Good interview.

New Hemispherx Prez Says Getting Ampligen Approval Top Priority -

See more at: http://simmaronresearch.com/2016/05/hemispherx-ampligen-approval-chronic-fatigue-syndrome-top-priority/#sthash.gZeuXQZ3.dpuf

#MillionsMissing announces US protest demands
http://www.meaction.net/2016/05/01/millionsmissings-protest-demands-available/

We demand the NIH immediately partner with the FDA to address the key obstacles to moving clinical trials forward. NIH must also actively incentivize pharmaceutical and biotech industries so that at least five accelerated clinical trials of medications are conducted over the next five years. The goal must be getting at least two FDA-approved medications on the market for ME/CFS patients in the next five years. Proposed medications include Ampligen,[iv] Rituxan[v] and antiviral medications,[vi] all drugs that have been in trials already and have been successfully used to treat ME/CFS patients.

I do too. We'll see what the 10-K says on their estimated timeline for the alferon plant. And the NIH study looks promising for ampligen, enrolling as soon as May - which for the NIH, is very quick.

Biospace News
March 11, 2016

New Hemispherx (HEB) CEO Will Not Receive Salary for Two Months Until Stock Performs Better
http://www.biospace.com/News/new-hemispherx-ceo-will-not-receive-salary-for-two/412027?source=sm&type=twitter_Hemispherx031115

Potential Diagnostic Biomarkers in Natural Killer (NK) Cells of Patients with Chronic Fatigue Syndrome (CFS)/ Myalgic Encephalomyelitis (ME).

New independent paper.

PLoS One. 2016 Mar 11;11(3):e0150904. doi: 10.1371/journal.pone.0150904.
MicroRNAs hsa-miR-99b, hsa-miR-330, hsa-miR-126 and hsa-miR-30c:
Potential Diagnostic Biomarkers in Natural Killer (NK) Cells of
Patients with Chronic Fatigue Syndrome (CFS)/ Myalgic
Encephalomyelitis (ME).
Petty RD, McCarthy NE, Le Dieu R, Kerr JR.

CONCLUSION: This study demonstrates altered microRNA expression in the peripheral blood mononuclear cells of CFS/ME patients, which are potential diagnostic biomarkers. The greatest degree of miRNA
deregulation was identified in NK cells with targets consistent with cellular activation and altered effector function.

PMID:26967895 [PubMed - as supplied by publisher]

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0150904

NEW BILL WOULD UP NIH/FDA FUNDING FOR NEGLECTED DISEASES

http://www.meaction.net/2016/03/10/new-bill-would-up-nihfda-funding-for-neglected-diseases/

With the FDA receiving a large chunk of these appropriations we could expect a beefing up of drug research for ME.

“(iv) research on new approaches to treatment of diseases using drugs, devices, or therapies that, at the time of distribution under paragraph (2), are not used or are underused.”
–S. 2624

Ampligen is a perfect example of a treatment that, either because of neglect or lack of awareness, has not been approved by the FDA even though it has been proven effective for many ME sufferers around the country. There is still no reliably effective treatment for ME, even Ampligen falls short on most accounts, but these new funds would be directed at finding such treatments and approving them for use quickly by eliminating a lot of red tape.

Hemispherx BioPharma, Inc (NYSEMKT:HEB) Reviews Ampligen Data with NINDS

http://www.journaltranscript.com/2016/03/hemispherx-biopharma-inc-nysemktheb-reviews-ampligen-data-with-ninds/

Hemispherx BioPharma, Inc (NYSEMKT:HEB) has announced that it has compared its results from the Ampligen data, with the National Institute of Neurological Disorders and Stroke. The research being conducted by the National Institute of Health focuses on Chronic Fatigue Syndrome. Hemispherx believes that the research would be a game changer for patients of the disease. The NIH had updated, the patients, on its research developments, under Francis S. Collins, on March 8 in an open call.

Thomas K. Equels, the CEO of HEB, stated that the company management had met with the delegates of the NIH, to review Apmligen studies, in order to answer questions, vital to gain FDA approval of the drug. The director of NINDS, Walter Koroshetz, had identified the syndrome as a “difficult problem” and had announced plans to include universities and companies to find a solution. It is expected that an estimated 20 NIH institutes would be working on the problem, to identify biomarkers, symptoms, mechanisms and causes of the disease.

Full transcript of the NIH tele-briefing is here.

http://www.meaction.net/2016/03/09/nih-telebriefing-update/

Robert Millers ampligen question is first on the Q&A

LOL, I'm not talking about repeating the philly business reports take (the article came out the same day as your blog) - HEB is undergoing the biggest change in decades and you haven't mentioned the most important aspect of their current business plan. Which is also the best reason for investing.

What wasn't that in your blog?

And what about the additional changes coming with new management? - referenced in several PR's and the Philly Business journal article?

So tell us why you are buying the stock?

The stock is not exactly 'hanging out' - it has more than doubled this year. What is your insight on why that may be?

