Medical Device Daily

It has taken almost a decade of work, but now Aethlon Medical (San Diego) is on the verge of releasing first-in-human study data on its flagship Hemopurifier, the first extracorporeal device to treat HIV infection.

The dialysis-type machine works by mimicking the natural immune response of clearing infectious viruses and toxins before cells and organs can be infected.

Aethlon's study data from treatment of a single patient won't be ready to release until mid-February, but the chairman/CEO told Medical Device Daily that "We're very optimistic."

Hemopurifier provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles. It's also positioned to address the treatment of drug and vaccine resistant viruses.

"We had very good outcomes in hepatitis C (HCV) patients," Jim Joyce, chairman/CEO of Aethlon said. "When we look at the strength of our in vitro data, we're optimistic. We're certainly anxious to get the data for the HIV study."

In this first test in a human, an HIV-infected individual completed 12-treatments with Aethlon Hemopurifier administered thrice weekly over the course of 30-days.

"This first treatment will give us an idea of where to go to next," Joyce said. "We hope to demonstrate the Hemopurifier will act as a single therapeutic. We've completed our 30 day case study, but the only thing to report now is that we didn't' have any observed adverse events and the patient feels good and has an improved appetite. Full data will come next month."

The Hemopurifier is meant to serve as an artificial adjunct to the immune system. In HIV care, it targets the clearance of all circulating strains of infectious HIV, including those varieties that cause patients to fail antiviral drug regimens. Hemopurifier also helps to preserve immune response through the removal of gp120 and other toxic proteins shed by HIV to kill-off immune cells, the hallmark of AIDS.

The study was conducted at the Sigma New Life Hospital (Punjab, India) because, Joyce said, it's difficult to find patients in the U.S. who aren't already receiving drug therapy.

Viral load and immune cell data resulting from the test will be revealed in a few weeks.

"This is our first experience in an HIV patient. Based on this finding, we'll make decisions on the next direction. The principal investigator has a host of other candidates to pursue but we want to get a grip on the outcomes for this patient," Joyce said.

In a previous study focused on HCV, treatment with the Hemopurifier resulted in robust viral load reductions in HCV-infected patients who completed a treatment protocol of three, four-hour Hemopurifier treatments every other day during the course of one week. That study was also conducted in India. Some of the results include:

• Patient 1 had a 95% reduction three days post treatment and 89% reduction seven days post treatment.

• Patient 2 had an 85% reduction three days post treatment and 50% reduction seven days post treatment.

• Patient 3 had a 60% reduction three days post treatment and 83% reduction seven days post treatment.

All viral load measurements were performed with real-time quantitative polymerase chain reaction (RT-PCR). Control samples were measured in duplicate while treatment samples were generally measured in triplicate.

Aethlon created the Hemopurifier to fill a treatment void meant to slow the proliferation of drug resistant strains produced by the constantly mutating AIDS virus. Clinical validation would also set up an opportunity to enhance and extend the benefit of both established and candidate drug therapies."

Hemopurifier was first launched in 2001 (MDD, Feb. 9, 2001). The system is a hollow-fiber dialysis cartridge that reduces viral load through the direct physical removal of the HIV in circulation. It is designed for use within an established infrastructure of dialysis machines in hospitals and clinics worldwide.

If successful, the device has potential applications in cancer care as well as other infectious diseases.

Aethlon also previously reported that Hemopurifier was effective in capturing the reconstructed Spanish Flu of 1918 and H5NI avian influenza (MDD, June 4, 2008).

The FDA has indicated that Hemopurifier will be reviewed as a Class III device in regulatory submissions.