Q: Investorideas.com
Jim can you tell us what the significance of the recent FDA approval is to Aethlon and a short synopsis of the road taken to get here?
A: James A. Joyce, Chairman, CEO of Aethlon Medical, Inc.
In regards to significance, our Hemopurifier® is the first medical device of its kind to be cleared by FDA for human studies in the United States. Based on previous treatment outcomes, our initial target is the elimination of circulating Hepatitis C virus. As we advance clinically, we plan to expand the indications for our Hemopurifier into other infectious disease and cancer targets. Regarding the road to get here? This all started out as a theoretical concept of a device that could selectively eliminate a broad-spectrum of disease targets from the entire circulatory system. With the approval from FDA to start U.S. studies, we are taking a major step toward turning our original vision into a reality.
Q: Investorideas.com
Can you explain the steps and timeline for the first feasibility study?
A: James A. Joyce, Chairman, CEO of Aethlon Medical, Inc.
We expect the study to kick-off toward year-end with completion expected toward the end of Q1 or early Q2 of 2014. We are now preparing for a manufacturing run to support our studies here in the U.S. as well as a compassionate-use program that has been established in India.
Q: Investorideas.com
Separate from Hepatitis C virus (HCV), what other diseases can be potentially be targeted?
A: James A. Joyce, Chairman, CEO of Aethlon Medical, Inc.
Well, we conducted a successful proof of principal study in a HIV-AIDS patient and have also had leading government and non-government researchers conduct studies to validate the broad-spectrum capabilities of the Hemopurifier against numerous bioterror and pandemic threats. However, outside of HCV we are most excited about the discovery that the Hemopurifier® captures tumor-secreted exosomes underlying cancer. These particles contribute to establishing and spreading metastasis and they are extremely immunosuppressive. In fact, the quantity of exosomes in circulation is in direct correlation with stage of cancer. So, if you don’t have cancer, exosomes shouldn’t be present. However, if you have stage-four cancer, the quantity of circulating exosomes can be massive. We believe our Hemopurifier® is the first therapeutic candidate to address this vital target in cancer and because of our early work in the field, we already have a patent issued to protect our exosome related endeavors.
Q: Investorideas.com
Following completion of the feasibility study; what’s next?
A: James A. Joyce, Chairman, CEO of Aethlon Medical, Inc.
We would move quickly to collaborate with FDA to establish the treatment protocol for a pivotal study, which is required prior to commercial launch. Additionally, we would seek to leverage our feasibility data into other therapeutic targets.
Q: Investorideas.com
With current treatments available for Hepatitis C virus (HCV) patients; can you explain how the Hemopurifier® compliments drug regiments as well as addresses needs when resistance to drug regimens arises?
A: James A. Joyce, Chairman, CEO of Aethlon Medical, Inc.
Whether the treatment strategy is current interferon-based standard of care or emerging all-antivirals, our objective is to combine our Hemopurifier with therapy to accelerate the rate at which a patient first achieves undetectable HCV in circulation. In HCV care, the quicker an individual achieves undetectable viral load the higher the cure rate. As an example, only 11% of patients who initiate interferon-based therapy will achieve undetectable viral load at day 30 which is also known as a rapid viral response or RVR. Based on large-scale studies, RVR achievement equates to 86% cure rates versus less than 40% for non-RVR patients. We have demonstrated that a just a three treatment Hemopurifier® therapy regimen when administered to hard-to-treat HCV genotype 1 patients in combination with interferon-based therapy can achieve undetectable HCV in as little as seven days. We also envision that Hemopurifier® therapy will offer a solution to viral rebound patients who initially achieve undetectable viral load but then have the presence of virus reestablishing as a result of emerging drug resistance. This represents another opportunity for us to enhance the outcome of either all-antiviral or interferon-based therapies.
Q: Investorideas.com
The FDA news was a major milestone for the company and the Hemopurifier® but there are also major developments underway with the technology with Defense Advanced Research Projects Agency (DARPA). For new investors can you give them a brief outline where this stands?
A: James A. Joyce, Chairman, CEO of Aethlon Medical, Inc.
Sure, the technology platform underlying our Hemopurifier® is being utilized as the basis for a new device to treat sepsis, which is a leading cause of death in wounded warfighters and civilians in the ICU. In this regard, we were initially awarded a $6.8 million contract and then recently were part of a group that won a follow-on contract worth $22 million. We hope to be in a position to share some of our sepsis treatment advances in the near future.
Q: Investorideas.com
For a small medical technology company Aethlon Medical now has an impressive track record for its core technology. You have stayed the course over time, in spite of market conditions and having to fund the company in less than ideal times for small business. Can you tell us about the driving force behind that conviction?
A: James A. Joyce, Chairman, CEO of Aethlon Medical, Inc.
Getting to this point was hard. Think of the challenge. We were attempting to create a therapeutic mechanism that never previously existed and we would likely need to survive a decade or more without generating revenues in an industry where most therapeutic candidates never make it into human studies. However, when reflecting back, I could have never imagined that we would have the breadth of therapeutic opportunities that we have today in cancer, infectious disease and other life-threatening conditions.
About Aethlon Medical (OTCQB: AEMD)
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 DARPA to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
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