No Adverse Events in Animal Studies
Aethlon Medical, Inc. (OTCBB: AEMD) today reported new data related to the safe use of the Hemopurifier(TM) treatment technology in animal studies. Researchers documented that the Hemopurifier, which has been developed to treat individuals infected with HIV (the AIDS virus), Hepatitis-C (HCV), and bioweapon threats, including Smallpox, was able to treat for extended periods of time without any adverse events. Aethlon has previously published pre-clinical data related to the rapid clearance of HIV, HCV and Smallpox related viruses from human blood. Aethlon Chairman & CEO James A. Joyce stated, "The demonstration of safety in animals combined with our known ability to capture infectious agents from human blood provides further clarity to our vision of treating humans in a safe and effective manner."
The study involved a total of fifteen Hemopurifier treatment procedures that were performed on six different New Zealand white rabbits. Treatment times ranged from 45 minutes to five hours with an average treatment period of 2.9 hours in the study. Blood flow rates allowed for the entire blood system to circulate through the Hemopurifier every twenty minutes. In general, the animals tolerated the Hemopurifier treatment well and were able to move about freely within a restricted space. The most common interruption during the procedure was related to excessive animal movement that resulted in low arterial side pressures due to partial occlusion of the catheter. Such issues are not expected in human treatment. Blood studies of both a control dialysis cartridge and the Hemopurifier showed a general diminution of HCT, RBC and several other parameters except for Na+. In general, the control dialysis cartridge caused greater decreases in blood cells, metal ions and metabolites than did the Hemopurifier. Blood changes between the control dialysis cartridge and the Hemopurifier were a 32% vs. 20% decrease in thrombocytes and a 12% decrease vs. an 18% increase in leukocytes respectively. In every case, the observed blood chemistry changes were temporary and subsided prior to the next treatment. The attending veterinarian felt that exposure of the rabbits to antigens present in a companion animal dialysis clinic but not normally present in the rabbit hatchery (i.e. dogs, cats and other animals undergoing treatment) was the likely explanation for the increase in leukocyte levels. Regardless, no infections were ever observed. On two occasions, core body temperature rose from 102.2 to 105.2 degrees F during the Hemopurifier treatment. However, simply moving the rabbits from their cages to the treatment facility also produced similar temperature elevations up to 105 degrees F. Such data suggests that the temporary increase in temperature was not directly related to the Hemopurifier treatment. A decrease in thrombocytes is a common consequence associated with dialysis treatment. In conclusion, Aethlon researchers did not observe any adverse events during the Hemopurifier animal study. The choice to utilize rabbits in the study was related to the similarity in the infection pathogenesis of rabbit Pox with human Smallpox. As smallpox efficacy studies are not allowed in humans, related animal studies are the primary challenge for market approval as a treatment countermeasure. Aethlon Chief Scientific Officer Dr. Richard Tullis added, "I am very pleased with the results of this study. The rabbits, which are normally more fragile than other test species, have tolerated the Hemopurifier even better than we expected. Although the maximum treatment time was five hours, there is no reason to believe that the animals would not be able to tolerate much longer treatments. During the treatment they often sit up and investigate their surroundings."
About Aethlon Medical
Aethlon Medical is pioneering the development of viral filtration devices to treat drug and vaccine resistant pathogens. The market focus is the treatment of the Human Immunodeficiency Virus (HIV), Hepatitis-C (HCV), and Biological Weapon candidates. Aethlon has an experienced management team, which receives support and guidance from globally recognized science advisors representing the infectious disease, biowarfare and dialysis industries. Clinical Trials to treat HIV and HCV patients in India are scheduled to begin in the coming months, and U.S. clinical studies are expected to begin later this year.
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.
Source: Aethlon Medical, Inc.