Aethlon seeks FDA meeting for re-initiation of Hemopurifier IDE study

Aethlon Medical, Inc. (OTCBB: AEMD) announces that it has submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States.  As part of these discussions, Aethlon management will present FDA officials with new clinical data that supports the safety of the Hemopurifier® and demonstrates the capability of the medical device to reduce viral load in individuals infected with the hepatitis C virus (HCV).  Based on the data to be presented, Aethlon will request permission to expand the target treatment indications of the Hemopurifier® to include HCV in the U.S.  At present, the treatment indication underlying the Aethlon IDE is solely directed toward the use of the Hemopurifier® as a countermeasure against bioterror and pandemic threats.

"Since submitting our IDE, we have expanded our collection of human safety data, which has also provided insight that our Hemopurifier® can have a substantial effect in reducing viral load in HCV-infected patients even in the absence of antiviral drugs," stated Jim Joyce, Chairman and CEO of Aethlon Medical.  "These results combined with the emergence of a remarkable clinical validation for therapeutic filtration in HCV care provide a compelling basis for an FDA meeting to discuss and advance a potential clinical strategy to treat HCV-infected individuals in the United States."

The meeting with the FDA will provide a collaborative opportunity for Aethlon management to interact directly with Agency officials and to obtain guidance and input on advancing both its HCV and Medical Countermeasure indications in the U.S.  Aethlon anticipates a meeting with FDA officials will likely occur in mid-summer.

The Company believes a significant and enduring opportunity exists for the Hemopurifier® as an adjunct to improve the benefit of current, forthcoming and future iterations of standard-of-care drug therapy (SOC) by accelerating viral load depletion in the first few days of HCV-SOC.  The clinical validation for therapeutic filtration of HCV has been established by the VRAD system developed and marketed by Asahi Kasei Kuraray Medical in Japan.  The early administration of VRAD in combination with HCV-SOC achieved 71.4% sustained virologic response rates (SVR) in HCV patients who previously failed HCV-SOC.  These results were achieved through a once daily administration of VRAD for three consecutive days at the outset of SOC therapy.  The average viral load reduction during each treatment period, which averaged 3 1/4 hours in duration, was 26.1%.  In comparison, the Aethlon Hemopurifier® has demonstrated average viral load reductions of 64% during similar treatment timeframes in the absence of any drug therapy benefit.  Aethlon is now actively advancing an adjunct study to demonstrate the ability of the Hemopurifier® to accelerate early viral load depletion in patients who initiate HCV-SOC.  The study is being conducted at the Medanta Medicity Institute in Delhi, India.

The Hemopurifier® is also uniquely suited to treat HCV-infected End-stage renal disease (ESRD) patients, whose condition limits their ability to be treated with HCV-SOC.  The incidence of HCV infection in ESRD patients is approximately 100-1000 times higher than that in the general population. Recent studies have clearly shown that HCV-infected ESRD patients on maintenance dialysis are at increased risk of liver-related mortality.  A significant proportion develops chronic hepatitis, cirrhosis, and even hepatocellular carcinoma.  Overall, chronic HCV patients on hemodialysis bear an increased risk of liver-related morbidity and mortality, either during dialysis or after renal transplantation.  Interferon (IFN) therapy is modestly effective for the treatment of HCV infection in ESRD patients but is not recommended after renal transplantation due to the risk of acute graft rejection.  Ribavirin is considered contraindicated for the treatment of ESRD patients with chronic hepatitis C because of the risk of life-threatening hemolytic anemia.  A major advantage in treating HCV-infected ESRD patients with the Hemopurifier® is that the device adds no drug toxicity or interaction concerns and can be included in series with a patient's dialysis cartridge, thus adding no treatment burden beyond the patient's pre-established dialysis treatment schedule.

Aethlon further disclosed that it will begin discussions with the FDA on the regulatory requirements to obtain an Emergency Use Authorization (EUA) for the Hemopurifier® as a broad-spectrum countermeasure against untreatable viral threats that emerge naturally or are released by man as an agent of bioterrorism.  The Project BioShield Act of 2004 permits the FDA Commissioner to authorize the use of an unapproved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security.  The EUA authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological and nuclear agents that may be used to attack the American people or the U.S. armed forces.  The FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved and available alternatives.

Aethlon believes the Hemopurifier®, which is the sole antiviral strategy to address drug and vaccine resistant viral pathogens, is well positioned to meet the U.S. government's urgent need for innovative new medical countermeasures that can be deployed during national health emergencies.