SAN DIEGO--(BUSINESS WIRE)--Aethlon Medical, Inc. (OTCBB:AEMD - News) announced today it has entered into a non-exclusive agreement with Bioserv Corporation dba NextPharma Technologies, to establish manufacturing of the Aethlon Hemopurifier® under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization. The Hemopurifier® is a first-in-class medical device that assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins from the entire circulatory system. Safety of the Hemopurifier® has been demonstrated in multi-site human studies, with robust viral load reductions observed in enrolled Hepatitis-C (HCV) infected patients. NextPharma is a world-class outsourcing partner for the medical industry. It’s San Diego location (formerly known as Bioserv Corporation) is a GMP contract manufacturer whose facility meets the regulatory and quality assurance compliance requirements of the FDA and is ISO13485:2003 certified for medical device manufacturing. In addition to establishing GMP, market clearance of the Hemopurifier® will be required by the U.S. Food and Drug Administration (FDA) prior to mainstream commercialization in the United States. Additional details regarding GMP information and QS regulations can be accessed online at: www.fda.gov/CDRH/DEVADVICE/32.html#introduction
“While GMP may not be required for clinical studies, it will position us to export our Hemopurifier® for sale as demand becomes established in India and other practitioner driven markets,” stated Aethlon Chairman and CEO, Jim Joyce. “Additionally, the manufacturing of our Hemopurifier® under GMP improves our readiness to respond to emergency and humanitarian use requests, including the sudden emergence of bioterror and pandemic threats,” concluded Joyce.
About NextPharma Technologies & Bioserv Corporation
NextPharma Technologies, headquartered in the UK and founded in 2000, is a world-class outsourcing partner to the pharmaceutical and biotechnology industry. The organization offers a full range of services from early phase product development, through clinical trial packaging to high volume commercial manufacturing. NextPharma operates globally with seven product development centers, seven manufacturing plants and six temperature controlled storage and distribution sites across Europe and North America, supplying customers in North America, Europe and Japan. NextPharma has 1,200 employees dedicated to serving over 200 customers world-wide and a customer base, which includes many of the world’s leading pharmaceutical, specialty pharma and biotech companies. NextPharma’s San Diego Facility (formerly known as Bioserv Corporation) is a cGMP contract manufacturing organization (CMO) founded in 1988. The facility meets the rigorous regulatory and quality assurance compliance requirements of the FDA and is ISO13485:2003 certified for medical device manufacturing. The manufacturing facilities include certified Class 100,000 (Class 8 or Class D), Class 10,000 (Class 7 or Class C), and Class 100 (Class 5 or Class A) areas, packaging, and cold chain, distribution and logistics services. Additional information can be accessed online at: www.nextpharma.com/
About Aethlon Medical
Aethlon Medical creates diagnostic and therapeutic filtration devices to improve the health of individuals afflicted with infectious disease and cancer. Our lead product, the Aethlon Hemopurifier®, is a first-in-class artificial adjunct to the immune system proven to capture infectious viruses and immunosuppressive particles from the human circulatory system. The device targets to inhibit disease progression of Hepatitis-C Virus (HCV) and Human Immunodeficiency Virus (HIV), and serves as a broad-spectrum treatment countermeasure against bioterror and emerging pandemic threats. The Hemopurifier® also holds promise in cancer care, as research studies verify the Hemopurifier® effectively captures immunosuppressive exosomes that are secreted by tumors to kill-off immune cells. At present, over sixty-five (65) Hemopurifier® treatments (representing approximately 260 hours of treatment time) have been conducted in multi-site studies at the Apollo Hospital, Fortis Hospital, and Sigma New-Life Hospital in India. The studies enrolled end-stage renal disease (ESRD) patients infected with either HCV or HIV. In addition to establishing treatment safety, robust viral load reductions have been reported in HCV-infected patients who completed a three-treatment protocol during the course of one week.
Research studies have also demonstrated the Hemopurifier® is effective in capturing a broad-spectrum of viruses untreatable with drug therapy, including several of world’s deadliest bioterror and pandemic threats. These include: Dengue hemorrhagic fever (DHF), Ebola hemorrhagic fever (EHF), Lassa hemorrhagic fever (LHF), H5N1 avian influenza (Bird Flu), the reconstructed 1918 influenza virus (r1918), West Nile virus (WNV), and Vaccinia and Monkeypox (MPV), which both serve as models for human smallpox infection. The studies were conducted with the assistance of researchers representing: The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID); The Centers for Disease Control and Prevention (CDC); The National Institute of Virology (NIV); The Battelle Biomedical Research Center (BBRC); and The Southwest Foundation for Biomedical Research (SFBR).
Beyond therapeutic market opportunities, Aethlon is leveraging principles underlying the Hemopurifier® technology platform to establish a pipeline of clinical and research diagnostic products and services. Additional information regarding Aethlon Medical can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the Company’s ability to raise capital when needed, the Company’s ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company’s ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company’s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company’s Securities and Exchange Commission filings.
Contact:
Aethlon Medical, Inc. Prashant Mehta, Ph.D. Director of Business Development 858-459-7800 x303 pmehta@aethlonmedical.com or Jim Frakes Senior VP Finance 858-459-7800 x300 jfrakes@aethlonmedical.com or Jim Joyce Chairman, CEO 858-459-7800 x301 jj@aethlonmedical.com
