Point Roberts, WA - March 18, 2011- Investorideas.com releases an industry snapshot on HIV- AIDS drug makers and recent data that suggests the HIV virus has developed drug resistance and that drug industry is not acting fast enough to get new drugs into the pipeline to combat the potential threats.
Company snapshots include Gilead Sciences, Inc. (NasdaqGS: GILD), the largest player in HIV/AIDS products and medical technology companyAethlon Medical (OTCBB: AEMD).
Aethlon Medical (OTCBB: AEMD) is betting that its medical technology,
Hemopurifier® may offer solutions. Human studies have documented the ability of the 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.
"In the absence of a cure for AIDS, the drug industry responded with antiviral regimens that have allowed HIV-infected individuals the ability to effectively manage their disease," stated Jim Joyce, CEO at Aethlon Medical. "However, with a shrinking drug pipeline, the big question now is who is going to help these individuals at the point they become resistant to drug regimens?"
"Much like dialysis has extended the lives of those with kidney failure, we have created a therapeutic filtration device known as the Hemopurifier® that provides a device mechanism to address all circulating HIV strains, including those resistant to HIV drug therapies. Additionally, the device fills the unmet medical need of clearing immunosuppressive toxins that are shed by the virus to deplete immune cells, which is the hallmark of AIDS," concluded Joyce.
In the absence of drug therapy, Aethlon recently demonstrated immune function improvement and a greater than 90% viral load reduction in an AIDS patient as the result of 12 treatments administered over the course of one month.
UNAIDS recently reported in a press release, "Millions of people in developing countries now depend on a steady supply of affordable first-line treatment for HIV. If their treatment is interrupted, which can lead to drug resistance, these patients will have to switch to a second-line regimen. That can be at least six times more expensive than the first-line regimen," said Dr Gottfried Hirnschall, Director of WHO's HIV/AIDS Department.
A recent article on Bloomberg.com entitled , HIV Drug Development Falters as Merck, Bristol-Myers Struggle With Success" reports "Without a steady stream of new medicines to attack the virus in different ways, drug resistance will develop, leaving more patients without a viable treatment, said Scott Hammer, a professor of medicine at Columbia University in New York.
"If we are complacent, resistance will start to spread against the key components of our therapies," Hammer said in an interview. "We need to be ready for that because we won't be able to catch up after it happens."
Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is the first and only once-daily single tablet regimen for the treatment of HIV infection in adults. It is intended for use as a stand-alone therapy, or in combination with other antiretrovirals, and combines Gilead's Truvada® (emtricitabine and tenofovir disoproxil fumarate) with Sustiva® (efavirenz), manufactured by Bristol-Myers Squibb. ( U.S. approval, 2006; E.U. approval, 2007.)
Emtriva® (emtricitabine) is a once-daily oral nucleoside reverse transcriptase inhibitor (NRTI) used in combination with other antiretroviral agents for the treatment of HIV infection in adults. Emtriva is also available as an oral solution for use in pediatric patients. ( U.S. and E.U. approval, 2003.)
Truvada® (emtricitabine and tenofovir disoproxil fumarate) is a fixed-dose once-daily combination pill containing Viread® and Emtriva®. It is used in combination with other antiretroviral agents for the treatment of HIV infection in adults. ( U.S. approval, 2004; E.U. approval, 2005.)
Viread® (tenofovir disoproxil fumarate) is a once-daily oral nucleotide reverse transcriptase inhibitor (NtRTI) for the treatment of HIV infection in adults and adolescents in combination with other antiretroviral agents. ( U.S. approval, 2001; E.U. approval, 2002.) Viread® was also approved in 2008 as a treatment for chronic hepatitis B in adults. ( U.S. and EU approval, 2008.)
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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