SAN DIEGO, Oct. 15, 2013 /PRNewswire/ – Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
In recent months, we launched and staffed a diagnostic subsidiary, expanded our intellectual property portfolio, and continued to generate revenues from established and newly awarded government contracts. More importantly, we achieved the most significant milestone in the history of our organization, FDA approval of an investigational device exemption (IDE) that allows us to initiate the first human Hemopurifier® therapy studies in the United States. As a result, we have an opportunity to reward our stakeholders though the established Wall Street model of demonstrating U.S. clinical progression. For those not familiar with our Hemopurifier®, it is a first-in-class medical device that targets the rapid elimination of life-threatening infectious viruses and cancer glycopathogens from circulation.
As per the IDE approved protocol, we will enroll ten end-stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the protocol, which we previously conducted with success in India, will set the stage for pivotal studies required for market clearance in the U.S. The approval of our IDE has also unlocked the ability to advance clinical partnering programs with medical institutes that are pursuing indications of our Hemopurifier® in cancer care.
Manufacturing Optimization and Ramp-up
In the coming weeks, we are scheduled to initiate Hemopurifier® manufacturing to support our FDA approved study as well as our continued treatment endeavors overseas. In this regard, I am pleased to share that our researchers along with collaborative assistance have discovered a processing technique that significantly optimizes the ability of the affinity agent immobilized within the Hemopurifier® to bind viruses and other glycopathogen targets. As you may recall, we previously reported that intermittent Hemopurifier® administration during the first three days of interferon-based therapy resulted in undetectable viral load in as little as seven days in hard-to-treat HCV genotype-1 patients. Based on a review of clinical literature, we believe such outcomes reflect a significant advancement in HCV care. By incorporating our new processing techniques into our manufacturing protocol, we expect the optimized capture capabilities of the Hemopurifier® will further augment the benefit of standard-of-care drug therapies. We anticipate Hemopurifier® manufacturing to be complete by year-end and then expect to begin treating patients in the first quarter of 2014.
Exosome Sciences Follow-up
Last month, we announced the launch of Exosome Sciences (ESI) as a subsidiary that is advancing exosome-based strategies to diagnose and monitor the progression of cancer, infectious disease and other life-threatening conditions. We also disclosed that we staffed ESI with two of the best-known thought leaders in the exosome industry.
Additionally, we referenced a plan to establish the ESI labs in a research facility located in Langhorne, Pennsylvania. We reconsidered the Langhorne option and instead made the decision to execute a lease and are now building out ESI lab facilities at the Princeton Research Center (www.princetoncorporateplaza.com). This 260,000 square foot facility is ideally situated on the Princeton-Rutgers Route 1 Corridor (“Einstein Alley”), which provides easy access to both New York City and Philadelphia. We are planning a small grand opening event for Aethlon shareholders in early November and will let you know once a date has been set. Regardless, our goal is to transform ESI from a previously unvalued asset into a stand-alone organization that contributes measurable asset value on the balance sheet of Aethlon Medical.
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
SOURCE Aethlon Medical, Inc.