Ampligen - Hemispherx Biopharma re ME/CFS

For health, I would be willing to sell a kidney! ( joking... not really ...but you get my drift). Cost I would sell everything I own or do whatever once I have energy. Is the access that kills me.

 

Second Large Shipment Dispatched to Second Major Clinic
OCALA, Fla., Jan. 02, 2019 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, shipped 325 recently manufactured vials of Ampligen to the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) clinical site at Incline Village, Nevada, run by Daniel Peterson, MD. This clinic is at the forefront of ME/CFS research and treatment. The vials will be used in the Expanded Access Program ("EAP") known as "AMP-511". The FDA authorized the AMP-511 protocol to treat ME/CFS patients in an effort to expand compassionate care in the fight against this quality-of-life impacting disease where there is no commercially approved therapy.

https://www.nasdaq.com/press-releas...ss-program-for-ampligen-in-the-20190102-00354

 

Does one vial equate to one treatment? And each patient needs 2-3 per week?

If i’ve made the right assumptions, 325 vials won’t treat many patients.

About half way down the link, there is a para referencing new and previously treated patients. Am so brainfogged ( Xmas outing v severe PEM) I cannot decipher it.

 

I've heard that Peterson is limiting his ampligen patients.

The paragraph refers to a future planned trial (to satisfy the FDA, the 2nd confirmatory phase 3) and those that have received ampligen in any previous trial will not be eligible for the planned trial and thus the only way for those patients to get ampigen is via the amp511 or other EAP program.

 

Do you know how many patients the second confirmatory phase 3 will encompass @sjJohnny? Thanks.

 

No details are known, I think they are still negotiating (and have been for a long while). My guess would be 300+

 

Ten years to be exact. Well, ten years come November...

 

Not to get technical Danny, but the Advisory Committee gave a mostly negative vote in December of 2012, with the FDA declining approval in February of 2013. However, I predict 2019 to be the year of HEB (or AIM as they will change their name). Both the CEO and the leading Cancer researcher are being more than a little bold at predicting break through status for ampligen in cancer. One benefit would be, enough money to conduct or partner the phase 3 CFS trial the FDA has requested.

 

They have approval for a small Ampligen trial on Breast Cancer, and are also hoping to do another on ovarian cancer.

 

They have 2 cancer trials underway, IRB approval to start the triple negative breast cancer and a planned start to ovarian trial at the end of this month - plus at least 4 more in the planning stages. These are trials of the toughest cancers and toughest patients - those who have failed treatment and their cancers have metastasized. Success in any of them will be a very big deal and their pre-clinical work points to success. Pawel Kalinski, lead researcher at Roswell Park, has been working with ampligen in cancer trials, since 2013.

 

"
Hemispherx Biopharma’s CEO to Present at the 15th Annual NobleConXV Conference
OCALA, Fla., Jan. 24, 2019 (GLOBE NEWSWIRE) -- (NYSE American: HEB) — Hemispherx Biopharma Inc., an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, announced today that CEO Thomas K. Equels will present at NobleConXV — Noble Capital Markets’ Fifteenth Annual Investor Conference at the W Hotel, Fort Lauderdale, Fla. — on Tuesday, January 29 at 11:30 a.m. Eastern Standard Time.

A high-definition, video webcast of the presentation will be available the following day on the company's website www.hemispherx.net, and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website (https://nobleconference.com) and on the new investor portal created by Noble called Channelchek (https://www.channelchek.com). The webcast will be archived on the company's website, the NobleCon website and on Channelchek.com for 90 days following the event.

Thomas K. Equels, M.S. J.D., chief executive officer of Hemispherx, will be presenting and meeting one-on-one with investors. Equels' presentation will focus on immuno-oncology and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). He will also discuss how the company is working with several major cancer research centers with ongoing Phase 1 and Phase 2 clinical trials combining Ampligen with FDA-approved checkpoint blockade therapies in several different and highly lethal solid tumors. Hemispherx current corporate presentation can be found here https://ir.hemispherx.net/Events_Presentations.
"

 

It’s interesting about the triple negative breast cancer as the gene I’m interested in FOXC1 links to this and cfs I think
Under not over expression though

 

Moderator note: This post has been copied to start a new thread in the Fundraising subforum here.

 

Hemispherx Links Stanford's ME/CFS Diagnostic to a Potential Path Forward for Ampligen Commercialization

...
"This is a potentially landmark study on two fronts," said Thomas K. Equels, CEO of Hemispherx. "First, ME/CFS has been thought of by many as a psychological disorder without a physical basis, leaving ME/CFS sufferers with the pain of the disease and a sense of hopelessness. This diagnostic creates a new paradigm of hope for therapy for those with the disease. Second, a validated blood-based method to diagnose ME/CFS would have a profound impact on how it is studied and treated by clearly identifying whether a subject has the disease. We look forward to the day when we can incorporate such a diagnostic platform into our own clinical testing for ME/CFS. We have the only late-stage drug candidate in the FDA pipeline and have been asked to do a confirmatory clinical trial. If properly validated with larger numbers of subjects, a blood-based diagnostic for ME/CFS should help in achieving regulatory approval."

https://hemispherx.irpass.com/Hemis...ial-Path-Forward-for-Ampligen-Commercializati

 

https://www.proactiveinvestors.com/...erapy-trials-of-its-drug-ampligen-222245.html
Hemispherx Biopharma issues updates for ongoing immunotherapy trials of its drug Ampligen



New uses for ampligen

 

https://finance.yahoo.com/news/hemi...JO4V2GRSU63y0xOKjJB_kIIC16c8Og-4zKCoarxlGyk6R

 

Hemispherx Biopharma, Inc. Changes Name to AIM ImmunoTech Inc. Reflecting Ampligen’s® Immuno Modulation Progress in Ongoing Oncology Clinical Trials and ME/CFS
Aug 23

https://www.nasdaq.com/press-releas...ng-ampligens-immuno-modulation-20190823-00164

 

Their choice of acronym is good marketing. Perhaps this re-branding will help them move forward.

 

AIM ImmunoTech to Present at the 21st Annual Rodman & Renshaw Global Investment Conference in New York City on September 10th

Read more: http://www.digitaljournal.com/pr/4436902#ixzz5ykQqbKo5

https://finance.yahoo.com/news/aim-...HOczG7N0iZ40OYi3zGYtdR7aC0T9mgyE_hDMm2FFAH5v4

 

AIM ImmunoTech's Ampligen Receives Clearance from FDA for Exportation to Argentina for the Treatment of Severe Chronic Fatigue Syndrome
http://aimimmuno.irpass.com/ViewEmail.asp?b=2265&id=183751&p=2169290&I=1201116-E6Z6D3a5b9

AIM ImmunoTech Inc. Announces the U.S. Department of Defense's Award of $6.42M to Roswell Park Comprehensive Cancer Center to Study Ampligen as Part of a New Treatment of Brain-Metastatic Breast Cancer
https://aimimmuno.irpass.com/AIM-Im...ses-Award-of-642M-to-Roswell-Park-Comprehensi

AIM ImmunoTech Inc. Announces a Second DoD Award, This One of $8.3 Million, to Fund Phase 2 Clinical Trial to Study Ampligen as Part of a New Treatment for Brain-Metastatic Breast Cancer at the Moffitt Cancer Center
https://aimimmuno.irpass.com/AIM-Im...e-of-83-Million-to-Fund-Phase-2-Clinical-Tria