Printer Friendly
The Free Library
4,658,636 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Aethlon Medical to Pursue U.S. Government Biodefense Contract.


SAN DIEGO -- Aethlon Medical, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:AEMD AEMD Automotive Electric Motor Drive (US Department of Energy program) ) announced today that it will submit a contract response to a BROAD AGENCY ANNOUNCEMENT (BAA) solicitation entitled "Application of Platform Technologies for the Development of Therapeutic Agents for Biodefense". This solicitation (DMID-NIAID-NIHAI20080022BARDA BARDA Bulgarian Association of Regional Development Agencies ) represents a partnership between the National Institute of Allergy and Infectious Diseases (NIAID NIAID National Institute of Allergy and Infectious Diseases. ) and the recently established Biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 Advanced Research and Development Authority (BARDA) to award contracts that fund the development and evaluation of innovative approaches to treat NIAID category A, B and C bioterror threats. Contract recipients will be awarded up to five years of funding directed toward activities including, research, clinical programs, and the establishment of large-scale manufacturing protocols. The submission deadline is June 4, 2008. A significant emphasis of the contract solicitation is to aid in the development of broad-spectrum therapies able to demonstrate effectiveness against multiple bioterror pathogens and toxins.

"Based on pre-clinical data and human treatment experience, I believe our Hemopurifier[R] is the most advanced broad-spectrum treatment for viral pathogens identified as bioterror threats," stated James A. Joyce, chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Aethlon Medical. To reinforce the broad spectrum capabilities of the Hemopurifier[R], Aethlon's contract response will include in vitro effectiveness data against Dengue dengue
 or breakbone fever or dandy fever

Infectious, disabling mosquito-borne fever. Other symptoms include extreme joint pain and stiffness, intense pain behind the eyes, a return of fever after brief pause, and a characteristic rash.
 hemorrhagic fever, Ebola hemorrhagic fever Noun 1. Ebola hemorrhagic fever - a severe and often fatal disease in humans and nonhuman primates (monkeys and chimpanzees) caused by the Ebola virus; characterized by high fever and severe internal bleeding; can be spread from person to person; is largely limited to , Lassa hemorrhagic fever, H5N1 avian influenza (Bird Flu), the reconstructed 1918 influenza virus, West Nile virus West Nile virus, microorganism and the infection resulting from it, which typically produces no symptoms or a flulike condition. The virus is a flavivirus and is related to a number of viruses that cause encephalitis. , Human immunodeficiency virus human immunodeficiency virus
n.
HIV.


Human immunodeficiency virus (HIV)
A transmissible retrovirus that causes AIDS in humans.
 (HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. ), Hepatitis-C virus (HCV HCV
abbr.
hepatitis C virus


HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus.
), and vaccinia vac·cin·i·a
n.
1. See cowpox.

2. An infection induced in humans by inoculation with the vaccinia virus in order to confer resistance to smallpox; it is usually limited to the site of inoculation.
 and monkeypox, which both represent models associated with human smallpox infection.

The BAA solicitation also emphasizes that candidate treatment countermeasures will complete a phase I human safety study within a five-year contract period. To comply with this stipulation, Aethlon's contract response will include human safety data from clinical programs conducted at the Apollo Hospital and the Fortis Hospital, both in Delhi, India. Additionally, Aethlon will provide the investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  (IDE) already submitted to the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) that requests permission to initiate human safety studies of the Hemopurifier[R] as a broad-spectrum treatment countermeasure against select bioterror and pandemic threats. As human efficacy studies against bioterror threats are not permissible for obvious humanitarian reasons, the demonstration of safety remains the sole regulatory challenge in humans. Aethlon plans to request permission to initiate the IDE-related human study soon after its contract response to the BAA solicitation.

"Now that broad-spectrum therapies have evolved to become a focal point of U.S. biodefense programs, I am optimistic that the BAA contract solicitation will be the first of several opportunities to collaborate with our government to advance the commercialization of our Hemopurifier[R] as a treatment against some of the world's deadliest pathogens," stated Joyce. "Additionally, successful navigation of these opportunities may reduce our future dependence on financing from the financial markets," concluded Joyce.

