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Symbol: OTCBB: AEMD

Sector: Biotech / Pharma

Website: aethlonmedical.com

SEC Filings: details


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OTCBB:AEMD slide show / media
A Novel Therapeutic Strategy to Address Cancer
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About Aethlon Medical

At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.

Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.

Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.

As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:

  1. Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
  2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
  3. Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
  4. Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.

The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.

In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.

Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.

 

Products

Hemopurifier®

The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.

In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 min.

Highlights of the Hemopurifier®

  • Multi-patented first-in-class medical device to selectively capture viruses and immunosuppressive toxins from the entire circulatory system
  • Preserves immune cells needed to combat cancer and viral infections
  • Inhibits viral replication by clearing viruses prior to cell and organ infection
  • Provides expansive treatment pipeline into both cancer and infectious disease
  • Establishes first therapeutic strategy to address the immunosuppression caused by cancer
  • Safety of the device has been demonstrated in human studies
  • Significant reduction of viral load demonstrated in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients
  • Demonstrated improved immune function of HIV patient clinically defined with AIDS
  • Near-term commercialization strategy established in India
  • Investigational device exemption (IDE) on file with FDA
  • GMP manufacturing has been established
  • Positioned as an adjunct to accelerate the benefit of HCV drug regimens
  • Provides candidate treatment solution for drug resistant HIV/AIDS patients
  • Leading broad-spectrum countermeasure against bioterror and pandemic threats
  • Treatment mechanism is being leveraged to create high-sensitivity diagnostic and biomarker discovery productsutes.

 

Executive Team

James A. Joyce

Chairman and Chief Executive Officer

James A. Joyce founded Aethlon Medical in May 1998, and presently serves as Chairman, President and Chief Executive Officer. During Mr. Joyce's tenure, Aethlon has evolved the concept of a medical device to treat infectious disease into a reality of treating infected patients in a clinical trial environment. The resulting Hemopurifier® technology is positioned to treat global pandemic issues such as HIV/AIDS, Hepatitis-C, and pathogens most likely to be weaponized for use in bioterrorism. Mr. Joyce has been an active participant in the emerging biodefense industry. He has testified before Congress on issues related to Project BioShield legislation and the deployment of the Hemopurifier as a countermeasure against biological weapons. His efforts have been instrumental in expanding the definition of treatment countermeasure in Project BioShield legislation to include medical devices. Mr. Joyce recently served on the Project BioShield panel at the Federal Biodefense Research Conference, and was named Co-Chairman of the Bioterrorism/Chemical and Nuclear Security Task Force of the Homeland Security Industries Association. Mr. Joyce actively discusses issues related to infectious disease at various conferences, and has been featured in news stories on CNN, NBC, ABC, and other media outlets. From February 1993 until founding Aethlon Medical, Mr. Joyce was Chief Executive Officer of James Joyce & Associates. Previously, he was founder and Chief Executive Officer of Mission Labs, Inc., was a principal at London Zurich Securities, Inc., and played professional football for the Denver Broncos of the National Football League. Mr. Joyce is a graduate of the University of Maryland.

Rodney S. Kenley

President

Mr. Kenley has 33 years of experience in healthcare, most of which have been spent in the extracorporeal blood purification arena. Mr. Kenley held several positions at Baxter Healthcare (Travenol) from 1977 through 1990 including International Marketing Manager, Business Unit Manager for Peritoneal and Hemodialysis products, Manager of New Business Development, Director of Worldwide Product Planning, Director of Advanced Product Development, and VP of Electronic Drug Infusion. During this tenure he conceived of and managed the launch of several new products that have been highly commercially successful including the HomeChoice peritoneal dialysis cycler.

Mr. Kenley founded Aksys Ltd. in January 1991 to develop and commercialize his concept of a daily home hemodialysis system which was commercially launched in 2002 as the PHD system. In 2004, Mr. Kenley initiated the development of a second-generation home hemodialysis system in partnership with DEKA Research & Development Corporation in Manchester, New Hampshire. In 2007, the assets of Aksys Ltd. were acquired by DEKA, where Mr. Kenley was employed prior to joining Aethlon.

Mr. Kenley is the recipient of over 30 patents and has been a frequent presenter at international symposia regarding the provision of dialysis, the design of dialysis equipment, designing medical equipment according to FDA guidelines as well as lecturing at the Kellogg School of Management at Northwestern University and at other business schools in the area of entrepreneurship.

