Science & Technology
Science and Technology
Science and Technology
Tue, February 24, 2009
Aethlon Medical Releases Shareholder Letter to Discuss Pending Government Contract & Research Grant
SAN DIEGO--([ BUSINESS WIRE ])--Aethlon Medical, Inc. (OTCBB:AEMD) disclosed today that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.
To our Shareholders:
The purpose of this letter is to provide clarity on the status of a grant submission to The Bill & Melinda Gates Foundation and our first response to a U.S. government contract opportunity. We responded to Round 2 of the Grand Challenges Explorations Grant offered by The Bill & Melinda Gates Foundation in November. Since our submission, we have been advised that grant recipients will be notified in March, with the disclosure of awards announced by the foundation in April. Since inception of our organization, this grant represents the first request for a device able to act as an artificial adjunct to the immune system, which precisely describes the mechanism of our Hemopurifier®. In our response, we proposed to demonstrate that our device, acting as an artificial adjunct to the immune system, can reduce viral load and improve immune function in HIV infected patients, including those fully resistant to drug therapy. We remain hopeful our submission will lead to an initial collaboration with The Bill & Melinda Gates Foundation.
On June 4th of last year, we submitted a contract proposal in response to a Broad Agency Announcement (BAA) entitled, "Application of Platform Technologies for the Development of Therapeutic Agents for Biodefense." The solicitation (DMID-NIAID-NIHAI20080022BARDA) represented a partnership between the National Institute of Allergy and Infectious Diseases (NIAID) and the recently established Biomedical Advanced Research and Development Authority (BARDA) to award contracts that fund the development of innovative approaches to treat bioterror and emerging pandemic threats. In recent weeks, we have been advised that we are among the remaining candidates being considered for a contract award from BARDA. NIAID has indicated that BARDA will notify us on the status of our proposal in the coming 90 days. Please note that we are being considered for an award from BARDA, not NIAID.
We are honored to be considered for a contract award and proud that our contract response included supporting subcontractor commitments from leading government and non-government health organizations: The United States Army Medical Research Institute for Infectious Diseases (USAMRIID), Battelle Biomedical Research Center (BBRC), The Renal Research Institute (RRI), Cato Research Institute, and The University of California Davis School of veterinary medicine. 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. 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.
I believe our Hemopurifier® is the most advanced broad-spectrum treatment strategy to protect military and civilian populations from viruses considered bioterror and pandemic threats. In reality, the Hemopurifier® may represent the only therapeutic hope for protecting against the breadth of drug and vaccine resistant pathogens that could emerge naturally or purposely be weaponized as agents of bioterrorism. While biased, my observations are driven by our science and the insight garnered from meaningful biodefense industry experience. This experience includes: providing congressional testimony on bioterrorism; serving on biodefense panels at federal conferences and symposiums; participating in legislative meetings on Capitol Hill; initiating the effort that redefined treatment countermeasure to include medical devices in biodefense legislation; and being an early proponent for broad-spectrum countermeasures, which has since evolved to become a focal point of government biodefense initiatives. A paper that reviews the position of our Hemopurifier® as a bioterror and pandemic threat countermeasure can be accessed online at: [ www.aethlonmedical.com/pdfs/BroadSpectrumTreament120308.pdf ].
I am cautiously optimistic of our chances to win a contract award, but recognize the need to reign in expectations based on our non-traditional mechanism of action and the reality that our resources have not afforded the lobbying presence that might influence government contract awards for larger organizations. Regardless of outcome, there will remain a significant global demand for treatment solutions against bioterror and pandemic threats. Additionally, we are not solely reliant on our endeavors in these areas as recently obtained human treatment data indicates our Hemopurifier® may help to inhibit the progression of Hepatitis-C virus (HCV), which represents one of the world's most prevalent and difficult to treat chronic infectious disease conditions.
Recognizing the focus of this letter is pending grant and contract opportunities, I am pleased to share that the stimulus package signed into law by President Obama provided a bonus of $21.5 billion for science and research spending. The amount was higher than what was proposed by either the House ($13.2 billion) or the Senate ($17.8 billion). Of this amount, the NIH alone will receive $8.5 billion for research funding. The president called the measure "the biggest increase in basic research funding in the long history of American's noble endeavor to better understand our world." As a result, we are analyzing and plan to respond to several grant opportunities that have surfaced in the fields of infectious disease, cancer, and diagnostics.
On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
| James A. Joyce |
| Chairman, CEO |
About Aethlon Medical
Aethlon Medical creates diagnostic and therapeutic filtration devices to improve the health of individuals afflicted with infectious disease and cancer. Our lead product, the Aethlon Hemopurifier®, is a first-in-class artificial adjunct to the immune system proven to capture infectious viruses and immunosuppressive particles from the human circulatory system. The device targets to inhibit disease progression of Hepatitis-C Virus (HCV) and Human Immunodeficiency Virus (HIV), and serves as a broad-spectrum treatment countermeasure against bioterror and emerging pandemic threats. The Hemopurifier® also holds promise in cancer care, as research studies verify the Hemopurifier® effectively captures immunosuppressive exosomes that are secreted by tumors to kill-off immune cells. At present, over sixty-five (65) Hemopurifier® treatments (representing approximately 260 hours of treatment time) have been conducted in multi-site studies at the Apollo Hospital, Fortis Hospital, and Sigma New-Life Hospital in India. The studies enrolled end-stage renal disease (ESRD) patients infected with either HCV or HIV. In addition to establishing treatment safety, robust viral load reductions have been reported in HCV-infected patients who completed a three-treatment protocol during the course of one week.
Research studies have also demonstrated the Hemopurifier® is effective in capturing a broad-spectrum of viruses untreatable with drug therapy, including several of the world's deadliest bioterror and pandemic threats. These include: Dengue hemorrhagic fever (DHF), Ebola hemorrhagic fever (EHF), Lassa hemorrhagic fever (LHF), H5N1 avian influenza (Bird Flu), the reconstructed 1918 influenza virus (r1918), West Nile virus (WNV), and Vaccinia and Monkeypox (MPV), which both serve as models for human smallpox infection. The studies were conducted with the assistance of researchers representing: 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).
Beyond therapeutic market opportunities, Aethlon is leveraging principles underlying the Hemopurifier® technology platform to establish a pipeline of clinical and research diagnostic products and services. Additional information regarding Aethlon Medical can be accessed online at [ www.aethlonmedical.com ].
Certain of the statements within this shareholder letter 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 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. 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.
