SAN DIEGO, May 7, 2013 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
Through the publication of CEO notes, I seek to provide shareholders and other interested parties with a level of corporate transparency often absent in the microcap marketplace. In recent notes, I reviewed various topics, including emerging opportunities in cancer and the expansion of our government contract program to create a sepsis therapeutic.
This note is specific to our most important near-term objective: the approval of a investigational device exemption (IDE) by the U.S. Food and Drug Administration (FDA) that would allow us to initiate clinical feasibility studies of Hepatitis-C (HCV) infected individuals receiving Hemopurifier® therapy. In this regard, FDA withheld clearance of our recently amended IDE based on a single information deficiency that was deemed a safety concern. Specifically, FDA has requested that we detail our training and monitoring procedures related to heparinization, which is the primary anticoagulant utilized in dialysis and other extracorporeal therapies, including our Hemopurifier®. We are assembling the requested information and expect to have our response back in the hands of FDA in the coming week. The approval of our IDE remains a critical step in our strategy to advance a first-in-class medical device to address a major-market infectious disease condition.
HCV is a blood-borne pathogen that affects upwards of 170 million persons, or 2-3% of the world's population. It is a leading cause of liver cirrhosis and transplant and there is no pre or post infection vaccine. The magnitude of the HCV therapeutic opportunity has spawned immense competition within the drug industry. According to citeline®, there are over 200 planned and ongoing Phase I-III trials of pipeline HCV drugs as of March 1, 2013. However, it should be noted that only ten companies are responsible for 83% (165/200) of the referenced HCV studies; Bristol-Myers Squibb, Gilead, Merck & Co., AbbVie, Boehringer Ingelheim, Johnson & Johnson, Roche, Vertex, Achillion and Novartis. A primary factor for this odd statistical imbalance is the reality that these organizations often acquire candidate therapies that demonstrate clinical promise.
As a medical device, we have an enduring opportunity as our Hemopurifier® is uniquely positioned as an adjuvant to either interferon-based standard of care (SOC) or emerging all-antiviral drug regimens. And, unlike adjunct drug strategies, the Hemopurifier® performs without adding drug toxicity. In studies conducted in India, a three-treatment Hemopurifier® protocol administered in combination with interferon-based SOC resulted in undetectable HCV levels in as little at seven days in hard to treat genotype-1 patients. The studies also documented the ability of the Hemopurifier® to capture as many as 300 billion copies of HCV during a single six-hour treatment. In addition to augmenting the early viral kinetic response to drug therapy, the Hemopurifier® is a candidate solution for viral rebound patients who traditionally are forced to discontinue therapy once HCV establishes resistance to their drug regimens. Such a solution would address a significant unmet medical need in HCV care.
In closing, we are confident that we can fulfill FDA's information request. In the interim, I remain grateful to loyal shareholders that support our cause and I salute the continued perseverance of my Aethlon teammates.
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a 5-year contract with Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
About The Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class medical device that selectively targets the rapid clearance of infectious viral pathogens and immunosuppressive proteins from the entire circulatory system. In the treatment of Hepatitis C virus (HCV), human studies have demonstrated that Hemopurifier® therapy may improve immediate, rapid and sustained virologic response rates when administered in the first few days of standard-of-care drug therapy. In addition to accelerating viral load depletion, post-treatment analysis of the Hemopurifier® has documented the capture of up to 300 billion HCV copies of HCV during a single six-hour treatment. Access to Hemopurifier® therapy is available on a compassionate-use basis through the Medanta Medicity Institute (Medicity), a leading center for medical tourism in India. The Medicity is offering treatment access to infected individuals who previously failed or subsequently relapsed standard-of-care drug regimens. The Hemopurifier® is also being offered as a salvage therapy to infected individuals who suffer a viral breakthrough during standard-of-care therapy. U.S. studies of the Hemopurifier® are currently pending approval of an IDE submitted to FDA.
The Aethlon Hemopurifier® and Cancer
In addition to the opportunity to address a broad-spectrum of infectious viral pathogens, the Hemopurifier® has been discovered to capture tumor-derived exosomes underlying several forms of cancer. Tumor-derived exosomes have recently emerged to be a vital therapeutic target in cancer care. These microvesicular particles suppress the immune response in cancer patients through apoptosis of immune cells and their quantity in circulation correlates directly with disease progression. Beyond possessing immunosuppressive properties, tumor-derived exosomes facilitate tumor growth, metastasis, and the development of drug resistance. By addressing this unmet medical need, the Hemopurifier® is positioned as an adjunct to improve established cancer treatment regimens.
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 from either compassionate use or non-compassionate use 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 sepsis therapies or as a standalone cancer or hepatitis C therapy or standalone sepsis 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, 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
SOURCE Aethlon Medical, Inc.