Aethlon Medical (OTCQB:AEMD), sporting FDA approval of an investigational drug exemption (IDE), plans to begin treating patients infected with hepatitis C virus (HCV) early next year in a feasibility study to demonstrate the safety of its Hemopurifier.
The Hemopurifier is a therapeutic filtration cartridge designed for use on existing dialysis and CRRT machines. The device targets the rapid elimination of circulating infectious disease and cancer targets without removing essential blood components required for health.
“Obtaining FDA permission to initiate human studies has been our most important objective for several years,” chairman and CEO Jim Joyce says in an interview with BioTuesdays.com.
“Previously, in the treatment of HCV-infected individuals, we have demonstrated that our Hemopurifier could eliminate the presence of HCV in as little a seven days when utilized in combination with interferon-based therapy,” Mr. Joyce says.
“We have also demonstrated that short-term administration of Hemopurifier therapy was able to reduce viral load by greater than 90% in an HIV-AIDS dialysis patient who was not receiving any form of antiviral drug therapy.”
The company has collected data from approximately 100 treatment experiences in HCV-infected individuals in India, where the device is available on a compassionate basis to treat the disease.
“Now that the FDA has approved our IDE, we would also like to leverage the recent discovery that our Hemopurifier is able to capture tumor-secreted exosomes, which suppress the immune response of cancer patients,” Mr. Joyce contends.
“Research publications also report that exosomes facilitate tumor growth, promote the spread of metastasis and contribute to drug resistance,” he adds. “By reducing the presence of these particles, we hope to save lives by tipping therapeutic balance in favor of those with cancer.”
In its cancer program, Aethlon plans to utilize its Hemopurifier to target the elimination of circulating tumor-secreting exosomes as an adjunct therapy to improve cancer treatment. Mr. Joyce points to a landmark publication in the June 2012 issue of Nature that concluded exosomes seed the creation and spread of metastasis through a mechanism that wasn’t previously known. Additionally, he states that the quantity of exosomes in circulation can correlate with a patient’s stage of cancer.
“Tumor-secreted exosomes will not be present in a person who is not afflicted with cancer. However, a late-stage cancer patient can have massive levels of circulating exosomes.”
Under the IDE-approved protocol, Aethlon will enroll 10 end-stage renal disease patients in the feasibility study who are infected with HCV. The completion of the study is anticipated in mid-2014, and a successful outcome will set the stage for pivotal studies required for U.S. market clearance.
“With our IDE approved, we have the potential to leverage data from the feasibility study as a modular strategy to expand into other disease conditions,” he adds. “At present, we are discussing several cancer-related targets with clinical collaborators and expect to submit an IDE for one of them prior to the end of 2014.”
Mr. Joyce explains that Aethlon’s goal with the Hemopurifier is to optimize drug therapy rather than be a standalone product. “We don’t position ourselves as a competitor to drug therapy, but rather, we think there is tremendous value in improving patient response to established standard of care therapies and do so without adding drug toxicity.”
In HCV, for example, “we believe the administration of our device in the first few days of drug therapy synergistically improves the early viral kinetic response to therapy.” In addition, the Hemopurifier has the potential to address viral rebound in patients who often are forced to discontinue therapy as a result of HCV establishing resistance to drug regimens, he suggests.
Aethlon has also demonstrated that the Hemopurifier can capture a broad spectrum of viral pathogens considered to be bioterror or pandemic threats. In terms of pandemic influenza, Aethlon previously disclosed that in collaboration with Battelle Memorial Research Institute, the Hemopurifier was able to capture the H1N1 and H5N1 viral strains, as well as the reconstruction of the Spanish flu of 1918.
In collaboration with the U.S. Army Medical Research Institute for Infectious Disease, researchers have demonstrated the cartridge’s ability to capture Ebola virus, including the Zaire strain of the disease. The company also validated the capture of Dengue hemorrhagic virus through a collaboration with the National Institute of Virology in India.
Mr. Joyce recalls that when Aethlon was seeking an IDE, a reviewer at the FDA asked how the company knew the Hemopurifier was capturing viruses.
“So we established a protocol to elute the biological fluid from the Hemopurifier after treatment so that we could quantify what was captured in the cartridge and no longer circulating in the patient. The result was that the Hemopurifier was demonstrated to capture as many as 300 billion copies of virus during a six-hour treatment,” he says. By way of comparison, if you lined up 300 billion ants end-to-end, they would stretch around the globe 12 times.
Last month, Aethlon launched its Exosome Sciences unit to pursue exosome-based strategies to diagnose and monitor the progression of cancer, infectious disease and other life-threatening conditions. Exosome Sciences’ lead product is an assay called, ELLSA, which has been validated to identify the presence of exosomes underlying HIV, TB, and various forms of cancer, including ovarian, melanoma, breast, colorectal, lymphoma and melanoma.
“Our goal is to create a series of diagnostic tools to do liquid biopsies in cancer,” Mr. Joyce says. “Additionally, the ELLSA assay has the potential to become a companion diagnostic that determines when to initiate Hemopurifier therapy and monitors patient response,” he adds.
The company has attracted Dr. Douglas Taylor, who first discovered tumor-secreting exosomes, as chief scientific officer of Exosome Sciences, and his wife, Dr. Cicek Gercel-Taylor, another pioneer in the field of exosome biology, as clinical research director of the new company.
Aethlon is also leveraging its ADAPT platform for the treatment of sepsis to save lives of the American military on the battlefield. In 2011, the company signed a five-year, $6.8-million contract with the Defense Advanced Research Projects Agency (DARPA), under its Dialysis-Like Therapeutics (DLT) program, to develop a portable medical device that would reduce the incidence of sepsis in combat-injured soldiers and civilians.
Under the contract, Aethlon is developing a therapeutic cartridge for the selective clearance of several septic activators from the circulatory system and a blood processing instrument to deliver various extracorporeal therapies without the need to administer systemic anticoagulants.
Earlier this year, a group consisting of Battelle, Aethlon and NxStage Medical, won a four-year, $22.8-million contract from DARPA to integrate component technologies developed in the DLT program into a medical device that would save military and civilian lives by effectively treating sepsis.
“These contracts have certainly helped to increase the awareness and credibility of our science within the medical community,” Mr. Joyce notes.