Ampligen and WPI

[Solon]

As i mention many times, different co-infections affect our immune systems in different ways, dont bother believing that we all have the same immune profiles here.
I ve seen around 20 or more immune assays from alleged post viral CFS sufferers over the years, and i will try to find some to post, i didnt really care about collecting data so much in the past as i do now as i recognise the value nowadays.

Well there where people with EBV+CMV who had completely different picture from others who had just EBV, or CMV and HHV6 or some bacteria on top or lyme etc etc. Some even exhibit different symptomatology, especially the EBV group dont have much to do with CMV, but it all ended up to affect the stress system more or less and most symptoms correlate in the minds of patients but are in no way identical biochemically. We are talking about a vast array of different infections or coinfections that affect one same system here. The neuroimmune and endocrine axis. Some viruses get triggered by hormone ups and downs to keep reactivating like EBV, or HSV, or Enteroviruses or HHV6, others dont ever reactivate, or they do reactivate only when a new viral agent gets introduced. It could be very naive to think that one drug can help all, offcourse its very wishful.

 

[LaurelB]

My apologies if this has already been posted elsewhere:

http://www.earthtimes.org/articles/show/hemispherx-biopharma-to-present-at-the-rodman-healthcare-conference,1297660.shtml

LPHIA, May 13, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), today announced that the Company will participate in the Rodman & Renshaw 6th Annual Global Healthcare Conference to be held on May 16-18, 2010 at the Grosvenor House Hotel, London, UK. Dr. William A. Carter, Hemispherx's Chairman & CEO, is scheduled to present on Monday, May 17th, at 11:30 AM BST; 6:30 AM EDT.

Programs to launch Alferon N Phase II clinical trials and preparation for new clinical trials of Alferon LDO and Ampligen, both experimental therapeutics, will be described at this conference. Dr. Carter will discuss studies and activities planned for Southeast Asia, the Pacific Rim and South America. His presentation will include an update on the clinical trials for hospitalized flu patients in India which the company and Max Neeman are seeking approval to begin in June 2010, the Indian Monsoon season.

Dr. Carter will also provide an interim report on retrospective analyses of patient samples from the completed Phase III trial of Ampligen in potential treatment of Chronic Fatigue Syndrome ("CFS") conducted in collaboration with the Whittemore Peterson Institute; these studies are expected to provide a new perspective on the design of a confirmatory Phase III study in this disorder. The samples are being analyzed for the presence of XMRV, a novel retrovirus, reported to be found in approximately two-thirds of CFS patients.

The presentation will be Webcast live. Listeners can access this broadcast through Hemispherx`s Website at http://www.hemispherx.net. The webcast will be available for 30 days following the presentation.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx' flagship products include Alferon N Injection (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen and Alferon LDO. Ampligen represents experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx' platform technology includes agents for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection). 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 and Alferon 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. Clinical trials for other potential indications of the approved biologic Alferon N Injection do not imply that the product will ever be specifically approved commercially for these other treatment indications. Further, the commencement of clinical trials by Max Neeman in India is its target date but cannot be guaranteed due to a variety of risk factors outside of the parties control and should be regarded only as a forward looking estimate.

CONTACT: Hemispherx Biopharma, Inc.
Company/Investor Contact:
518-398-6222
ir@hemispherx.net

 

[oerganix]

Thanks Laurel. I think it's totally on topic to post it here. And here is the latest from WPI on the Ampligen study:

WPI describes how Ampligen boosts NK cell activity in XMRV-positive CFS patients' cells

by Isabel Barao-Silvestre, et al.
May 7, 2010


Following is the abstract of a research paper by a team of University of Nevada/Whittemore Peterson Institute researchers. The paper will be presented May 9 to immunologists gathered in Baltimore at Immunology 2010™ by UN/WPI lead author Isabel Barao-Silvestre.

[Note: Degranulation is release of microbe-toxic molecules from granules found inside some immune cells, including Natural Killer cells.] ______________________________________

Characterization of the therapeutic increases in Natural Killer (NK) activity of xenotropic murine leukemia virus-related virus (XMRV)-positive chronic fatigue syndrome (CFS) patients effected by poly (I): poly (C12U) (Ampligen) – Source: May 9 Presentation, Immunology 2010™

Chronic Fatigue Syndrome (CFS) is a debilitating disease of unknown etiology that affects ~17 million people worldwide. Patients suffer persistent viral infections and may develop hematopoietic malignancies. The patients have reduced Natural Killer (NK) cell activities which could contribute to the diseases, and, if restored, potentially reduce symptoms.

We characterized the in vitro effects on NK cells of the interferon inducer poly (I): poly (C12U) (Ampligen) which in some CFS patients abates disease symptoms.

The 30 CFS patients were infected with the gammaretrovirus xenotropic murine leukemia virus-related virus (XMRV).

We cultured their peripheral blood mononuclear cells with the drug for 24 hrs and monitor NK activity to K562 cells by flow cytometry, concurrently measuring degranulation by externalization of CD107a, and expression of Grz B and perforin.

Treatment markedly increased CD107a externalization in the NK cell population as indicated by 5-fold increases in CD107a-positive cell frequencies and 3-fold increases in their CD107a MFI, with slight positive shifts in intracellular Grz B and perforin.

In contrast, T cells showed little change in CD107a externalization.

Our results suggest that degranulation rates may be more affected than the levels of cytotoxic proteins, indicating a novel mechanism by which NK activity was affected by the drug.

The increase in degranulation per NK cell indicates a mechanism by which Ampligen treatment can improve NK cell function.

Source: Poster for May 9 presentation by Isabel Barao Silvestre at Immunology 2010™ in Baltimore, Maryland. Paper by Barao-Silvestre I, Marshall M, Hagen KS, Pfost MA, Strayer D, Peterson D, Hudig D, Mikovits JA. Whittemore Peterson Institute, Reno; University of Nevada, Reno, Nevada; Hemispherx Biopharma, Inc., Philadelphia, Pennsylvania, USA.