Aethlon Medical (AEMD) Note: Clinical Partnering Programs, Manufacturing Optimization and Ramp-Up, Exosome Sciences Grand Opening
Aethlon Medical, Inc. , 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 . 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.