Hemispherx Updates Stockholders, Highlighting Ampligen’s Role in Enhancing Immunotherapeutic Therapies
August 13 2018 - 8:30AM
Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma
R&D and emerging commercial growth company focused on unmet
medical needs in immunology, is pleased to announce it mailed a
letter to stockholders on August 11, 2018 detailing recent
developments, including financial results and new business
opportunities.
Highlights include:
- A strategic decision to prioritize Ampligen’s potential in
combination therapeutic treatments in immuno-oncology. Synergistic
anti-tumor activity and/or increased median survival has been
observed when Ampligen was added to other anti-cancer agents in
three pre-clinical studies. As a result, we are now working
with several major cancer research centers to initiate Phase 1 and
Phase 2 clinical trials combining Ampligen with FDA-approved
checkpoint blockade therapies;
- Completion of the initial phase of the Ampligen
commercially-scaled production plan to support these trials plus
current and anticipated commercial orders from (1) Argentina, where
Ampligen was recently approved for the treatment of Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS); and (2)
existing U.S. and international ME/CFS early access programs, such
as AMP-511;
- Continuation of our program to secure U.S. FDA approval for
Ampligen for the treatment of ME/CFS. In the meantime, we have
expanded the Treatment Protocol/Expanded Access Programs for ME/CFS
in the U.S. to new enrollees;
- Price increase approved by the FDA for U.S. programs from $75
per vial to $200 per vial, with sales commencing this quarter and
volume of sales projected to increase over the next six
months;
- Amending of our agreement with myTomorrows to include
management of two Special Access Programs in Canada, one for
patients with pancreatic cancer, the other for patients suffering
from ME/CFS;
- Progress toward legal access to Ampligen in other countries
where early access programs exist for serious diseases with unmet
medical need;
- Initiation of plans to change our corporate name to Amplified
Immune Modulation Inc., d/b/a A.I.M. Immuno-pharma, with a
corresponding reservation of the ticker symbol AIM, to more
accurately reflect the Company’s prioritizing of
immuno-oncology.
To read the letter to stockholders in full, please
visit: http://ir.hemispherx.net/Annual_Stockholder_Meeting.
“We remain optimistic about Ampligen’s prospects as we move
closer to its commercialization, especially as we approach its
commercial launch pursuant to approval in Argentina,” said Thomas
K. Equels, the Chief Executive Officer of Hemispherx. “Our top
priority is validating Ampligen’s role in enhancing the performance
of current immunotherapeutic drugs.”
About Hemispherx Biopharma Hemispherx
Biopharma, Inc. is an immuno-pharma R&D and emerging commercial
growth company focused on unmet medical needs in immunology.
Hemispherx's flagship products include the Argentina-approved drug
rintatolimod (trade names Ampligen® or Rintamod®) and the
FDA-approved drug Alferon N Injection®. Based on results of
published, peer reviewed pre-clinical studies and clinical trials,
Hemispherx believe that Ampligen® may have broad-spectrum
anti-viral and anti-cancer properties. Clinical trials of Ampligen®
already conducted by Hemispherx include studies of the potential
treatment of cancer patients with renal cell carcinoma and
malignant melanoma, CFS, Hepatitis B and HIV. All of these
potential uses will require additional clinical trials to generate
the safety and effectiveness data necessary to support regulatory
approval. Rintatolimod is a double-stranded RNA being developed for
globally important debilitating diseases and disorders of the
immune system. Commercialization of Ampligen® in Argentina will
require, among other things, an appropriate reimbursement level,
appropriate marketing strategies, completion of manufacturing
preparations for launch (including possible requirements for
approval of final manufacturing) and we most likely will need
additional funds to manufacture product at a sufficient level for a
commercial launch.
Cautionary StatementSome of the statements
included in this press release may be forward-looking statements
that involve a number of risks and uncertainties. Among other
things, for those statements, we claim the protection of the safe
harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. Any forward-looking
statements set forth in this press release speak only as of the
date of this press release. We do not undertake to update any of
these forward-looking statements to reflect events or circumstances
that occur after the date hereof. This press release and prior
releases are available at www.hemispherx.net. The information found
on our website is not incorporated by reference into this press
release and is included for reference purposes only.
ContactHemispherx Biopharma, Inc. Phone Number:
800-778-4042 Email: IR@hemispherx.net
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