Aethlon Medical 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.
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.