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Monday January 29, 8:59 am Eastern Time
Press Release
Hemispherx Biopharma Introduces a New `Strategic Treatment Intervention` (STI) Clinical Approach to Enhance Immunity Against HIV
PHILADELPHIA--(BUSINESS WIRE)--Jan. 29, 2001--Hemispherx Biopharma, Inc. (AMEX: HEB; HEBws) announced today a major amendment in a recent FDA authorized Phase II protocol designed to accelerate immunologic gains in patients receiving intensified antiviral therapy for HIV disease. The objectives of the new protocol are three fold:
Create optimal conditions for antiviral effectiveness (termed ``HAART``)
Encourage immune reconstitutions
Minimize HAART toxicity
At the International DART 2000 HIV Conference in San Juan, Puerto Rico, December 20, 2000, an urgent need for successful STI was announced with a goal of decreasing HAART toxicities and, at the same time, stimulating durable HIV specific immunity. The problem was summarized in layman`s terms in the January 21, 2001, 60 Minutes feature broadcast titled ``Nothing More to Worry About?``
According to DART 2000 sources, more than 50% of AIDS deaths in the United States may now be due to HIV drug toxicities, especially cumulative liver toxicities. Also current estimates indicate that it would require 60 years of treatment to eliminate HIV from the infected patient by using HAART alone without immune support.
In the new Hemispherx protocol, the investigational immunotherapeutic, Ampligen®, will be provided constantly, while the HAART regimen will be used periodically to result in superb HIV suppression.
The ultimate goal of STI is to induce chronic immune control of HIV, thereby eliminating the need for life long HAART.
Researchers at the Harvard Medical School recently tested the immune-based treatment hypothesis. They found no evidence of residual virus in some patients on the small pilot study (Nature 407:523, 2000) using the Massachusetts General Hospital. By contrast, the comprehensive Hemispherx clinical program will involve more than 100 patients and will be conducted nationwide.
Information contained in this news release other than historical information, including the referenced Phase Strategic Intervention, the associated laboratory results and the resultant clinical initiatives, should all be considered forward-looking and are subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes 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. Accordingly, actual results may differ materially from those in any forward looking statements. Additionally, all the referenced investigational drugs and associated technologies of the company 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 judgement as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
--------------------------------------------------------------------------------
Contact:
Hemispherx Biopharma, Inc., Philadelphia
William A. Carter, M.D., 215/988-0080
Dianne Will, 518/398-6222
Fax: 518/398-6223
Mark Kollar, 212/232-2222
Fax: (212) 232-3232
HEB`s Web Site: www.hemispherx.net
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More Quotes and News: Hemispherx Biopharma, Inc (AMEX:HEB - news)
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Press Release
Hemispherx Biopharma Introduces a New `Strategic Treatment Intervention` (STI) Clinical Approach to Enhance Immunity Against HIV
PHILADELPHIA--(BUSINESS WIRE)--Jan. 29, 2001--Hemispherx Biopharma, Inc. (AMEX: HEB; HEBws) announced today a major amendment in a recent FDA authorized Phase II protocol designed to accelerate immunologic gains in patients receiving intensified antiviral therapy for HIV disease. The objectives of the new protocol are three fold:
Create optimal conditions for antiviral effectiveness (termed ``HAART``)
Encourage immune reconstitutions
Minimize HAART toxicity
At the International DART 2000 HIV Conference in San Juan, Puerto Rico, December 20, 2000, an urgent need for successful STI was announced with a goal of decreasing HAART toxicities and, at the same time, stimulating durable HIV specific immunity. The problem was summarized in layman`s terms in the January 21, 2001, 60 Minutes feature broadcast titled ``Nothing More to Worry About?``
According to DART 2000 sources, more than 50% of AIDS deaths in the United States may now be due to HIV drug toxicities, especially cumulative liver toxicities. Also current estimates indicate that it would require 60 years of treatment to eliminate HIV from the infected patient by using HAART alone without immune support.
In the new Hemispherx protocol, the investigational immunotherapeutic, Ampligen®, will be provided constantly, while the HAART regimen will be used periodically to result in superb HIV suppression.
The ultimate goal of STI is to induce chronic immune control of HIV, thereby eliminating the need for life long HAART.
Researchers at the Harvard Medical School recently tested the immune-based treatment hypothesis. They found no evidence of residual virus in some patients on the small pilot study (Nature 407:523, 2000) using the Massachusetts General Hospital. By contrast, the comprehensive Hemispherx clinical program will involve more than 100 patients and will be conducted nationwide.
Information contained in this news release other than historical information, including the referenced Phase Strategic Intervention, the associated laboratory results and the resultant clinical initiatives, should all be considered forward-looking and are subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes 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. Accordingly, actual results may differ materially from those in any forward looking statements. Additionally, all the referenced investigational drugs and associated technologies of the company 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 judgement as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
--------------------------------------------------------------------------------
Contact:
Hemispherx Biopharma, Inc., Philadelphia
William A. Carter, M.D., 215/988-0080
Dianne Will, 518/398-6222
Fax: 518/398-6223
Mark Kollar, 212/232-2222
Fax: (212) 232-3232
HEB`s Web Site: www.hemispherx.net
Email this story - Most-emailed articles - Most-viewed articles
--------------------------------------------------------------------------------
More Quotes and News: Hemispherx Biopharma, Inc (AMEX:HEB - news)
Related News Categories: biotech, health care, medical/pharmaceutical
Hemispherx könnte demnächst interessant werden:
Neben den aktuellen klin. Studien bzgl. HIV gibts neue Resultate zu den CFS-Studien. Positive Resultate.
Außerdem soll es am Montag eine Analystenkonferenz (in USA) geben, zumindest so ich es einem der Poster
am Yahoo-Board glauben darf.
Götz
Neben den aktuellen klin. Studien bzgl. HIV gibts neue Resultate zu den CFS-Studien. Positive Resultate.
Außerdem soll es am Montag eine Analystenkonferenz (in USA) geben, zumindest so ich es einem der Poster
am Yahoo-Board glauben darf.
Götz
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