Aethlon Medical Announces Large-Scale Production Collaboration
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.
Chief Financial Officer
Aethlon Medical, Inc.
858-459-7800 extension 3300
516 222 2560
SOURCE Aethlon Medical, Inc.
Released October 16, 2017