Aethlon Medical's (San Diego) blood filtration device, the Hemopurifier, has successfully removed 96% of H1NI in blood plasma samples as reported from an emergency study authorized by the U.S. Department of Health and Human Services (HHS).

"At this point we're in discussions as to what the potential next steps might be in terms of clinical programs with HHS. We're watching how H1N1 evolves and there are certainly different opportunities in terms of getting approval via emergency use authorization or humanitarian use. Should H1N1 become virulent, then we think it should be something seriously considered," Aethlon's chairman/CEO, Jim Joyce, told Medical Device Daily.

Joyce said the tipping point for an early emergency use authorization of any type will be if the virus mutates.

"There are no reports of mutation yet, but you're seeing that the hard-hit population has been people under 25, which is concerning because there's a certain portion of that population that should have a robust immune response. Researchers are now trying to understand how it goes from infection to death in a very short time in children. Given these events, there are some initial indications [that H1N1 could be mutating], but nothing solid yet."

Joyce explained that the Hemopurifier isn't just a filtration device; he calls it as an adjunct and treatment enhancement device because it can be used in conjunction with common antiviral medication to rid the body of the virus.

"The concept of enhancing the ability of a drug to be effective is no longer theoretical," Joyce said. "It's proven. There's a very strong precedent now. Not only can the Hemopurifier enhance outcomes, it can do so dramatically."

He refers to studies and subsequent data related to the Hemopurifier's use to fight hepatitis-C (HCV), the company's original indication. Potential applications and related studies focus on a variety of pathogens that infect the blood including HIV, hemorrhagic fever and cytomegalovirus.

But heightened concerns over the H1N1 pandemic led to the U.S. government's move to start testing the filter against this new influenza. Joyce said Aethlon was asked to ship an undisclosed number of the devices to "a research institute" for testing by third-party researchers.

Why all the secrecy?

"As this disease has grown, there's sensitivity to organizations that are housing the virus, especially if they're in geographically centralized areas," Joyce said, adding that further details of the study are confidential until the HHS signs off.

Researchers involved are expected to publish their results in a peer-reviewed journal in the near future.

What Joyce was able to disclose are some top line data results that show the longer the device is used, the more effective it is at removing a virus from blood. Hemopurifier removed 68% of H1N1 virus from blood plasma in 30 minutes, 80% of the virus in two hours, and there was a 96% reduction of H1N1 observed at six hours.

Joyce said it's this feature that will set the Hemopurifier apart from its closest competitors, whether used against H1NI or HIV.

"There's a very important mechanism of how our cartridge works," he said. "It's selective for removing the virus and doesn't indiscriminately remove particles in the blood that are needed. The other factor that's advantageous is that it removes proteins that shed from virus, so we can preserve immune cells. We see the benefit in use with antivirals because we think it enhances the ability for antivirals to work, but we also see it as immunotherapeutic."

Asahi Kasei Medical (Tokyo) has developed a similar blood filtration device called Planova filters, and the company has even launched a direct-to-consumer website touting its benefits in chronic hepatitis treatment as approved in Japan. But Joyce points out that this device's potential applications are limited because it strips the blood of too many components, limiting the amount of time a patient could endure the blood cleansing.

"But what Asahi has done is to validate the concept of a treatment enhancement device and we're looking to follow along and improve on that," he said.

Hemopurifier employs hollow-fiber dialysis along with affinity chromatography to selectively bind envelope viruses. The filtration cartridge is able to capture circulating viruses, viral proteins and toxins in an effort to reduce viral load so that the patient's natural immunity can recover to effectively kill off the infection. But Hemopurifier can also be used in conjunction with drugs and vaccines.

Earlier this year, Aethlon reported results of the first human study of Hemopurifier to treat HIV. Viral load was reduced by 92% in an HIV-infected individual who received a total of 12 Hemopurifier treatments administered three times a week over the span of one month (MDD, March 17, 2009)

But the majority of research has been focused on HCV with results from various studies that demonstrate robust viral load reductions (MDD, Jan. 27, 2009).

In addition to tackling numerous viral indications, Joyce pointed out that Hemopurifier could aid drug research because the filter isolates live viruses from the blood.

"Normally researchers are challenged because they don't have the quantities of virus they need," he said. "Usually when it grows in culture, it evolves differently than in the body. We could provide quantities of virus from patients so that drug companies could examine the various strains which would provide better insight into how the virus is evolving."

To get the big picture on how the med tech sector is reacting in response to the pandemic, check out MDD's Medical Technology and Pandemic Threats: Swine, Avian and SARS 2009 at www.medicaldevicedaily.com.

Lynn Yoffee, 770-361-4789;

lynn.yoffee@ahcmedia.com