SAN DIEGO, Oct. 16, 2017 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company
focused on unmet needs in global health and biodefense, announced
today that it has established a collaboration with iBio, Inc. (NYSE
AMERICAN: IBIO) to support potential large-scale production of the
Aethlon Hemopurifier®. iBio is a leading developer of
plant-based biopharmaceuticals.
The Aethlon Hemopurifier® is a first-in-class therapeutic device
designed to address life-threatening viral infections. The United
States Food and Drug Administration (FDA) has designated the
Hemopurifier® to an Expedited Access Pathway (EAP) related to the
treatment of life-threatening viruses that are not addressed with
approved therapies.
The goal of the Aethlon-iBio collaboration is to advance
large-scale production of a recombinant form of Galanthus
nivalis agglutinin (GNA), a plant-derived lectin that is
immobilized within the Hemopurifier® to bind infectious enveloped
viruses. Aethlon further disclosed that it completed a feasibility
study with iBio researchers that has confirmed the ability to
produce highly active recombinant GNA through the use of iBio's
plant based technology.
Dr. Barry Holtz, President of
iBio CDMO said, "Aethlon's clinical success backed by our cGMP
compliant therapeutic protein production capacity and expanded
classified manufacturing space for device manufacture are an ideal
combination for delivery of a new therapeutic approach to pandemic
disease and biothreats."
iBio's CDMO facilities were initially designed and constructed
under sponsorship of the Defense Advanced Research Projects Agency
(DARPA) of the U.S. Department of Defense, and have the capacity to
initiate a rapid production response to an infectious disease
outbreak or a bioterror attack and to manufacture large quantities
of recombinant proteins under Current Good Manufacturing Practices
(cGMP') of the U.S. Food and Drug Administration.
Jim Joyce, Chairman and CEO of
Aethlon stated, "The production of recombinant GNA in iBio's
large-scale manufacturing facilities establishes a pathway for us
to access a consistent, high quality supply that can support our
long-term clinical and commercialization objectives."
About Aethlon Medical, Inc.
Aethlon Medical is focused on addressing unmet needs in global
health and biodefense. The Aethlon Hemopurifier® is a
first-in-class therapeutic device designed to address
life-threatening viral infections. The United States Food and
Drug Administration (FDA) has designated the Hemopurifier® to an
Expedited Access Pathway (EAP) related to the treatment of
life-threatening viruses that are not addressed with approved
therapies.
In collaboration with leading government and non-government
research institutes, Aethlon has validated the ability of the
Hemopurifier® to capture a broad-spectrum of pandemic influenza
viruses, mosquito-borne viruses and deadly hemorrhagic
viruses. Based on its use to treat Ebola virus, the
Hemopurifier® was named a "Top 25 Invention" and one of the "Eleven
Most Remarkable Advances in Healthcare," by TIME Magazine.
Aethlon is also investigating the potential therapeutic use of
the Hemopurifier® to reduce the presence of tumor-derived exosomes,
which contribute to immune-suppression and the spread of metastasis
in cancer patients. Additionally, Aethlon is the majority
owner of Exosome Sciences, Inc. (ESI), which is focused on the
discovery of exosomal biomarkers to diagnose and monitor cancer and
neurological disorders, including Alzheimer's disease (AD) and
Chronic Traumatic Encephalopathy (CTE). Additional
information can be found online at www.AethlonMedical.com and
www.ExosomeSciences.com. You can also connect with us on
Twitter, LinkedIn, Facebook and Google+.
About iBio, Inc.
iBio, a leader in developing plant-based biopharmaceuticals,
provides a range of product and process development, analytical,
and manufacturing services at the large-scale development and
manufacturing facility of its subsidiary iBio CDMO, LLC. in Bryan,
Texas. The facility houses laboratory and pilot-scale
operations, as well as large-scale automated hydroponic systems
capable of growing over four million plants as "in process
inventory" and delivering over 300 kilograms of therapeutic protein
pharmaceutical active ingredient per year. iBio applies its
technology for the benefit of its clients and the advancement of
its own product interests. The Company's pipeline is comprised of
proprietary candidates for the treatment of a range of fibrotic
diseases including idiopathic pulmonary fibrosis, systemic
sclerosis, and scleroderma. IBIO-CFB03, based on the Company's
proprietary gene expression technology, is the Company's lead
therapeutic candidate being advanced for IND development.
Further information is available at: www.ibioinc.com
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 that involve
risks and uncertainties. Statements containing words such as "may,"
"believe," "anticipate," "expect," "intend," "plan," "project,"
"will," "projections," "estimate," or similar expressions
constitute forward-looking statements. Such forward-looking
statements are subject to significant risks and uncertainties and
actual results may differ materially from the results anticipated
in the forward-looking statements. Factors that may contribute to
such differences include, without limitation, the Company's ability
to maintain its listing on the Nasdaq Capital Market, or any other
national securities exchange, that the Company or its subsidiary
will not be able to commercialize its products, that the FDA will
not approve the initiation or continuation of the Company's
clinical programs or provide market clearance of the Company's
products, the Company's ability to raise capital when needed, the
Company's ability to complete the development of its planned
products, the Company's ability to manufacture its products either
internally or through outside companies, the impact of government
regulations, patent protection on the Company's proprietary
technology, the ability of the Company to meet the milestones
contemplated in its contract with DARPA, product liability
exposure, uncertainty of market acceptance, competition,
technological change, and other risk factors. The foregoing list of
risks and uncertainties is illustrative, but is not exhaustive.
Additional factors that could cause results to differ materially
from those anticipated in forward-looking statements can be found
under the caption "Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended March 31,
2017, and in the Company's other filings with the Securities
and Exchange Commission. Except as may be required by law, the
Company does not intend, nor does it undertake any duty, to update
this information to reflect future events or circumstances.
Company Contact:
Jim
Frakes
Chief Financial Officer
Aethlon Medical, Inc.
858-459-7800 extension 3300
Jfrakes@aethlonmedical.com
Investor Relations:
John
Marco
CORE IR
516 222 2560
johnm@coreir.com
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SOURCE Aethlon Medical, Inc.