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Hemispherx (HEB)

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  1. [verwijderd] 20 juli 2011 15:28
    NEWS:

    July 20, 2011, 8:00 a.m. EDT

    FDA Authorizes New Hemispherx Biopharma Clinical Trial of Intranasal Ampligen(R) With Seasonal Influenza Vaccine
    First Clinical Application of Ampligen(R) Intranasally

    PHILADELPHIA, Jul 20, 2011 (GlobeNewswire via COMTEX) -- Hemispherx Biopharma, Inc. /quotes/zigman/165768/quotes/nls/heb HEB +8.03% (the "Company" or "Hemispherx") today announced it has received U.S. Food Drug Administration (FDA) authorization to proceed with the initiation of a new clinical trial of intranasal Ampligen(R) [rintatolimod; poly(I) * poly(C12,U)] used in conjunction with commercially approved seasonal influenza vaccine. The FDA authorization also requests that certain protocol amendments and pre-clinical items be filed to the Investigational New Drug (IND) Application; these requests are not expected to affect the implementation or timing of the clinical study which will involve healthy volunteers. The primary objective of this study is to evaluate the safety of three cycles of intranasal Ampligen(R) administered three days following each intranasal dose of seasonal influenza vaccine. Other objectives include evaluation of various immune responses to the trivalent seasonal influenza vaccine administered intranasally with and without Ampligen(R). Ampligen(R), a toll-like receptor 3 (TLR3) agonist, is an experimental therapeutic in advanced clinical development for the potential treatment of Chronic Fatigue Syndrome (CFS), an enigmatic disorder which may have certain viral "footprints".

    The initial studies for the influenza application were conducted at the Japanese National Institutes of Health (JNIH) and resulted in a series of peer-reviewed articles in the infectious diseases medical literature over the last several years.

    A similar study of Ampligen(R) and a seasonal influenza vaccine in mice resulted in cross-protection of the mice against a pandemic form of avian influenza (H5N1). Evidence for cross-reactivity against pandemic forms of avian H5N1 influenza virus will be investigated as one of the objectives of this study. One goal of this approach is to generate protective mucosal immunity against newly emerging strains of H5N1 with pandemic potential using Ampligen(R) as a mucosal adjuvant with trivalent seasonal influenza vaccine.

    About Hemispherx Biopharma

    Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) and Alferon(R) LDO. Ampligen(R) is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net .

    Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R) and Alferon(R) LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications.

    This news release was distributed by GlobeNewswire, www.globenewswire.com

    SOURCE: Hemispherx Biopharma, Inc.
  2. johnny baboa 28 augustus 2012 19:11
    quote:

    Bandito1983 schreef op 14 december 2010 15:30:

    [...]

    November 2010 - If you purchased or otherwise acquired Hemispherx Biopharma, Inc. (“Hemispherx”) common stock from February 18, 2009 through and including December 1, 2009, then you could receive a payment from the proposed Settlement of a securities class action lawsuit pending in Court.

    A Settlement has been proposed that will provide a settlement fund of $3.6 million in cash, plus interest (the “Settlement Fund”), to settle claims of investors who suffered damages from buying or otherwise acquiring Hemispherx common stock from February 18, 2009 through and including December 1, 2009. A hearing will be held on January 20, 2011 in Philadelphia, PA, to determine (1) whether the proposed Settlement (the "Settlement") of the above-captioned action ("Action") for $3,600,000 should be approved by the Court as fair, reasonable, and adequate; (2) whether the motion of Co-Lead Counsel for an award of attorneys' fees and reimbursement of expenses should be approved; and (3) whether the Action should be dismissed with prejudice.

    November 2009 - An investor in Hemispherx BioPharma, Inc (Public, AMEX:HEB) has filed a lawsuit in the United States District Court for the Eastern District of Pennsylvania on behalf of those who purchased the securities of Hemispherx Biopharma, Inc. (AMEX: HEB) between February 18, 2009 and October 30, 2009, over alleged violations of Federal Securities Laws.

    According to the complaint the plaintiff alleges that the defendants violated the federal securities laws by misleading investors regarding the status of Hemispherx's New Drug Application ("NDA") for its drug Ampligen with the U.S. Food and Drug Administration ("FDA"). Specifically, so the lawsuit, defendants failed to disclose that the FDA had requested several reports from Hemispherx Biopharma before the NDA could even be considered, thus delaying the possible approval of Ampligen by several months at a minimum. Then, on November 2, 2009, when Hemispherx Biopharma disclosed this information, the price of Hemispherx Biopharma securities (HEB) fell 20% to close at $1.13 on the next trading day, November 3, 2009.

    Hemispherx BioPharma, Inc said in a press release that it believes that the lawsuit is without merit and the fraud claim is irrefutably false.

    Hemispherx Biopharma, Inc., located inPhiladelphia, PA, is a biopharmaceutical company engaged in the clinical development, manufacture, marketing and distribution of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. The Company’s products include Ampligen and Alferon N and Injection. Hemispherx BioPharma, Inc reported in 2007 Total Revenue of $1.06million and in 2008 Total Revenue of $0.27million. Shares of Hemispherx BioPharma, Inc traded recently at $1.08 per share

    shareholdersfoundation.com/case/hemis...

    Deze bedoel ik , ik heb een cheque gekregen van 528.56 dollar [5000
    aandelen toen in mijn bezit]

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