0001019687-14-004732.txt : 20141216 0001019687-14-004732.hdr.sgml : 20141216 20141216143730 ACCESSION NUMBER: 0001019687-14-004732 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20141211 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20141216 DATE AS OF CHANGE: 20141216 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AETHLON MEDICAL INC CENTRAL INDEX KEY: 0000882291 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY ANALYTICAL INSTRUMENTS [3826] IRS NUMBER: 133632859 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21846 FILM NUMBER: 141289322 BUSINESS ADDRESS: STREET 1: 9635 GRANITE RIDGE DRIVE, SUITE 100 CITY: SAN DIEGO STATE: CA ZIP: 92123 BUSINESS PHONE: 858-459-7800 MAIL ADDRESS: STREET 1: 9635 GRANITE RIDGE DRIVE, SUITE 100 CITY: SAN DIEGO STATE: CA ZIP: 92123 FORMER COMPANY: FORMER CONFORMED NAME: BISHOP EQUITIES INC DATE OF NAME CHANGE: 19930602 8-K 1 aethlon_8k.htm FORM 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): December 16, 2014 (December 11, 2014)

 

AETHLON MEDICAL, INC.

(Exact name of registrant as specified in its charter)

 

         

Nevada

(State or other jurisdiction

of incorporation)

 

000-21846

(Commission File Number)

 

13-3632859

(IRS Employer

Identification Number)

     

9635 Granite Ridge Drive, Suite 100

San Diego, California

(Address of principal executive offices)

 

92123

(Zip Code)

 

Registrant’s telephone number, including area code: (858) 459-7800

 

Not applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

 

     
o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
     
o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
     
o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
     
o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 
 

 

 

FORWARD-LOOKING STATEMENTS

 

This Form 8-K and other reports filed by Registrant from time to time with the Securities and Exchange Commission (collectively, the "Filings") contain or may contain forward-looking statements and information that are based upon beliefs of, and information currently available to, Registrant's management as well as estimates and assumptions made by Registrant's management. When used in the Filings the words "anticipate,” "believe," "estimate," "expect," "future," "intend," "plan" or the negative of these terms and similar expressions as they relate to Registrant or Registrant's management identify forward-looking statements. Such statements reflect the current view of Registrant with respect to future events and are subject to risks, uncertainties, assumptions and other factors relating to Registrant's industry, Registrant's operations and results of operations and any businesses that may be acquired by Registrant. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.

 

Although Registrant believes that the expectations reflected in the forward-looking statements are reasonable, Registrant cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, Registrant does not intend to update any of the forward-looking statements to conform these statements to actual results.

 

ITEM 8.01 OTHER EVENTS.

 

On December 11, 2014, the Registrant issued a press release announcing the initiation of patient recruitment to support a clinical feasibility study of Hemopurifier® therapy that is being conducted at DaVita Med Center Dialysis in Houston, Texas.

 

A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

 

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.

 

EXHIBIT NO. DESCRIPTION
   
99.1 “Aethlon Medical Initiates Patient Recruitment for FDA Approved Clinical Study”

 

 

 

 

 

1
 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

        AETHLON MEDICAL, INC.
         
       

By: /s/ James A. Joyce

        James A. Joyce
    Dated: December 16, 2014   Chief Executive Officer

EX-99.1 2 aethlon_ex9901.htm PRESS RELEASE

Exhibit 99.1

 

 

Aethlon Medical Initiates Patient Recruitment for FDA Approved Clinical Study

 

SAN DIEGO, December 11, 2014 /PRNewswire/ --Aethlon Medical, Inc. (OTCQB:AEMD), the pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, today announced the initiation of patient recruitment to support a clinical feasibility study of Hemopurifier® therapy that is being conducted at DaVita Med Center Dialysis in Houston, Texas. The study, which will enroll individuals infected with Hepatitis C virus (HCV) who are also receiving chronic dialysis therapy, is being conducted under an Investigational Device Exemption (IDE) approved by the United States Food and Drug Administration (FDA). A detailed description of the study, including treatment protocol and patient inclusion/exclusion criteria can be accessed online at www.clinicaltrials.gov

 

The Aethlon Hemopurifier is a first-in-class bio-filtration device that targets the rapid elimination of viruses and immunosuppressive proteins from the circulatory system of infected individuals. To date, Hemopurifier therapy has been administered outside the United States in the treatment of Ebola, HIV and HCV-infected individuals.

 

Under the feasibility study protocol, Aethlon will enroll ten end-stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy in an infectious disease model. Upon successful completion of the feasibility study, Aethlon plans to conduct pivotal efficacy studies required for market clearance to treat chronic viral indications.

 

The feasibility study will also contribute safety data to advance Hemopurifier therapy as a broad-spectrum countermeasure against category “A” bioterror and pandemic threats that are not addressed with proven drug or vaccine therapies. The virulence of such viral threats does not permit for human pivotal (efficacy) studies to be conducted.  In the treatment of Ebola virus, Hemopurifier therapy is available in the US under emergency-use IDE regulatory provisions. The Company plans to pursue Humanitarian Use Device (HUD) approval pathways for Ebola and orphan indications that affect fewer than 4,000 individuals in the U.S. each year.

 

Previously, in vitro studies of bioterror and pandemic threats have verified Hemopurifier capture of Ebola hemorrhagic virus, dengue hemorrhagic virus, lassa hemorrhagic virus, H5N1 avian influenza (bird flu), the reconstructed 1918 influenza virus (r1918), 2009 H1N1 influenza virus (swine flu), West Nile virus, and monkeypox, which serves as a model for human smallpox infection. These studies were conducted with leading government and non-government research organizations, including The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), The Centers for Disease Control and Prevention (CDC), The National Institute of Virology (NIV), The Battelle Biomedical Research Center (BBRC) and The Southwest Foundation for Biomedical Research (SFBR).

 

 

 

 

1
 

 

 

About Aethlon Medical, Inc.

 

Aethlon Medical creates targeted therapeutic devices to address infectious disease, cancer and neurodegenerative disorders. The company's lead product is the Aethlon Hemopurifier®, a first-in-class device that selectively targets the rapid elimination of circulating viruses and tumor-secreted exosomes that promote cancer progression.  Exosome Sciences, Inc. is a majority owned subsidiary that is advancing exosome-based products to diagnose and monitor cancer, infectious disease and neurological disorders.  For more information, please visit http://www.aethlonmedical.com/ and connect with the Company on Twitter, LinkedIn, Facebook and Google+.

 

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 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 or as a broad spectrum defense against viral pathogens, including ebola, 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:

 

Aethlon Media Contact:

Leah-Michelle Nebbia (for interviews requests)

Golin

202-585-2651

lnebbia@golin.com

 

James A. Joyce
Chairman and CEO
(Office) 858.459.7800 x301

(Cell) 619-368-2000
jj@aethlonmedical.com

 

Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com

 

 

2

 

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