Ampligen for ME/CFS

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Hemispherx Biopharma Inc. Announces First Large Ampligen Shipment to a Clinical Site for Use in U.S. Expanded Access Program

http://ir.hemispherx.net/profiles/i...9410&GoTopage=1&Category=2178&BzID=2265&G=980

Hemispherx recently announced the expansion of the protocol, allowing new enrollees, who would not be eligible to participate in a future confirmatory trial. Hemispherx continues to believe that this study does not and will not interfere with any future studies planned to obtain marketing approval. Any future confirmatory clinical trial is not expected to include previously-treated patients such as those currently enrolled in the AMP-511 protocol, and we do not believe that recruitment of new patients into any future studies will be impaired by additional enrollment in the treatment protocol. Expansion was possible because this year Hemispherx successfully produced two commercial-sized lots of Ampligen, which were filled and finished into approximately 16,000 vials. Both lots have passed all necessary release testing and are now available for distribution.
 
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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.
 
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.
 
sjJohnny said:
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.
Click to expand...
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.
 
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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
 
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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
 
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