Exclusive: More changes on deck for Philadelphia biotech firm
(subscription needed)
Philadelphia Business Journal
Mar 8, 2016, 1:53pm EST

'A piece of the pie is better than no pie at all.'

I like the new attitude.

NIH TELEBRIEFING WITH DIRECTOR FRANCIS COLLINS AND INTRAMURAL STUDY TEAM

http://www.meaction.net/2016/03/08/nih-telebriefing-update/

Below is a summary of the Q & A section of the call:

Robert Miller: What homework has been done thus far re Ampligen? Any talk with FDA? Only treatment ever to be in Phase 3 trials for ME/CFS. That opening for this drug potentially could lead to it being our AZT. Opening the door to pharma for much more research, plus give relief to many suffering patients.

Koroshetz: Goal is to try to get a treatment. To start, we are going to challenge our investigators to survey therapeutics that have been tried. Those are more short-term wins should they prove effective. New therapies are longer-term. We have an open door policy for people to come and propose… We have met with many investigators and Hemispherix company people.

They have presented data from previous studies. Serious consideration. There’s a process at NIH for funds to go out, so it’s peer review. We’re working with taxpayer dollars, so the process is very important to uphold. Will be having discussions on clinical trials as they come forward.

Hemispherx BioPharma Inc (NYSEMKT:HEB) Making A Comeback

http://www.insiderfinancial.com/hemispherx-biopharma-inc-nysemktheb-making-a-comeback/114732/

Overall, we do see potential with HEB and believe that with Dr. Carter gone, a turnaround is not only possible, but highly likely. We will be updating Insider Financial as soon as we know more.

This may or may not depend on finding a senior partner - but it looks like the NIH is willing to fund a clinical trial.

http://www.meaction.net/2015/12/21/nih-considering-ampligen-and-rituximab-trials/

Here is the NIH/CDC plan presented last week - in phase 3 of the plan, they already know they will be using an " immunomodulatory agent". That says ampligen to me, not rituximab.

http://www.cdc.gov/cdcgrandrounds/pdf/archives/2016/feb2016.pdf

Phase III
To conduct an early phase intervention study with an immunomodulatory agent that targets biomarkers validated in Phase II

Page 48 of the presentation

They are on AMEX, not NASDAQ. The $1 requirement does not apply.

My mistake - Equels is President. No new CEO has been named - my guess now, is that the company _is_ ripe for a partner and a new CEO will come with the partner. Go HEB!

Thomas Equels is the CEO, since early last fall. This change has been happening for awhile. William Mitchell is now the chairman of the board. Mitchell's signature on the June 5 experts letter - representing HEB. When I went to the manufacturing plant open house last fall - Carter was the only top staff person not there. Tightening up the business end might have been a pre-requisite of NIH funding - who knows, that's just a guess.

I'll just say I have a ship load of shares.

It looks like Carter is gone - the board has taken over the direction of the company. A positive thing I think.... he was on the way out in any case.

https://biz.yahoo.com/e/160218/heb8-k.html

No, there are only about 25 currently on ampligen via the amp511

Lutfiyah, more dot connecting... which I obviously like to do.

The CDC began a multi-site clinical assessment of CFS in 2012. There are 7 clinical sites. These are most of the leading U.S. experts in CFS. Patients enrolling in the new NIH Post-Infectious ME/CFS study will come from these clinical centers.

http://www.cdc.gov/cfs/programs/clinical-assessment/

There are 7 centers, with these expert clinicians: Peterson, Klimas, Lapp, Bateman, Podell, Kogelnik, Natelson

6 out of 7 signed the Open Letter to the FDA requesting ampligen be approved.

You think they'd make it easy for us? :)

No timeline. When NIH announced this new initiative in late October - they said they would increase funding, do this study and Koroshetz, director of NINDS, said they would move fairly quickly - which it appears they are doing, in terms of huge bureaucracies that is. I imagine NIH will periodically post updates for program status. Nothing precludes them from naming the 'immunological agent' at any point along the process however. So your guess is as good as mine... but HEB employees and board members are accumulating shares - so if you don't have many shares, I'd do the same. Helluva price and the trend is up.

Along with alferon manufacturing - I think that is the reason for the employee stock buying program and why ampligen approval is mentioned as part of the deal. As the only FDA drug to make it through pivotal phase ii and phase iii studies - it's tough to come up with anything else but ampligen - especially when Collins has mentioned it. When they get to the phase 3 part of the plan - the NIH will just announce - they won't present. Make sure you have plenty of shares when they do.

No problem. Here is the overview of todays presentation (the 1 hour video will be online in a couple of days):

Post-Infectious-Myalgic Encephalopathy/Chronic Fatigue Syndrome

Overall Hypothesis: PI-ME/CFS is triggered by a viral illness that results in immune mediated brain dysfunction

Phase I: To conduct a cross sectional study for deep phenotyping of PI-ME/CFS to define its pathophysiology

Phase II: To validate select biomarkers from phase I in a longitudinal study and establish objective end points for an intervention study

Phase III To conduct an early phase intervention study with an immunomodulatory agent that targets biomarkers validated in Phase II
====

NIH already knows they are going to use an immunomodulatory agent. I wonderrrrrrrr what it could be???

