SAN DIEGO, Sept. 26, 2013 /PRNewswire/ -- Aethlon Medical, Inc. (AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that the Defense Advanced Research Projects Agency (DARPA) has exercised an option agreement to proceed with year-three of a five-year $6.8 million contract that was awarded to Aethlon on September 30, 2011 under DARPA's Dialysis-Like Therapeutics (DLT) program.
The third year of Aethlon's DLT contract contains eight milestones representing a potential of $1,534,099 in revenue opportunity. To date, Aethlon has invoiced $3,188,131 to DARPA for achieving fourteen of sixteen milestone objectives targeted in the first two years of the DLT program.
The goal of the DLT program is to develop a portable device that removes "dirty" blood from the body, separates harmful agents, and returns "clean" blood to the body in a manner similar to dialysis treatment of kidney failure. The resulting device would decrease the morbidity and mortality of sepsis, thereby saving thousands of lives and billions of dollars in the United States annually. In the DLT program, Aethlon has been contracted to utilize the Aethlon ADAPT™ system to create an extracorporeal blood purification cartridge that selectively eliminates sepsis-enabling particles from circulation to promote recovery and prevent sepsis. The Aethlon ADAPT™ converges advanced plasma membrane technology with high affinity drug agents to allow the selective yet rapid clearance of disease targets from the entire circulatory system without damaging blood cells or removing particles essential for health. Aethlon has also been contracted to develop a novel blood circulatory instrument that will deliver ADAPT™ based and other therapeutic filtration devices without systemic anticoagulants normally required in extracorporeal therapies.
Beyond the civilian need for anti-sepsis therapies, the device proposed in the DLT program would play an important role in saving the lives of wounded U.S. military personnel, as infection leading to sepsis is a significant cause of mortality. When sepsis is complicated by shock, approximately half of patients do not survive for 30 days, even if effective antibiotics are used. Unfortunately, the fatality rate from sepsis can be high, given that antibiotic-resistant bacteria are an increasing problem for injured warfighters and military treatment facilities. Bio-agents engineered for resistance against antibiotics also represent a significant threat to both warfighters and citizens. Current culture-based methods of identifying blood-borne pathogens can take 48 hours or longer to identify the offending pathogen, and some blood-borne pathogens do not propagate in culture. Pending these culture results, septic patients are treated with protocol-based broad-spectrum antibiotics. In the event the offending pathogen is resistant to the empirically chosen antibiotic, the fatality rate may increase as much as 9% per hour.
Aethlon is currently preparing to launch the first U.S. studies of Hemopurifier® therapy based on the recent approval of an Investigational Device Exemption (IDE) by the United States Food and Drug Administration (FDA). Under the IDE, Aethlon will enroll ten end stage renal disease (ESRD) patients infected with HCV as part of a feasibility study to demonstrate Hemopurifier safety. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and other disease conditions.
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 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, 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.
James A. Joyce
Chairman and CEO
Chief Financial Officer
- Health Care Industry
- infectious disease