Biotech/Pharma Stocks: (OTCBB: AEMD), (NYSE: MRK), (VRTX) Progress on Potential New Treatments for Hepatitis C Virus (HCV)
Aethlon Medical, Inc. (OTCBB: AEMD), Vertex Pharmaceuticals Inc (VRTX), Merck & Company, Inc. (NYSE: MRK) FDA Progress with Hepatitis C Virus (HCV) Treatments
Point Roberts, WA- May 13 2011- Investorideas.com. a leader in sector stock research including biotech and pharma stocks issues a sector snapshot of three companies, Aethlon Medical, Inc. (OTCBB: AEMD), Vertex Pharmaceuticals Inc (VRTX)., Merck & Company, Inc.(NYSE: MRK ) and their developments and progress for the treatment of Hepatitis C Virus (HCV).
Aethlon Medical, Inc. (OTCBB: AEMD) trading at $0.1030, up 0.0040 (4.04%)
Merck & Company, Inc. (NYSE: MRK ) trading at$37.08, down 0.12 (0.32%)
Vertex Pharmaceuticals Inc (VRTX ) trading at $57.30, down 0.71 (1.22%)
Aethlon Medical, Inc. (OTCBB: AEMD) recently announces that it has submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States. As part of these discussions, Aethlon management will present FDA officials with new clinical data that supports the safety of the Hemopurifier® and demonstrates the capability of the medical device to reduce viral load in individuals infected with the hepatitis C virus (HCV). Based on the data to be presented, Aethlon will request permission to expand the target treatment indications of the Hemopurifier® to include HCV in the U.S. At present, the treatment indication underlying the Aethlon IDE is solely directed toward the use of the Hemopurifier® as a countermeasure against bioterror and pandemic threats.
Vertex Pharmaceuticals Inc (VRTX ) reported in its May 3rd update that they intend to use the name INCIVEK (in-SEE-veck) as the trade name for telaprevir. If approved, telaprevir will be marketed by Vertex as INCIVEK in the U.S. Vertex recently completed its FDA Antiviral Drugs Advisory Committee meeting for INCIVEK (telaprevir). At the conclusion of the meeting, the committee voted unanimously (18-0) to recommend FDA approval of INCIVEK (telaprevir) for people with genotype 1 chronic hepatitis C who were not treated previously and those who were treated previously but not cured with currently available medicines. Vertex expects the FDA to provide its formal decision on the New Drug Application for INCIVEK (telaprevir) by May 23.
Merck & Company, Inc.(NYSE: MRK ) reported April 27th, that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously that the available data support approval of Merck's investigational medicine VICTRELIS™ (boceprevir) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection in combination with current standard therapy. VICTRELIS is one of a new class of medicines known as HCV protease inhibitors being evaluated by the FDA for the treatment of chronic HCV genotype 1 infection in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
The committee's recommendation will be considered by the FDA in its review of the New Drug Application for VICTRELIS. The FDA is not bound by the committee's guidance, but takes its advice into consideration when reviewing investigational medicines. The company anticipates FDA action on VICTRELIS by mid-May.
Structure of the IRES located in the 5'-UTR of HCV
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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 aethlonmedical.com.
James A. Joyce
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