Medical Device Daily

Aethlon Medical (San Diego) has reached a milestone in its development of the first medical device to treat infectious disease. The publicly traded company reported the successful completion of a human safety study of the Hemopurifier, a filtration device intended to deliver an immune response process for clearing pathogens and toxins from the body's circulation.

“We were able to demonstrate safety of the Hemopurifier in patients who had both renal failure and were co-infected with hepatitis C,” Chairman, President and CEO James Joyce told Medical Device Daily. “The reason why that is such a big milestone is that is a trigger event for us to start filing IDEs [investigational device exemptions] with the FDA here in United States as well as a trigger event to pursue efficacy studies in different disease states outside of the U.S.”

Joyce said the first-in-man study, conducted at Apollo Hospital (Delhi, India), “is the primary trigger that launches a broad spectrum of activity for our company.” The Hemopurifier has been in development since 2001 as a potential treatment countermeasure against drug and vaccine resistant bioweapons, naturally evolving pandemic threats, and chronic infectious disease conditions such as HIV and hepatitis C.

Aethlon will include data from the study in pandemic influenza and Class A biological weapon regulatory filings – the first treatment markets the company is focusing on – with the FDA.

Joyce, an active participant in the emerging biodefense industry, described Class A pathogens as “those that are the greatest threats as potential biological weapons” and said he believes the Hemopurifier has the potential to treat nearly a dozen of them.

Paralleling the company's efforts in this area are plans to submit an IDE for H5N1 avian flu to the FDA. The company in April applied for an avian flu-related treatment grant from the National Institutes of Health for deployment of the Hemopurifier as a therapy to clear inflammatory cytokines, H5N1 avian flu virus and viral fragments that stimulate viral sepsis.

While acknowledging that “it is hard to know if that viral asteroid in regards to humans will really hit,” Joyce said avian flu “is a good topic for us because it demonstrates just how challenging it can be to treat naturally mutating viral conditions, even when you have the global pharmaceutical industry participating.”

Instrumental to the company's success, he said, is the Hemopurifier's ability to provide treatment options where few currently exist. “We feel there are numerous voids where there is an absence of treatment where we can participate in the marketplace,” Joyce said. “At the same time, we think even when treatments are available, the Hemopurifier could be an excellent conjunctive therapy.”

A simplistic way to look at the Hemopurifier, Joyce said, is as an “artificial mechanism to replicate the immune system's process of clearing viruses and toxins before cells and organs get infected.”

The device is a hollow fiber cartridge that can be deployed as a treatment in both the clinic and in the field. In clinical applications, the Hemopurifier would be incorporated into the established global network of dialysis machines.

“That is the ultimate treatment infrastructure because that allows for very rapid flow rates to get the greatest clearance of pathogens from the blood,” Joyce said.

In the case of an infectious disease outbreak, “we would look to deploy our cartridges in a mobile setting either through the use of portable pumps, or through the direct connection to the body without any type of pumping device, where your heart surgeon is the pumping engine,” he said.

The Hemopurifier converges the established principles of hollow-fiber dialysis and affinity chromatography with the discovery of affinity agents that selectively bind envelope viruses.

Unlike dialysis, however, “we do not have a dialysate that circulates inside of our cartridge – our cartridges are sealed.” Joyce said that this aspect “allows us to go mobile with this type of treatment.”

The Hemopurifier's affinity treatment cartridge separates and captures circulating viruses, viral proteins and toxins before the occurrence of cell and organ infection.

“The transference to the immobilization of affinity agents that have broad spectrum affinity to a wide range of pathogens really is a big advantage for us in areas like biodefense and areas like HIV where the virus generally mutates to defeat available drug actions,” Joyce said. “That is really a crucial component of our technology.”

It also is beneficial to the company's regulatory efforts. “The same cartridge that we will be commercializing as a treatment for a biological weapon target would be the same cartridge that we would deploy against HIV or hepatitis C, so the data that we achieve for treating one condition would be included in other types of filings.”

The Hemopurifier may have additional benefits as well, Joyce said. “We're starting to learn that our cartridge may have dual mechanisms of action. In addition to capturing the virus itself, it may be an excellent tool for modulating the overproduction of cytokines,” which he said is a challenging aspect of H5N1, for example.

But, Joyce emphasized, the Hemopurifier is not a cure. “It's a means of working in conjunction with established drug therapies to remove mutant strains of the virus that cause drugs to be ineffective.” He said the role of the device in treating acute conditions is “to provide the immune system a bridge to finish the job and clear the pathogens out of circulation.”

Aethlon is pursuing regulatory initiatives to demonstrate further safety and potential efficacy of the Hemopurifier, which will be treated as a Class III medical device in U.S. regulatory submissions.

“I'm confident that this year we will be proceeding forward in our human safety studies relating to acute conditions in the U.S. such as biological weapon candidates and H5N1 avian flu,” Joyce said. In the near future, he said Aethlon plans to conduct an efficacy study, most likely on Dengue hemorrhagic fever, in India.

The company has also initiated early stage research on a second generation Hemopurifier that targets the capture of growth factors inherent in the spread of cancer. Aethlon in April submitted a grant application to the National Institutes of Health for cancer research.

Though declining to predict when the Hemopurifier would be commercially available, Joyce is optimistic. “There is certainly a lot of opportunity to fill voids, and I think we are in a good position.”

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