POINT ROBERTS - November 28, 2011 - www.InvestorIdeas.com issues a biotech investor alert for Pharmasset, Inc. (Nasdaq:VRUS), Vertex Pharmaceuticals (VRTX) and Aethlon Medical, Inc. (OTCBB: AEMD), three stocks involved in the treatment of Hepatitis C Virus (HCV).
Over 170 million people worldwide are chronically infected with Hepatitis C. The sector made headlines earlier this week as Pharmasset, Inc. (Nasdaq:VRUS), traded up over 84% on acquisition news.
Gilead Sciences, Inc. (Nasdaq:GILD) and Pharmasset, Inc. (Nasdaq:VRUS) reported the companies have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash.
Pharmasset (Nasdaq:VRUS) has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company's lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog, has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients. Both studies will utilize 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial U.S. regulatory approval of PSI-7977 in 2014. PSI-938, an unpartnered guanosine nucleotide analog, is being tested in a Phase 2b interferon-free trial as monotherapy and in combination with PSI-7977 in subjects with HCV of all viral genotypes. Mericitabine (RG7128), a cytidine nucleoside analog, is partnered with Roche and is being evaluated in three Phase 2b trials. Roche is responsible for all aspects of the development of mericitabine.
Gilead's research and development portfolio includes seven unique molecules in various stages of clinical development for the treatment of HCV.
James A. Joyce, Chairman and CEO of Aethlon Medical, Inc. (OTCBB: AEMD) recently updated shareholders on November 16 th, "Our Hemopurifier® has demonstrated broad-spectrum capabilities against viral pathogens, including HCV, the human immunodeficiency virus (HIV), and a variety of tested bioterror and pandemic threats. Specific to treating HCV, we previously conducted studies that demonstrated the safe administration of our Hemopurifier® in HCV-infected dialysis patients whose average viral load reductions exceeded 50% during each four-hour treatment. These results were obtained in the absence of any drug therapy."
Vertex Pharmaceuticals Inc (VRTX ) announced earlier in November its interim results from ZENITH, an ongoing Phase 2 study designed to assess the safety, tolerability and efficacy of multiple 12- and 24-week response-guided treatment regimens with VX-222 (100mg or 400mg), its lead polymerase inhibitor in development, in combination with INCIVEK™ (telaprevir ) tablets, pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. On the basis of the results announced today and previously announced data from other treatment arms of the ZENITH study, Vertex intends to start a Phase 3 study to evaluate a total treatment duration of 12 weeks with this four-drug regimen in treatment naïve and relapser patients with genotype 1 chronic hepatitis C.
The Aethlon Medical mission is to create 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 therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
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