class action lawsuit against Hemispherx (ampligen makers)

[leelaplay]

Co-cure sent this out today. It won't help ampligen at all.


Dyer & Berens LLP files class action lawsuit against Hemispherx Inc.[/URL] - HEB Marketwire October 10, 2009

The complaint alleges that, during the Class Period, defendants
misled investors regarding the status of Hemispherx's New Drug
Application ("NDA") for Ampligen with the U.S. Food and Drug
Administration ("FDA"). Specifically, defendants failed to disclose
and misrepresented the fact that the FDA had requested several
reports from the Company before the NDA could even be considered,
thus delaying the possible approval of Ampligen by several months
at a minimum. On November 2, 2009, when the Company belatedly
disclosed this information, the per share price of Hemispherx's
common stock dropped from $1.45 on the previous day to $1.13, a
drop of more than 20%. The next day, one commenter characterized
the November 2nd Company "update" as essentially an admission
"that its prior public statements were false and misleading."

islandfinn

 

[dannybex]

I knew this would happen...

I've read about stockholders being extremely upset with the CEO...how he basically withheld information back in June, and also lied, saying the FDA approval would happen within 2 months -- a tactic which some claim was used solely to drive up the price of the stock, which worked: The stock price rose to something like $4.20 a share...and is now down at $1.20-ish. In the meantime, almost six months later, and they finally admit that the FDA needed more information all along. It never was going to be approved months ago.

There were also allegations that he (or the company) deliberately lied about the phase 3 test results, as the percentages kept changing from the first press release to later ones.

Amazing that Carter has not run the company completely into the ground. It's no wonder that Ampligen has been around for 30-35 years, yet never been approved by the FDA...

d.

p.s. Island Finn...the link didn't work...at least on my 'puter.

 

[starryeyes]

From what I know of Ampligen, it makes some PWC feel better but they have to stay on it forever and it makes others much worse, permanently. That's why I think the FDA hasn't approved it.

Hemispherx Biopharma did say that they were squeezed out of the last meeting by big pharma that could pay more for the better seats.

I liked reading this:

Hemispherx Biopharma, Inc. Updates Chronic Fatigue Syndrome (CFS) Treatment
Monday, 2 Nov 2009 08:45am EST

Hemispherx Biopharma, Inc. announced a two-prong Chronic Fatigue Syndrome (CFS) clinical mission for November and December 2009. The Company plans to widen its ongoing clinical programs in CFS by accelerating collaborations with a consortium of researchers who have just discovered a retroviral link to Chronic Fatigue Syndrome. A clinically validated test to detect retrovirus antibodies in patients plasma is also currently under development. With the consortium of researchers at the Whittemore Peterson Institute, the Company is also now evaluating the defect in immunosurveillance in specific subsets of CFS patients in a clinical study entitled Therapeutic Activation of NK lymphocytes to Alleviate Chronic Fatigue Syndrome. These immune defects may be due to the previously undetected retrovirus.

Hemispherx Biopharma, Inc. Announces New Infectious Retrovirus Detected In Chronic Fatigue Syndrome
Tuesday, 13 Oct 2009 08:16am EDT

Hemispherx Biopharma, Inc. announced that the discovery of a retrovirus in CFS may now shed new light on the potential mechanism of action of Ampligen (Poly I: Poly C12U), an experimental therapeutic, in CFS. CFS is a debilitating disease of unknown etiology that is estimated to affect 17 million people worldwide. In the October 8, 2009 issue of Science Express, a consortium of researchers from the Whittemore Peterson Institute, the National Cancer Institute and the Cleveland Clinic report a new retrovirus in the blood cells of 67% of Chronic Fatigue Syndrome (CFS) patients and 3.7% in healthy control subjects. The infectious virus was also greater than 99% identical to that previously detected in prostate cancer. Patients with CFS are known to display various abnormalities in immune system functions and experience both higher cancer rates and neurological pathology, all of which may be associated with several retroviruses such as HIV and HTLV-1. Presently, the Company is actively collaborating with the Whittemore Peterson Institute to evaluate the potential role of Ampligen, an experimental therapeutic, in the clinical treatment of CFS patients who have a specific deficiency in Natural Killer (NK) cell activity.

Hemispherx Biopharma, Inc. Presents New Data On Immuno-Potential Of Hemispherx's Ampligen
Friday, 2 Oct 2009 08:46am EDT

Hemispherx Biopharma, Inc. announced that Dr. Jonathan S. Berek, Professor and Chair, Obstetrics and Gynecology, Stanford University School of Medicine, presented new data on Ampligen (Poly I : Poly C12U) at the Pacific Coast Oncology Gynecology Society Meeting, La Jolla, California, on October 1, 2009. The paper, entitled 'Enhancing Dendritic Cell (DC) and Antibody Immunotherapy with Toll Receptor (TLR Agonists),' discusses the incorporation of a periodic 'danger signal' into treatment regimens with a TLR3 agonist such as Poly I : Poly C12U and suggests such regimens may have broad potential application to boost the effects of immunotherapies of cancer. Ampligen (Poly I : Poly C12U), an experimental immunotherapeutic, is also being actively pursued as a pandemic influenza vaccine enhancer (Japanese National Institute of Infectious Diseases) and as potential monotherapy for chronic fatigue syndrome (CFS), in which the Company has a commercial application (NDA, new drug application) submitted and under review.

http://www.reuters.com/finance/stocks/keyDevelopments?rpc=66&symbol=HEB&timestamp=20091110225500

 

[dannybex]

Another article...

Quoting:

"While delays are a normal part of the long and difficult process of getting a drug approved, what the market is punishing Hemispherx for, and rightly so, is the fact that the company had previously made statements that appeared to support the idea that the drug would win a marketing license in May, rather than the truth that its NDA filing was incomplete. What has added insult to injury is that Hemispherx took the opportunity to raise money not once but twice in May, bagging $34.4 million after the shares more than doubled as investors became increasingly excited as the PDUFA decision approached (Event - Hemispherx shares liven up ahead of chronic fatigue drug PDUFA date May 19, 2009).

Confession Good for the Soul, Not the Shares

After a wait of almost six months, the group has finally and formally informed the market that there are outstanding matters, including manufacturing issues, that it needs to sort out before there is any hope of approval.

Given the nature of the issues it is clear that these would have existed as the group was approaching the May PDUFA date, making the chances of approval almost non-existent, a material event that the Hemispherx management team neglected to mention. In fact, the group issued a statement on May 26 claiming that approval would only be delayed by one to two weeks.

However, since May there has been some impressive back peddling, and in August the group gave the first indication that all was not rosy in the garden, after it admitted it was working with its contract manufacturer, Hollister-Stier Laboratories, to sort out problems in the final part of the manufacturing process, which are now expected to be completed by the end of 2009."

http://seekingalpha.com/article/172...ma-investors-growing-tired-of-cfs-drug-delays

 

[Solon]

Can someone explain how this drug is supposed to work?? Ok it might shift TH1/TH2 response somehow back to normal, but what does it do with CD4 cells, what with NK cells and what with the rest?? I have low B cells low CD4, and normal NK and CD8, would that particular drug help me??