Multiple opportunities have recently surfaced for small organizations with innovative countermeasures against bioterror threats, and more are expected in the near future. As an example, Freemind Group, an industry advisory organization reported this week that they are witnessing a dramatic and unprecedented surge in biodefense and infectious disease funding opportunities from various government institutes. They anticipate that funding applications submitted during the coming months of May, June, and July alone will result in cumulative awards of approximately $500,000,000.00. In fact, some of these awards are not capped and can exceed $50,000,000 for clinical trial support. For small organizations, such non-dilutive awards offer to transform business capabilities and reward patient shareholders.
InvestorIdeas: That's certainly exciting, but how can small organizations like Aethlon Medical compete against big pharma for such awards?
Jim Joyce, CEO of Aethlon Medical
In reality, both big pharma and large biotechnology players have demonstrated little interest in responding to these programs. As a result, government agencies are primarily reliant on innovation stemming from research advanced by small organizations, which from a historical basis, is likely to be the principal source of innovation anyway. Still, these programs do not exist to solely support research. Recently created agencies like the Biomedical Research and Development Authority (known as BARDA) provide support for post R&D activities including clinical studies, manufacturing, and other activities that may be required to transition a candidate treatment countermeasure into the strategic national stockpile.
InvestorIdeas: Do you feel Aethlon Medical is positioned to benefit from these programs?
Mr. Joyce: I feel we are extremely well positioned to benefit as government policies to protect against bioterror and pandemic threats have been redefined to focus support towards broad-spectrum countermeasures that are able to address multiple pathogen threats. Based on pre-clinical and clinical data, we believe our Hemopurifier® is the most advanced and perhaps only true broad-spectrum countermeasure. While traditional therapeutics often struggle to address multiple strains of the same pathogen, third party researchers have demonstrated that our Hemopurifier® captures different species of many of the most deadly viral threats known to man. These include Dengue, Ebola, and Lassa Hemorrhagic Viruses, West Nile Virus, H5N1 Avian Influenza Virus, the 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918, and Monkeypox Virus, which is the primary model for testing treatments against human Smallpox infection.
InvestorIdeas: Have you conducted any human studies with your Hemopurifier®
Jim Joyce, CEO of Aethlon Medical
Yes, we have advanced our technology into human studies, which demonstrated safety and the observation of significant viral load reductions in both hepatitis-C and HIV infected individuals without the administration of antiviral drug therapies. We are now advancing a clinical program whose objective is to utilize our Hemopurifier® as an adjunct strategy to improve the benefit of hepatitis-C standard-of-care drug therapy without adding drug toxicity and interaction risks. We are quite excited about this clinical program, as therapeutic filtration of hepatitis-C from plasma has previously proven to have a remarkable effect in improving treatment outcomes when combined with drug therapy. Regardless, as it specifically relates to our biodefense opportunity, I feel confident that we are advancing a leading broad-spectrum therapeutic strategy to address viral threats, and that our strategy fulfills strategic objectives recently mandated by our government. We also benefit from a policy shift that no longer precludes the support of treatment countermeasures that may also have mainstream commercial market applications in disease conditions such as hepatitis-C, HIV, and cancer.
InvestorIdeas: Is Aethlon Medical currently pursuing any contract or grant opportunities?
Jim Joyce, CEO of Aethlon Medical
Yes. In the coming days we will submit a formal response to a military program opportunity entitled "Dialysis Like Therapeutics". The stated goal of this program is the creation of a medical device that would save the lives of thousands of military patients each year. While our response is challenging, it has also been rewarding as we have attracted several groups to partner and participate in our submission. Once our response is in, we will then convene with our advisors to determine the next contract opportunity to focus our efforts towards.
InvestorIdeas: In closing, is there any advice you would provide to other organizations that might be interested in participating in the biodefense and pandemic threat industry?
Jim Joyce, CEO of Aethlon Medical
By nature, the opportunity to address the looming threat of biological weapons and naturally emerging pandemic threats will be enduring and the industry is still very young. However, my advise for small organizations is to be sure they have therapeutic strategies in place to address established disease conditions with real commercial markets before venturing into a field where targeted disease conditions may or may not emerge and the primary source of support is government funding.
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.
Certain of the 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, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its 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.
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