Virtually all of the pathogens considered to be material bioterror threats are untreatable Un`treat´a`ble

a. 1. Incapable of being treated; not practicable.
 with traditional drug and vaccine therapies. Effective treatments are either non-existent, of limited usefulness, or vulnerable to both naturally emerging and intentionally engineered pathogens. Innovative therapies offering broad-spectrum activity against different classes of microbes could potentially be effective against both traditional and non-traditional threats. Broad-spectrum therapies also provide the possibility that a limited number of treatment countermeasures could replace the need for the staggering number of pathogen-specific drugs that would be required for emergency use in bioterror and pandemic threat programs. Additionally, broad-spectrum strategies that are able to overcome drug resistance could extend the clinical utility of existing therapies. For these reasons, the U.S. Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979
Health and Human Services, HHS
 (HHS HHS Department of Health and Human Services. ) recently mandated that therapies able to demonstrate broad-spectrum effectiveness against multiple pathogens are to be the focal point of government programs that fund the development and commercialization of countermeasures against bioterror and pandemic threats. Aethlon Medical considers the Hemopurifier[R] to be the leading broad-spectrum candidate as evidenced by its breadth of pre-clinical data and human treatment experience.

About Aethlon Medical

Aethlon Medical is the developer of the Hemopurifier[R], a first-in-class medical device designed to treat infectious disease. The Hemopurifier[R] provides real-time therapeutic filtration of infectious viruses and immunosuppressive Immunosuppressive
Any agent that suppresses the immune response of an individual.

Mentioned in: Antirheumatic Drugs, Graft-vs.-Host Disease, Immunosuppressant Drugs


immunosuppressive

1. pertaining to or inducing immunosuppression.

2.
 particles, and is positioned to address the treatment of drug and vaccine resistant viruses. Additionally, the device holds promise in cancer care, as research studies have verified the Hemopurifier[R] is able to capture immunosuppressive particles secreted by tumors. The Hemopurifier[R] is designed to act both as a stand-alone therapeutic, and as an adjunct treatment to enhance clinical benefit of established therapies. Pre-clinical studies conducted by researchers representing leading government and non-government health organizations both in the United States and abroad have documented the effectiveness of the Hemopurifier[R] in capturing from circulation the viruses that constitute pandemic threats, including H5N1 Avian Influenza (bird flu), and Dengue Hemorrhagic Fever (DHF DHF dihydrofolate or dihydrofolic acid. ) from circulation. The company is conducting studies to support the use of the Hemopurifier[R] as a broad-spectrum treatment countermeasure against bioterror threats, including Smallpox, and Ebola, Marburg, and Lassa hemorrhagic fever. Regulatory and commercialization initiatives in the United States are presently focused on bioterror threats, while international initiatives are directed toward naturally evolving pandemic threats, and chronic infectious disease conditions including the Human Immunodeficiency Virus (HIV) and Hepatitis-C (HCV). Aethlon demonstrated the safety of the Hemopurifier[R] in a 24-treatment human study at the Apollo Hospital in Delhi, India, and is currently conducting further human studies at the Fortis Hospital, also located in Delhi. The company has submitted an investigational device exemption (IDE) to the U.S. Food and Drug Administration (FDA) to advance the Hemopurifier([R])as a broad-spectrum treatment countermeasure against category "A" bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier([R]) technology is available online at www.aethlonmedical.com.

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 that 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 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 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. Additionally, there is no assurance that the Company will be the recipient of funding awards, grants, or contracts from any government agency 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.
COPYRIGHT 2008 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2008 Gale, Cengage Learning. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Apr 23, 2008
Words:1138
Previous Article:Volvo Invests in Proxio AB, Whose Software Technology Reduces Transport Costs and Protects the Environment.
Next Article:Morgan Stanley Real Estate Raises Additional $2.5 Billion of Equity Commitments for Special Situations Fund III.
Topics:



Related Articles
AETHLON MEDICAL SIGNS MAUFACTURING PARTNERSHIP.(with Pharmaceutical Systems Inc.)(Brief Article)
Vaccine stockpiles now required by law.(Security beat: homeland defense briefs)(Brief Article)
INDIA AND CII SUPPORT AETHLON HIV/HEPATITIS TRIALS.
Biodefense experts: vaccines 'at a crossroads'.(GERM WARFARE)
AETHLON MEDICAL TO SUBMIT BIOSHIELD IDE.
Aethlon Medical Announces Government Research Collaborations.
Germ warfare: agencies scramble to create vaccine market.(BIOWARFARE)
AETHLON ANNOUNCES BIRD FLU RESEARCH COLLABORATIONS.
AETHLON FILES PATENT ON HEMOPURIFIER USE FOR BIOMARKERS.
Aethlon Medical Submits Biodefense Contract Proposal to U.S. Government.

Terms of use | Copyright © 2008 Farlex, Inc. | Feedback | For webmasters | Submit articles