Aethlon Medical Discloses Hemopurifier® Clinical Trial and Manufacturing Advancements
SAN DIEGO, March 31, 2016 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), reported that the recently appointed principal investigator of its FDA approved clinical study in Houston, Texas, has completed a six-treatment protocol of Hemopurifier therapy in an enrolled patient and has consented the enrollment of the next patient. The information was disclosed during an Annual Meeting of Stockholders conducted on March 29, 2016 in San Diego, California. Aethlon had previously disclosed in February 2016, that it had completed the formal training of its new principal investigator, Dr. Ronald Ralph, and had additionally trained two sub-principal investigators to support the advancement of its clinical study.
Aethlon also disclosed that during the principal investigator transition, it leveraged a Department of Defense contract with the Defense Advanced Research Projects Agency (DARPA) to fund the establishment of current good manufacturing practice (cGMP) systems to support Hemopurifier production and quality control. The Company has now completed its first Hemopurifier production lot under cGMP, which is being utilized to support its current clinical study.
"While our principal investigator transition delayed the advancement of our clinical study, we utilized the interim period to establish cGMP systems and now have our study back on track," stated Jim Joyce, Chairman & CEO of Aethlon Medical. "We can now refocus on the clinical progression of Hemopurifier therapy as a leading broad-spectrum countermeasure against infectious viral pathogens."
Aethlon's FDA approved feasibility study is being conducted at DaVita Med Center Dialysis in Houston. The 10-patient study supports the advancement of Hemopurifier therapy as a broad-spectrum countermeasure against bioterror and pandemic threat viruses. Upon successful completion, the study also provides a potential pathway into pivotal studies of chronic or latent viral pathogens where it is feasible to conduct controlled efficacy studies.
About Aethlon Medical, Inc.
Aethlon Medical creates affinity biofiltration devices to treat life-threatening diseases. The Aethlon Hemopurifier® is a leading broad-spectrum treatment countermeasure against infectious viral pathogens. The device, which has been successfully administered to individuals infected with HIV, Hepatitis C (HCV) and Ebola virus, is currently the subject of FDA approved clinical studies. Aethlon is also studying the potential use of the Hemopurifier® to address exosomes secreted by tumors to promote the spread of metastasis and suppress the immune system of cancer patients. The Company provides government contracting services to the Defense Advanced Research Projects Agency (DARPA) related to the development of a biofiltration device to treat sepsis and maintains majority ownership of Exosome Sciences, Inc., which is focused on the discovery of exosomal biomarkers to diagnose and monitor Chronic Traumatic Encephalopathy (CTE) and other neurological disorders. Additional information can be found online at www.AethlonMedical.com or you can connect with us on Twitter, LinkedIn, Facebook and Google+.
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, including products developed by Exosome Sciences, Inc., 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, 2015, 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.
Mike Smargiassi/Brad Edwards
Brainerd Communicators, Inc
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SOURCE Aethlon Medical, Inc.
Released March 31, 2016