Yeah, the whole 30 year history of the disease has been surreal. The doctors who gave testimony, very powerful - the FDA thought they were outliers, that they were the most seriously ill. Gov't agencies are just now catching up. It is unbelievable.

After the 2012 Adcom meeting the FDA admitted they did not realize what a serious debilitating disease it is <sigh> - so the independent IOM and the NIH P2P reports helped them realize.

HEB has a big advantage - ampligen is the only drug to undergo pivotal phase II and phase III FDA trials. Not to mention 18+ years of cost recovery compassionate care treatment.

This is an NIH intramural study of 40 CFS patients and controls. A 'fishing expedition'.

It is related in a sense that both Lapp and Simmaron (Dan Peterson) are advisors. Both Lapp and Peterson are proponents of ampligen for CFS as reflected in the June 5 letter by 17 biomedical and clinical experts. Francis Collins stated in December that they are considering clinical trials of both ampligen and retuximab --- so it's worth keeping an eye out. IMO, an ampligen clinical trial is up next.

First Inpatient study of CFS conducted by NIH in 20+ years - we'll learn more tomorrow.

http://simmaronresearch.com/2016/02/hear-more-on-tuesday-about-nih-study-during-cdcs-grand-rounds/

You'll probably need to consider this December update as the update to that open letter.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=119341791

The NIH clinical study referred to in the post will be announced tomorrow at CDC Public Health Grand Rounds.

http://www.cdc.gov/cdcgrandrounds/archives/2016/february2016.htm

I expect an ampligen trial will be next on the list. They needed to get their own intramural study underway as a first move. I don't think there will ever be an update to the meeting requested in the letter - they'll just go ahead and do a clinical trial.

BTW, Charles Lapp is on the June 5 letter.

Drk, it's really not necessary to quote lines of my posts. We're the only ones having a conversation and double subject lines aren't very useful.

"waiting to see how they follow through this time" in the case of Zika doesn't make much sense either. Zika is a pandemic threat that comes under the heading of bio-defense. It's up to the government to follow through, to decide whether they want to use hemispherx technology or not because they will be paying for it. And since they are in active dialog with gov't reps - they are at least interested, in exploring or comparing HEB's technologies with other technologies.

Since you like ampligen - HEB has a phase II clinical ongoing at U. of Alabama for pandemic flu which they are considering. In fact, this clinical was recently updated on clinicaltrials.gov. The PR refers to it:

"A clinical protocol similar to an ongoing seasonal influenza vaccine protection clinical program at the University of Alabama (Vaccine, 32:5490–5495, 2104), is envisioned in which at risk populations would receive Ampligen® delivered intranasally."

The initial tech on this was done by the Japanese. Hasegawa. Pure genius. Here is Akira's slide presentation to WHO a few years ago and why the gov't might be interested in this technology.

http://www.who.int/immunization/research/meetings_workshops/Ainai_Akira.pdf

Not sure what you are talking about really - they have a plan for each of their programs. If, as you say, you have the Arrowhead report - you should know that.

Agree here Drk -- except for your business take on "getting out of their own way'. They've got the drugs - it is largely up to governments as gov'ts would need to find a way to disseminate the drugs.

This could be huge - maybe the biggest pandemic threat yet.

CDC confirms link between Zika, microcephaly in Brazilian babies who died

http://www.usatoday.com/story/news/2016/02/10/cdc-confirms-link-between-zika-microcephaly-brazilian-babies-who-died/80179898/

There was nothing arbitrary about pointing out that the term 'weasel words' is commonly used by bashers and hedgies trying to down this stock. It is rather incriminating and obvious.

And what about self interested iHub moderators using the boards to promote their own blogs? What section does that fall under?

LOL, you're no shareholder. If you search the term 'weasel words' on the yahoo heb board. Who do you get? 8^)

cya drkazmd

Drk, I'm afraid you don't know much.

Maybe they should just put you in charge of the company. All problems solved!

You wanted a research introduction to LDO, and here the company gave you exactly that. Amazing.

IMO, because of LDO's low cost, and easy administration - it has much larger long term potential. Research tamiflu stockpiling.

No company is perfect. The politics of CFS are fierce. Ampligen for CFS is HEB's most advanced program... going back a decade or more. Until recently, like the last year or two - federal agencies doubted the disease was real. For the FDA to approve a drug like ampligen, an immune modulator, they would have had to admit the disease was real. This battle is still going on in some quarters - research the PACE trial and James Coyne, a prestigious academic, saying this 2011 PACE trial, recommending CBT therapy and GET exercise, for CFS is a complete fraud. The politics are just now coming around.