Mr. Kenley received his Bachelor of Arts degree in Biology and Chemistry from Wabash College, a Masters of Science degree in Molecular Biology from Northwestern University and a Masters of Management from the Kellogg School of Management, also at Northwestern University.

James B. Frakes

Chief Financial Officer

Mr. Frakes joined Aethlon Medical in January 2008 and brought 16 consecutive years of financial responsibility for publicly traded companies, as well as, specific knowledge and experience in equity and debt transactions, acquisitions, public reporting and Sarbanes-Oxley section 404 internal control requirements. He previously served as the CFO for Left Behind Games Inc., a start-up video game company. Prior to 2006, he served as CFO of NTN Buzztime, Inc., an interactive entertainment company with $40 million in sales, where he played a key role in acquisitions that doubled the company's revenue.

Mr. Frakes received an MBA from the University of Southern California, and completed his BA with Honors at Stanford University.

Richard H. Tullis, Ph.D.

Senior Vice President, Chief Science Officer

Dr. Tullis has extensive biotechnology management and research experience, and is the founder of Syngen Research, a wholly-owned subsidiary of Aethlon Medical, Inc. Dr. Tullis became a Vice President and Director of Aethlon Medical, Inc. in January of 2000, and succeeded Dr. Clara M. Ambrus as Chief Scientific Officer in June of 2001. Previously, Dr. Tullis co-founded Molecular Biosystems, Inc., a former NYSE company. At Molecular Biosystems, Dr. Tullis was Director of Research and Development, Director of Oligonucleotide Hybridization, Senior Research Scientist and Member of the Board of Directors. In research, Dr. Tullis developed and patented the first application of oligonucleotides to antisense antibiotics and developed new methods for the chemical synthesis of DNA via methoxy-phosphorochloridites. Dr. Tullis also co-developed the first applications of covalently coupled DNA-enzyme conjugates using synthetic oligonucleotides during his tenure at Molecular Biosystems. In 1985, Dr. Tullis founded, and served as President and CEO of Synthetic Genetics, Inc., a pioneer in custom DNA synthesis, which was sold to Molecular Biology Resources in 1991. Dr. Tullis also served as interim-CEO of Genetic Vectors, Inc., which completed its IPO under his management, and was co-founder of DNA Sciences, Inc., a company that was eventually acquired by Genetic Vectors. Dr Tullis received his Ph.D. in Biochemistry and Cell Biology from the University of California at San Diego, and has done extensive post-doctoral work at UCSD, USC, and The Scripps Research Institute.

 

Contacts

James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com

John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com

 

News for Aethlon Medical, Inc.:

 

Media Link:

SeeThruEquity Issues Company Note on Aethlon Medical's First Treatment of Ebola Patient and Raises Target Price to $0.74 - November 18, 2014

These Medical Stocks Are Reaching A Fever Pitch Following Midterm Elections - November 12, 2014

Ebola Could Offer Significant Opportunity for AEMD - October 14, 2014

Aethlon Medical's OTC shares surge on use of device in Ebola treatment - October 14, 2014

Wocket quiere publicar tus fotos en competencia "Muéstranos tu billetera" - August 20, 2014

AEMD: Q1 Update, Revived Attention on Ebola - August 20, 2014

AEMD Further De-Risks Balance Sheet - July 16, 2014

Companies Chasing Gold Nugget of Immuno-Oncology Like Never Before - June 26, 2014

AEMD: Cancer Gaining More Traction As Target for Hemopurifier - May 29, 2014

Exosomes Common Link in Cancer Drug Development - May 15, 2014

Are Exosomes the Next PD-1 in Cancer Research? - April 30, 2014

Exosomes Shine a Light on Alzheimer’s Disease and CTE April 3, 2014

Breakthroughs on the Horizon for CTE and Other Neurodegenerative Diseases - March 13, 2014

Discovery Could Lead to Major Breakthrough in Alzheimer's Disease and Other Brain Disorders - March 5, 2014

Aethlon Medical Expands Clinical Network Through DaVita Agreement - February 26, 2014

Invest in Exosomes Before Wall Street Does - wallstcheatsheet.com - December 31, 2013

