a novel medical device strategy to inhibit the progression of HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. Breast cancer represents the most common form of invasive cancer in women. HER2+ breast cancer accounts for approximately 25% of new breast cancer diagnosis. The goal of HER2osome™ therapy is to simultaneously reduce the circulatory presence of HER2 protein and breast cancer exosomes, which have increasingly become recognized as playing pivotal role in the development and progression of breast cancer. Researchers report that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to address an unmet medical need and enhance the benefit of Herceptin and standard of care chemotherapies without adding drug toxicity or interaction risks. To support the pre-clinical and clinical advancement of HER2osome™, Aethlon has submitted a funding proposal entitled, “An Innovative Device Strategy to Eliminate HER2 Breast Cancer Progression” to the Breast Cancer Research Program (BCRP) offered through the Assistant Secretary of Defense for Health Affairs, Defense Health Program. The BCRP was established in fiscal year 1992 (FY92) to support innovative research focused on eradicating breast cancer. Appropriations for the BCRP from FY92

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Page 1: Breast Cancer News

For Immediate Release:

Aethlon Medical Introduces HER2osome™, A Novel Therapeutic Device Strategy to Address Breast Cancer

San Diego, September 21, 2011 – Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in

developing therapeutic filtration devices to address infectious disease and cancer,

announced today the introduction of HER2osome™, a novel medical device strategy to

inhibit the progression of HER2+ breast cancer, which is characterized by aggressive

growth and poor prognosis resulting from the over-expression of HER2 protein. Breast

cancer represents the most common form of invasive cancer in women. HER2+ breast

cancer accounts for approximately 25% of new breast cancer diagnosis.

The goal of HER2osome™ therapy is to simultaneously reduce the circulatory presence

of HER2 protein and breast cancer exosomes, which have increasingly become

recognized as playing pivotal role in the development and progression of breast cancer.

Researchers report that breast cancer exosomes suppress the immune response, stimulate

angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of

Herceptin (trastuzumab), a leading monoclonal antibody treatment against the HER2+

breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to address an

unmet medical need and enhance the benefit of Herceptin and standard of care

chemotherapies without adding drug toxicity or interaction risks.

To support the pre-clinical and clinical advancement of HER2osome™, Aethlon has

submitted a funding proposal entitled, “An Innovative Device Strategy to Eliminate

HER2 Breast Cancer Progression” to the Breast Cancer Research Program (BCRP)

offered through the Assistant Secretary of Defense for Health Affairs, Defense Health

Program. The BCRP was established in fiscal year 1992 (FY92) to support innovative

research focused on eradicating breast cancer. Appropriations for the BCRP from FY92

Page 2: Breast Cancer News

through FY10 totaled over $2.5 billion. The FY11 appropriation is $150 million.

Principal investigators underlying the Aethlon BCRP funding proposal are Dr. CS Chen,

Chief, Division of Hematology and Oncology and Medical Director of the Loma Linda

Cancer Center, and Dr. Douglas Taylor, Professor, Department of Obstetrics &

Gynecology at University of Louisville School of Medicine.

The evolution of HER2some™ therapy is based upon an adaptable dialysis-like affinity

platform technology known as the Aethlon ADAPT™ system. Therapies evolved from

the Aethlon ADAPT™ system target the selective clearance of harmful agents from the

entire blood volume within clinically relevant time frames and without the loss of

essential blood components. Thus, overcoming the historic limitation of extracorporeal

strategies that indiscriminately adsorb or remove particles solely by molecule size. In

function, the device platform allows the immobilization of single or multiple affinity

agents in the outer-capillary space of plasma filtration membrane technology as a means

to provide rapid real-time clearance of corresponding targets. In the case of

HER2osome™, the immobilization of a HER2 antibody and an exosome targeted affinity

agent provides a mechanism to clear both targets from the circulatory system of HER2+

breast cancer patients. Like all ADAPT™ derived therapies, HER2osome™ will operate

dialysate free, will not require replacement fluids, and can be utilized on dialysis

machines or CRRT systems already located in hospitals and clinics worldwide.

Aethlon has previously leveraged its ADAPT™ system through a proposal chosen for

funding through a DOD contract award under DARPA-BAA-11-30 entitled "Dialysis-

Like Therapeutics". The proposed program, which is pending completion of a

contracting phase, would support the development of a therapeutic device that reduces

the incidence of sepsis in wounded warfighters through the selective clearance of

circulating septic precursors.

The genesis of the ADAPT™ system is the Hemopurifier®, a device that immobilizes a

single lectin affinity agent to provide broad-spectrum capabilities against viral pathogens

and immunosuppressive proteins. Human studies have demonstrated the Hemopurifier®

Page 3: Breast Cancer News

to be safe and provide average viral load reductions of greater than 50% during four-hour

treatment periods in both hepatitis-C (HCV) and HIV infected individuals without the

administration of antiviral drugs. The device is currently the subject of a human clinical

study to evaluate its ability to accelerate viral load depletion when utilized in

combination with HCV standard of care drug therapy. An investigational device

exemption (IDE) to initiate clinical studies in the United States has been submitted to The

Food and Drug Administration (FDA).

In vitro studies recently documented that the Hemopurifier® also captures exosomes

underlying cancer, including colorectal, lymphoma, melanoma, ovarian, and breast

cancer. On August 24th, Aethlon expanded its exosome research programs through a

collaborative agreement with the Sarcoma Oncology Center (SOC), based in Santa

Monica, California. The SOC collaboration will study the ex vivo effectiveness of the

Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of

advanced-stage cancer patients. The study will evaluate 25 patients, five patients with

metastatic cancer of the following types; non-small cell lung cancer, prostate cancer,

melanoma, head and neck cancer, and sarcoma. Exosomes released by cancers have

emerged to become an important therapeutic target in cancer care, as they are implicated

in cancer survival, growth, and metastasis. Researchers have also identified that cancer-

released exosomes may assist tumors in evading the response of the immune system.

About Aethlon Medical The Aethlon Medical mission is to create innovative medical devices that 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. For more information, please visit www.aethlonmedical.com.

Page 4: Breast Cancer News

Certain   of   the   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,   the   ability   to   demonstrate   ex   vivo   effectiveness   of   the   Aethlon  Hemopurifier®,  the  Aethlon  ADAPT™  System,  or  the  HER2osome™  to  remove  immunosuppressive  exosomes  from  the  blood  of  advanced-­‐stage  cancer  patients,  future  therapeutic  trials   in  cancer  patients,   future   human   studies   of   the   Hemopurifier®,   the   Aethlon   ADAPT™   System,   or   the  HER2osome™   as   an   adjunct   therapy   to   improve   patient   responsiveness   to   established   cancer  therapies,   the   Hemopurifier®,   the   Aethlon   ADAPT™   System,   or   the   HER2osome™     ability   to  capture  exosomes  and   the   impact   it  may  have  on  disease   conditions,   the  Company’s  ability   to  raise   capital  when   needed,   the   Company’s   ability   to   complete   the   development   of   its   planned  products,   the  ability  of   the  Company   to  obtain  FDA  and  other   regulatory  approvals  permitting  the   sale   of   its   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.    

#  #  #    Contacts:    James  A.  Joyce  Chairman  and  CEO  858.459.7800  x301  [email protected]    Jim  Frakes  Chief  Financial  Officer  858.459.7800  x300  [email protected]