Hemispherx Enhances Manufacturing Efficiency of Ampligen
January 11 2018 - 8:30AM
Hemispherx Biopharma, Inc. (NYSE American:HEB),
has successfully tested a new chemical catalyst used in the
manufacturing process of Ampligen®, a novel molecule currently
being tested in combination therapy to potentially enhance the
performance of checkpoint inhibitors, one of the fastest growing
classes of immuno-oncology agents.
Carol Smith, PhD, chief manufacturing officer, said
“This development has a number of tangible benefits in terms
of improved manufacturing efficiency and assured availability of a
key manufacturing material. The new development can provide a
consistent enzyme product, uninterrupted production of Ampligen®,
and, in the long run, reduce production costs.”
The manufacture of Ampligen®, a double-stranded RNA, requires an
enzyme which historically has been difficult to
prepare. Recently, the gene coding for this enzyme was cloned
and the production of the expressed enzyme is currently being
scaled up for use in the manufacture of both RNA strands that are
combined to form the Ampligen® molecule.
Hemispherx said that, during the scale up of the cloned enzyme,
it has the equivalent of 18,000 vials of base product now ready for
compound, fill and finish for projected distribution this year with
an estimated value of $10.3 million. Development of the new
enzyme process is planned to facilitate production of the Ampligen®
RNA strands for future needs.
Earlier this week, Hemispherx announced that a presentation will
be made by Pawel Kalinski, MD, PhD, Rustum Family Professor for
Molecular Therapeutic and Translational Research at Roswell Park
Cancer Institute in Buffalo, NY on January 24 at the
Immuno-Oncology Frontiers Conference in Miami, FL. detailing
evidence of a favorable immuno-modulatory activity of Ampligen® on
the tumor microenvironment, which may help convert cold tumors that
are unresponsive to immunotherapy to tumors that will respond to
immunotherapeutic drugs such as checkpoint inhibitors.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical
company engaged in the clinical development of new drug entities
for treatment of seriously debilitating disorders. Hemispherx’s
flagship products include Alferon N Injection® and the experimental
therapeutic rintatolimod (tradenames Ampligen® or Rintamod®).
Rintatolimod is an experimental RNA nucleic acid being developed
for globally important debilitating diseases and disorders of the
immune system, including Myalgic Encephalomyelitis/Chronic Fatigue
Syndrome (ME/CFS). Hemispherx’s platform technology includes
components for potential treatment of various severely debilitating
and life threatening diseases. Because rintatolimod is experimental
in nature, it is not designated safe and effective by the FDA for
general use and is legally available only through clinical
trials.
Cautionary StatementSome of the statements
included in this press release may be forward-looking statements
that involve a number of risks and uncertainties, including
statements about the expectation that the new enzyme process
development will facilitate more reliable and efficient manufacture
of Ampligen® or the estimated value of the product now ready for
compound, fill and finish. 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 Phone Number:
800-778-4042 Email: IR@hemispherx.net
Hemispherx Biopharma (AMEX:HEB)
Historical Stock Chart
From Aug 2024 to Sep 2024
Hemispherx Biopharma (AMEX:HEB)
Historical Stock Chart
From Sep 2023 to Sep 2024