AEMD: DARPA Picks Up Year-3 Option October 2, 2013

DARPA project aims to conquer blood disease August 23, 2013

AEMD: Remain Encouraged By Ongoing Progress August 19, 2013

Technical Stock Chart Analysis of Breakout Medical Device Company August 6, 2013

Aethlon Medical, Inc. (AEMD) Featured in Seeking Alpha article Plenty Of Room For Everyone In The Race To FDA Approval For New Hepatitis C Therapies July 23, 2013
includes: ABBV, BMY, ENTA, GILD, JNJ

Hemopurifier to be Studied as Treatment Option for Hepatitis C June 26, 2013 - Medgadget.com
Hemopurifier Hemopurifier to be Studied as Treatment Option for Hepatitis C Aethlon Medical out of San Diego, CA has been investigating its Hemopurifier extracorporeal blood filtration device that has the potential to help manage a number of infectious diseases, as well as remove tumor-derived exosomes related to certain cancers.

FDA Approves Aethlon Medical Device for Clinical Testing June 26, 2013 - San Diego Business Journal
The U.S. Food and Drug Administration has approved for clinical testing a blood purification device developed by San Diego-based biotech Aethlon Medical Inc.

FDA approves human feasibility study of device for treatment of HCV June 25, 2013 - Healio.com
The FDA has approved an investigational device exemption for a human feasibility study of a medical device for treating patients with hepatitis C, according to a press release.

New IDE for Medical Device, Hepatitis C Investors to Ponder June 25, 2013 - AccessWire
Aethlon Receives IDE Approval from FDA, Clears Way for Clinical Trials of New Hepatitis C Therapy

FDA Approves Human Study With Hemopurifier June 25, 2013 - By Zacks Small Cap Research

AEMD's Positive Recent Developments June 3, 2013

WellCare to join Georgia TeleHealth March 7, 2013

How Cancer Beats the Immune System March 7, 2013

Humana Reiterated Neutral March 6, 2013

REIT Companies Join to Webcast Live for Special March 7th RetailInvestorConferences.com Event March 5, 2013

Are Exosomes the Key to Stopping the Spread of Cancer? February 27, 2013

AEMD: DAPRA Revenue, Operational Progress Continues - February 14, 2013
By Zacks Equity Research

IDE Submitted Seeking Approval of U.S. Feasibility Study - January 3, 2013
By Zacks Equity Research

Aethlon's Non-Toxic Hepatitis C Approach Affirmed As Another Drug Trial Halted - August 20, 2012

AEMD Looking At Melanoma- June 13, 2012
By Zacks Small Cap Research

Our baby done growed up: Aethlon books first revenues ever on DARPA deal
November 17, 2011
By MassDevice staffAethlon Medical books its first revenues ever, on a payment from its $6.8 million contract with the Defense Advanced Research Projects Agency to develop its Adapt blood filtration system for treating service members with combat injuries.

Aethlon Medical receives $6.8M DARPA contract, Sand Diego Source - October 3, 2011
By Daily Transcript staff report

Aethlon Medical Inc. (OTCBB: AEMD), a developer of therapeutic filtration devices, has been awarded a $6.8 million contract from the Defense Advanced Research Projects Agency (DARPA) to develop a therapeutic device to reduce the incidence of sepsis, a fatal bloodstream infection that is often the cause of death in combat-injured soldiers.

The contract program will utilize the Aethlon ADAPT system as a core technology component underlying an extracorporeal blood purification device that selectively clears multiple sepsis-enabling particles from circulation to promote recovery and prevent sepsis. The resulting device, which is being advanced under DARPA's Dialysis Like Therapeutics (DLT) program, is expected to dramatically decrease the morbidity and mortality of sepsis.

Under the DLT program, Aethlon will also introduce a novel blood pump strategy to reduce or eliminate the systemic administration of anticoagulants normally required during extracorporeal device therapies. Worldwide, more than 18 million cases of sepsis are reported every year, with more than six million resulting in death.

The Aethlon award from DARPA is a fixed-price. five-year contract valued at $6,794,389 with year one revenues of approximately $2 million.

Aethlon Medical, Inc. (OTCBB: AEMD) featured in Medical Design Online - September 21, 2011

San Diego Source - August 25, 2011
Aethlon Medical Inc.: Company announced it has entered into an agreement with the Sarcoma Oncology Center to study the effectiveness of the Aethlon Hemopurifier to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients.

Aethlon Medical Ramping Up Activities in 2011; Redcip.com blog

Aethlon Medical Announces Multi-Target Exosome Assay Validation - April 15, 2011

 

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