In the midst of a devastating global crisis 2 years ago, a Ugandan physician was infected with Ebola in Sierra Leone as he was treating patients. He was hospitalized at the Frankfurt University Hospital and 12 days later he was unconscious, suffering from multiple organ failure.
By the time Aethlon Medical (NSDQ:AEMD) got permission to use its Hemopurifier device, the doctor required mechanical ventilation, continuous dialysis and vasopressor medications. After almost 7 hours of treatment with the single cartridge blood filtration device, the patient’s viral load dropped from 400,000 virus copies per milliliter of blood to 1,000 copies per milliliter. The doctor eventually made a full recovery.
Aethlon CEO Jim Joyce told MassDevice.com that this story is a powerful example of what the device can do for viruses that do not have a known vaccine. He also pointed out that the “one bug, one drug” approach that scientists have used for years is not always the most efficient way to combat infectious disease outbreaks.
“There’s just not enough candidates, realistically, to address these threats and many of the threats you don’t know what’s going to evolve next. As an example, Zika has been known since 1947, but no one could have predicted that it was going to unfold and become a threat at the pace that it did,” he said. “In reality, if you go to FDA’s own website, it would indicate that maybe 5 of every 5,000 drug candidates that initiate studies are approved for clinical studies and of those, 1 would be expected to be approved.”
The search for a broad-spectrum countermeasure to combat viruses is becoming increasingly urgent, as threats like Ebola and Zika have rocked the global health infrastructure in the last several years.
“From a congressional standpoint on Capitol Hill, we started talking about the need for a broad-spectrum countermeasure to address these threats more than a decade ago,” Joyce said.
The San Diego-based company’s Hemopurifier device is a single-use, disposable cartridge designed to target and filter out viruses or tumor-secreted exosomes. Blood flows through the cartridge into nearly 3,000 hollow fibers with pores 250 nanometers in diameter. A pressure deferential in the 1st third of the fiber pushes particles below 250 nanometers through the pores into a space between the fibers and the cartridge.
There an affinity agent binds to a disease-specific structure associated with viruses. The structure is something viruses co-opt from the host’s own cells during replication to avoid detection from the host’s immune system. But within the device, that signature is what binds viruses to the cartridge. Everything else continues to flow through the device.
“It’s a single-use, disposable cartridge and it’s blood in, blood out. We’re not pulling out plasma, then treating it, or anything of that nature,” Joyce told us. “The blood flows into the cartridge at about 200 milliliters a minute, so for your average-size individual the entire circulatory system might turn over through the cartridge about once every 15 minutes.”
The company is wrapping up a Phase I feasibility study, with plans to begin pivotal studies required for commercialization. With pathogens for which it’s impossible to run controlled clinical studies, Joyce said the company will pursue Humanitarian Use Device pathways. The Hemopurifier is approved for emergency use in treating Ebola in the U.S. and Canada.
“We think [the device] can be significantly important strategy in the case of viral pathogens where there isn’t a proven drug or vaccine to tip the balance in favor of the immune system,” Joyce said. “In cases where drugs and vaccines do exist, the work is an adjunct that can combine with other therapies without adding additional drug toxicity, yet it proves potential benefit of those therapies.”
Aethlon has conducted 4 studies overseas using the device with HIV and hepatitis C patients, as well as studies to capture H1-N1 swine flu virus, the H5-N1 bird flu virus, and even the reconstructive Spanish Flu of 1918. The company has also confirmed capture of chikungunya, West Nile virus and recently had its 1st data point demonstrating capture of Zika virus. Aethlon has also demonstrated in in vitro studies that its Hemopurifier device can capture tumor-derived exosomes.
“We’ve been very active in validating behind the scenes that indeed, our cartridge is broad-spectrum – and broad-spectrum in the sense that it’s not broad-spectrum against different strains of the same virus, but it’s actually broad-spectrum across different strains, species and families of viral pathogens,” Joyce explained.
As the company wrapped up its fiscal 2nd quarter ending Sept. 30, it faced a net loss of -$2.3 million, or -29¢ per share, compared to a net loss of -$1.2 million, or -16¢ per share in the same period last year.
“As we’re a clinical-stage company, some of the highlights aren’t truly impressive from a financial standpoint, but I think the key takeaway is that we’re closing in on completing our FDA-approved feasibility study for our Hemopurifier, which we believe is the 1st study of its kind to be approved by FDA for clinical studies.”
The company also hit all 29 milestones in its U.S. Defense Dept. contract with the Defense Advanced Research Projects Agency, which has generated about $5.9 million in revenue to date.
Joyce added that he’s proud that Aethlon has maintained a low burn rate over the years, keeping it to roughly $300,000 a month.
“Maintaining a low burn rate is historically really important for survival, and we’ve recognized that it gives us tremendous flexibility when we don’t have to stare down a need to keep running back to the financial market to raise tens of millions of dollars to support the advancement of a therapeutic,” he said. “We don’t expect the burn to change at any point in time in the next quarter or so, but we do expect it’ll ramp up as we continue to advance into larger clinical studies of different disease indications.”
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.